Trial Outcomes & Findings for Optimizing Electronic Health Record Prompts With Behavioral Economics to Improve Prescribing for Older Adults (NCT NCT04284553)
NCT ID: NCT04284553
Last Updated: 2024-11-07
Results Overview
This outcome is measured as a composite of 1) discontinuation of study high-risk medications (i.e., active discontinuation or lack of an order during follow-up) or 2) ordering a dose taper (for benzodiazepine or sedative hypnotics) using EHR data by the primary care provider included in the study arm. If any of these actions occurred by the primary care provider, then the patient was considered to have had a change in prescribing (i.e., a reduction in inappropriate prescribing). This outcome was measured as a binary outcome. As noted in the Outcome Measure Time Frame below, these outcomes were measured and presented across both stages of the adaptive trial at Atrius Health rather than separately, as this was part of the pre-specified analytic plan.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
216 participants
Primary outcome timeframe
22 months (2 stages)
Results posted on
2024-11-07
Participant Flow
Atrius primary care providers were cluster-randomized to these arms based on data available from the electronic health record and were not recruited directly for the trial or evaluated for effectiveness outcomes. Patients were also not intervened upon nor directly enrolled into the study. As such, we received a waiver of informed consent for participation. The Mass General Brigham trial described in the protocol is a different record (NCT05538065).
Primary care providers were identified from electronic health record data and cluster randomized to a study arm in Stage 1. Patients who sought care from these primary care providers were identified based on electronic health record data for analyses. Providers were not assessed for effectiveness outcomes. After the interim analysis, primary care providers were re-randomized to a study arm in Stage 2.
Participant milestones
| Measure |
Base Order Entry Alert
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Base Open Encounter Alert
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Follow-up Booster Alert
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Follow-up booster Alert: Once the order entry or open encounter alert displays, the provider will have the option to schedule a follow-up message that will be sent 4 weeks after the alert is triggered
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Follow-up Booster Alert
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Follow-up booster Alert: Once the order entry or open encounter alert displays, the provider will have the option to schedule a follow-up message that will be sent 4 weeks after the alert is triggered
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Cold State Outreach
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Cold State outreach: An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Cold State Outreach
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Cold State outreach: An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Simplified
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Simplified: The alert language itself will be simplified.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Simplified
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Simplified: The alert language itself will be simplified.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Sign-off Alert
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Sign-off alert: An alert will display in the electronic health record when the medication is sent to sign-off for providers.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Sign-off Alert
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Sign-off alert: An alert will display in the electronic health record when the medication is sent to sign-off for providers.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Pre-commitment
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Pre-commitment: A two-staged pre-commitment electronic health record alert will be used. In the 1st alert, the providers will be prompted to discuss risks of these high-risk medications and share a handout about the risks with their patients, at their own discretion. The second alert will be either an order entry or open encounter alert, depending on the arm the provider is assigned to.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Pre-commitment
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Pre-commitment: A two-staged pre-commitment electronic health record alert will be used. In the 1st alert, the providers will be prompted to discuss risks of these high-risk medications and share a handout about the risks with their patients, at their own discretion. The second alert will be either an order entry or open encounter alert, depending on the arm the provider is assigned to.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Different Risks
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Different Risks: Risks of the high-risk medications will be framed differently.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Different Risks
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Different Risks: Risks of the high-risk medications will be framed differently.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Standard Epic Basic Alert
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Standard Epic Basic Alert: This alert will be representative of the alerts currently firing in the Atrius system and not incorporate any functionality.
|
No Alert (Usual Care)
Providers randomized to usual care will receive no EHR tool, as is current clinical practice.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: October 2020-August 2021
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
81
|
|
Stage 1: October 2020-August 2021
Number of Patients Analyzed
|
91
|
91
|
87
|
140
|
174
|
102
|
130
|
104
|
153
|
113
|
118
|
147
|
87
|
90
|
109
|
1173
|
|
Stage 1: October 2020-August 2021
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
81
|
|
Stage 1: October 2020-August 2021
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2: September 2021-August 2022
STARTED
|
0
|
27
|
0
|
27
|
0
|
0
|
0
|
28
|
0
|
28
|
0
|
27
|
0
|
0
|
0
|
60
|
|
Stage 2: September 2021-August 2022
Number of Patients Analyzed
|
0
|
15
|
0
|
35
|
0
|
0
|
0
|
33
|
0
|
23
|
0
|
17
|
0
|
0
|
0
|
31
|
|
Stage 2: September 2021-August 2022
COMPLETED
|
0
|
27
|
0
|
27
|
0
|
0
|
0
|
28
|
0
|
28
|
0
|
27
|
0
|
0
|
0
|
60
|
|
Stage 2: September 2021-August 2022
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimizing Electronic Health Record Prompts With Behavioral Economics to Improve Prescribing for Older Adults
Baseline characteristics by cohort
| Measure |
Base Order Entry Alert
n=91 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Base Open Encounter Alert
n=106 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Follow-up Booster Alert
n=87 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Follow-up booster Alert: Once the order entry or open encounter alert displays, the provider will have the option to schedule a follow-up message that will be sent 4 weeks after the alert is triggered
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Follow-up Booster Alert
n=175 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Follow-up booster Alert: Once the order entry or open encounter alert displays, the provider will have the option to schedule a follow-up message that will be sent 4 weeks after the alert is triggered
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Cold State Outreach
n=174 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Cold State outreach: An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Cold State Outreach
n=102 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Cold State outreach: An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Simplified
n=130 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Simplified: The alert language itself will be simplified.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Simplified
n=137 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Simplified: The alert language itself will be simplified.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Sign-off Alert
n=153 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Sign-off alert: An alert will display in the electronic health record when the medication is sent to sign-off for providers.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Sign-off Alert
n=136 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Sign-off alert: An alert will display in the electronic health record when the medication is sent to sign-off for providers.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Pre-commitment
n=118 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Pre-commitment: A two-staged pre-commitment electronic health record alert will be used. In the 1st alert, the providers will be prompted to discuss risks of these high-risk medications and share a handout about the risks with their patients, at their own discretion. The second alert will be either an order entry or open encounter alert, depending on the arm the provider is assigned to.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Pre-commitment
n=164 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Pre-commitment: A two-staged pre-commitment electronic health record alert will be used. In the 1st alert, the providers will be prompted to discuss risks of these high-risk medications and share a handout about the risks with their patients, at their own discretion. The second alert will be either an order entry or open encounter alert, depending on the arm the provider is assigned to.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Different Risks
n=87 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Different Risks: Risks of the high-risk medications will be framed differently.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Different Risks
n=90 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Different Risks: Risks of the high-risk medications will be framed differently.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Standard Epic Basic Alert
n=109 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Standard Epic Basic Alert: This alert will be representative of the alerts currently firing in the Atrius system and not incorporate any functionality.
|
No Alert (Usual Care)
n=1204 Participants
Providers randomized to usual care will receive no EHR tool, as is current clinical practice.
|
Total
n=3063 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
75.6 years
STANDARD_DEVIATION 7.0 • n=99 Participants
|
73.2 years
STANDARD_DEVIATION 6.3 • n=107 Participants
|
73.7 years
STANDARD_DEVIATION 6.6 • n=206 Participants
|
74.2 years
STANDARD_DEVIATION 6.8 • n=157 Participants
|
74.4 years
STANDARD_DEVIATION 7.3 • n=390 Participants
|
74.1 years
STANDARD_DEVIATION 7.4 • n=16 Participants
|
7.7 years
STANDARD_DEVIATION 7.5 • n=3 Participants
|
74.0 years
STANDARD_DEVIATION 7.1 • n=6 Participants
|
75.5 years
STANDARD_DEVIATION 7.6 • n=114 Participants
|
75.8 years
STANDARD_DEVIATION 7.7 • n=23 Participants
|
72.9 years
STANDARD_DEVIATION 5.8 • n=3 Participants
|
73.6 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
75.6 years
STANDARD_DEVIATION 7.5 • n=3 Participants
|
74.1 years
STANDARD_DEVIATION 7.5 • n=2 Participants
|
77.0 years
STANDARD_DEVIATION 8.2 • n=333 Participants
|
74.3 years
STANDARD_DEVIATION 7.0 • n=6 Participants
|
74.5 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
129 Participants
n=157 Participants
|
145 Participants
n=390 Participants
|
56 Participants
n=16 Participants
|
87 Participants
n=3 Participants
|
110 Participants
n=6 Participants
|
101 Participants
n=114 Participants
|
100 Participants
n=23 Participants
|
80 Participants
n=3 Participants
|
106 Participants
n=5 Participants
|
58 Participants
n=3 Participants
|
44 Participants
n=2 Participants
|
73 Participants
n=333 Participants
|
759 Participants
n=6 Participants
|
2041 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
46 Participants
n=157 Participants
|
29 Participants
n=390 Participants
|
46 Participants
n=16 Participants
|
43 Participants
n=3 Participants
|
27 Participants
n=6 Participants
|
52 Participants
n=114 Participants
|
36 Participants
n=23 Participants
|
38 Participants
n=3 Participants
|
58 Participants
n=5 Participants
|
29 Participants
n=3 Participants
|
46 Participants
n=2 Participants
|
36 Participants
n=333 Participants
|
445 Participants
n=6 Participants
|
1022 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian, Alaska Native, Native Hawaiian, or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=333 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
2 Participants
n=16 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=333 Participants
|
23 Participants
n=6 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
5 Participants
n=390 Participants
|
7 Participants
n=16 Participants
|
4 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
4 Participants
n=23 Participants
|
1 Participants
n=3 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=333 Participants
|
31 Participants
n=6 Participants
|
84 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
86 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
163 Participants
n=157 Participants
|
144 Participants
n=390 Participants
|
87 Participants
n=16 Participants
|
118 Participants
n=3 Participants
|
126 Participants
n=6 Participants
|
147 Participants
n=114 Participants
|
123 Participants
n=23 Participants
|
112 Participants
n=3 Participants
|
149 Participants
n=5 Participants
|
80 Participants
n=3 Participants
|
82 Participants
n=2 Participants
|
93 Participants
n=333 Participants
|
1051 Participants
n=6 Participants
|
2723 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
4 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=2 Participants
|
5 Participants
n=333 Participants
|
24 Participants
n=6 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
18 Participants
n=390 Participants
|
2 Participants
n=16 Participants
|
4 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
5 Participants
n=23 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=2 Participants
|
1 Participants
n=333 Participants
|
50 Participants
n=6 Participants
|
109 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
2 Participants
n=16 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
4 Participants
n=23 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=333 Participants
|
21 Participants
n=6 Participants
|
49 Participants
n=5 Participants
|
|
Benzodiazepine quantity: Number of pills prescribed in past 180 days measured in EHR system
|
187.9 number of pills prescribed
STANDARD_DEVIATION 135.9 • n=99 Participants
|
200.0 number of pills prescribed
STANDARD_DEVIATION 118.6 • n=107 Participants
|
186.9 number of pills prescribed
STANDARD_DEVIATION 116.4 • n=206 Participants
|
195.6 number of pills prescribed
STANDARD_DEVIATION 118.2 • n=157 Participants
|
222.0 number of pills prescribed
STANDARD_DEVIATION 293.3 • n=390 Participants
|
218.0 number of pills prescribed
STANDARD_DEVIATION 233.2 • n=16 Participants
|
209.9 number of pills prescribed
STANDARD_DEVIATION 175.4 • n=3 Participants
|
199.2 number of pills prescribed
STANDARD_DEVIATION 122.6 • n=6 Participants
|
214.5 number of pills prescribed
STANDARD_DEVIATION 158.0 • n=114 Participants
|
185.1 number of pills prescribed
STANDARD_DEVIATION 115.7 • n=23 Participants
|
227.7 number of pills prescribed
STANDARD_DEVIATION 151.2 • n=3 Participants
|
205.2 number of pills prescribed
STANDARD_DEVIATION 145.5 • n=5 Participants
|
220.3 number of pills prescribed
STANDARD_DEVIATION 155.4 • n=3 Participants
|
229.7 number of pills prescribed
STANDARD_DEVIATION 220.0 • n=2 Participants
|
190.5 number of pills prescribed
STANDARD_DEVIATION 119.9 • n=333 Participants
|
203.1 number of pills prescribed
STANDARD_DEVIATION 149.4 • n=6 Participants
|
205.2 number of pills prescribed
STANDARD_DEVIATION 162.0 • n=5 Participants
|
|
Sedative hypnotic quantity: Number of pills prescribed in past 180 days measured in EHR system
|
132.1 number of pills prescribed
STANDARD_DEVIATION 70.9 • n=99 Participants
|
154.4 number of pills prescribed
STANDARD_DEVIATION 71.3 • n=107 Participants
|
143.4 number of pills prescribed
STANDARD_DEVIATION 66.6 • n=206 Participants
|
138.0 number of pills prescribed
STANDARD_DEVIATION 64.3 • n=157 Participants
|
153.3 number of pills prescribed
STANDARD_DEVIATION 87.7 • n=390 Participants
|
107.5 number of pills prescribed
STANDARD_DEVIATION 31.5 • n=16 Participants
|
130.0 number of pills prescribed
STANDARD_DEVIATION 74.1 • n=3 Participants
|
150.1 number of pills prescribed
STANDARD_DEVIATION 76.5 • n=6 Participants
|
145.0 number of pills prescribed
STANDARD_DEVIATION 53.6 • n=114 Participants
|
154.9 number of pills prescribed
STANDARD_DEVIATION 81.9 • n=23 Participants
|
172.7 number of pills prescribed
STANDARD_DEVIATION 73.2 • n=3 Participants
|
136.8 number of pills prescribed
STANDARD_DEVIATION 55.3 • n=5 Participants
|
146.8 number of pills prescribed
STANDARD_DEVIATION 64.7 • n=3 Participants
|
150.7 number of pills prescribed
STANDARD_DEVIATION 64.9 • n=2 Participants
|
162.3 number of pills prescribed
STANDARD_DEVIATION 100.7 • n=333 Participants
|
147.6 number of pills prescribed
STANDARD_DEVIATION 73.7 • n=6 Participants
|
147.1 number of pills prescribed
STANDARD_DEVIATION 72.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 22 months (2 stages)Population: Patients who met eligibility criteria for inclusion in the analysis (adults ≥65 years, who were prescribed ≥90 pills of benzodiazepine or sedative hypnotic in the last 180 days and had an office or telemedicine visit with a primary care provider who was assigned to a study arm), as measured from EHR system data across Stages 1 and 2
This outcome is measured as a composite of 1) discontinuation of study high-risk medications (i.e., active discontinuation or lack of an order during follow-up) or 2) ordering a dose taper (for benzodiazepine or sedative hypnotics) using EHR data by the primary care provider included in the study arm. If any of these actions occurred by the primary care provider, then the patient was considered to have had a change in prescribing (i.e., a reduction in inappropriate prescribing). This outcome was measured as a binary outcome. As noted in the Outcome Measure Time Frame below, these outcomes were measured and presented across both stages of the adaptive trial at Atrius Health rather than separately, as this was part of the pre-specified analytic plan.
Outcome measures
| Measure |
Base Order Entry Alert
n=91 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Base Open Encounter Alert
n=106 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Follow-up Booster Alert
n=87 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Follow-up booster Alert: Once the order entry or open encounter alert displays, the provider will have the option to schedule a follow-up message that will be sent 4 weeks after the alert is triggered
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Follow-up Booster Alert
n=175 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Follow-up booster Alert: Once the order entry or open encounter alert displays, the provider will have the option to schedule a follow-up message that will be sent 4 weeks after the alert is triggered
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Cold State Outreach
n=174 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Cold State outreach: An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Cold State Outreach
n=102 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Cold State outreach: An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Simplified
n=130 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Simplified: The alert language itself will be simplified.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Simplified
n=137 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Simplified: The alert language itself will be simplified.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Sign-off Alert
n=153 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Sign-off alert: An alert will display in the electronic health record when the medication is sent to sign-off for providers.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Sign-off Alert
n=136 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Sign-off alert: An alert will display in the electronic health record when the medication is sent to sign-off for providers.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Pre-commitment
n=118 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Pre-commitment: A two-staged pre-commitment electronic health record alert will be used. In the 1st alert, the providers will be prompted to discuss risks of these high-risk medications and share a handout about the risks with their patients, at their own discretion. The second alert will be either an order entry or open encounter alert, depending on the arm the provider is assigned to.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Pre-commitment
n=164 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Pre-commitment: A two-staged pre-commitment electronic health record alert will be used. In the 1st alert, the providers will be prompted to discuss risks of these high-risk medications and share a handout about the risks with their patients, at their own discretion. The second alert will be either an order entry or open encounter alert, depending on the arm the provider is assigned to.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Different Risks
n=87 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Different Risks: Risks of the high-risk medications will be framed differently.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Different Risks
n=90 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Different Risks: Risks of the high-risk medications will be framed differently.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Standard Epic Basic Alert
n=109 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Standard Epic Basic Alert: This alert will be representative of the alerts currently firing in the Atrius system and not incorporate any functionality.
|
No Alert (Usual Care)
n=1204 Participants
Providers randomized to usual care will receive no EHR tool, as is current clinical practice.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms
|
35.2 percentage of patients
|
33 percentage of patients
|
35.6 percentage of patients
|
40.6 percentage of patients
|
25.9 percentage of patients
|
39.2 percentage of patients
|
42.3 percentage of patients
|
38 percentage of patients
|
27.5 percentage of patients
|
29.4 percentage of patients
|
33.9 percentage of patients
|
45.1 percentage of patients
|
28.7 percentage of patients
|
32.2 percentage of patients
|
30.3 percentage of patients
|
33.6 percentage of patients
|
PRIMARY outcome
Timeframe: 22 months (2 stages)Population: Patients who met eligibility criteria for inclusion in the analyses (adults ≥65 years, who were prescribed ≥90 pills of benzodiazepine or sedative hypnotic in the last 180 days and had an office or telemedicine visit with a primary care provider in the trial), as measured in the EHR across Stages 1 and 2. These groups are not mutually exclusive as the study arms could contain multiple intervention factors (e.g., Open Encounter Timing and Boostering); thus, the overall total exceeds 3063.
This outcome is measured as a binary composite of 1) discontinuation of study high-risk medications (i.e., active discontinuation or lack of an order during follow-up) or 2) ordering a dose taper using EHR data by the primary care provider in the arm. If the provider performed any of these actions, then the patient was considered as having a change in prescribing (i.e., a reduction in inappropriate prescribing). As noted in the Time Frame below, these outcomes were measured and analyzed across both Stages of the trial in the primary analysis. The following outcomes are shown stratified by patients who were in arms containing one of the seven behavioral intervention factors and also among those in arms that did not contain an intervention factor. The primary analysis conducts analyses by intervention factor; the model treats patients in arms that do not contain any of the behavioral factors (i.e., Base Order Entry Alert, Standard Epic Basic Alert, and Usual Care) as the referent.
Outcome measures
| Measure |
Base Order Entry Alert
n=910 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Base Open Encounter Alert
n=262 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Follow-up Booster Alert
n=276 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Follow-up booster Alert: Once the order entry or open encounter alert displays, the provider will have the option to schedule a follow-up message that will be sent 4 weeks after the alert is triggered
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Follow-up Booster Alert
n=267 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Follow-up booster Alert: Once the order entry or open encounter alert displays, the provider will have the option to schedule a follow-up message that will be sent 4 weeks after the alert is triggered
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Cold State Outreach
n=289 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Cold State outreach: An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Cold State Outreach
n=282 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Cold State outreach: An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Simplified
n=177 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Simplified: The alert language itself will be simplified.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Simplified
n=1404 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Simplified: The alert language itself will be simplified.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Sign-off Alert
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Sign-off alert: An alert will display in the electronic health record when the medication is sent to sign-off for providers.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Sign-off Alert
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Sign-off alert: An alert will display in the electronic health record when the medication is sent to sign-off for providers.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Pre-commitment
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Pre-commitment: A two-staged pre-commitment electronic health record alert will be used. In the 1st alert, the providers will be prompted to discuss risks of these high-risk medications and share a handout about the risks with their patients, at their own discretion. The second alert will be either an order entry or open encounter alert, depending on the arm the provider is assigned to.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Pre-commitment
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Pre-commitment: A two-staged pre-commitment electronic health record alert will be used. In the 1st alert, the providers will be prompted to discuss risks of these high-risk medications and share a handout about the risks with their patients, at their own discretion. The second alert will be either an order entry or open encounter alert, depending on the arm the provider is assigned to.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Different Risks
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Different Risks: Risks of the high-risk medications will be framed differently.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Different Risks
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Different Risks: Risks of the high-risk medications will be framed differently.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Standard Epic Basic Alert
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Standard Epic Basic Alert: This alert will be representative of the alerts currently firing in the Atrius system and not incorporate any functionality.
|
No Alert (Usual Care)
Providers randomized to usual care will receive no EHR tool, as is current clinical practice.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Inappropriate Prescribing by the Seven Behavioral Intervention Factors (Open Encounter Timing, Boostering, Cold-state Priming, Simplification, Sign-off Approval, Pre-commitment, and Risk Framing): Primary Analysis Approach
|
33.1 percentage of patients
|
38.9 percentage of patients
|
30.8 percentage of patients
|
40.1 percentage of patients
|
28.4 percentage of patients
|
40.4 percentage of patients
|
30.5 percentage of patients
|
33.5 percentage of patients
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 22 months (2 stages)Population: Among eligible study population included (adults ≥65 years, who were prescribed ≥90 pills of benzodiazepine or sedative hypnotic in the last 180 days and had an office or telemedicine visit with a primary care provider assigned to that study arm), as measured from the EHR system across Stages 1 and 2 of the trial.
This outcome is measured on the patient level as the number of cumulative lorazepam milligram equivalents of high-risk medications prescribed to patients by Atrius providers over the follow-up for the relevant adaptive trial stage, measured within the EHR system. This outcome was measured as a continuous outcome. As noted in the Outcome Measure Time Frame below, these outcomes were measured and presented across both stages of the adaptive trial at Atrius Health rather than separately, as this was part of the pre-specified analytic plan.
Outcome measures
| Measure |
Base Order Entry Alert
n=91 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Base Open Encounter Alert
n=106 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Follow-up Booster Alert
n=87 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Follow-up booster Alert: Once the order entry or open encounter alert displays, the provider will have the option to schedule a follow-up message that will be sent 4 weeks after the alert is triggered
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Follow-up Booster Alert
n=175 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Follow-up booster Alert: Once the order entry or open encounter alert displays, the provider will have the option to schedule a follow-up message that will be sent 4 weeks after the alert is triggered
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Cold State Outreach
n=174 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Cold State outreach: An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Cold State Outreach
n=102 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Cold State outreach: An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Simplified
n=130 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Simplified: The alert language itself will be simplified.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Simplified
n=137 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Simplified: The alert language itself will be simplified.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Sign-off Alert
n=153 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Sign-off alert: An alert will display in the electronic health record when the medication is sent to sign-off for providers.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Sign-off Alert
n=136 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Sign-off alert: An alert will display in the electronic health record when the medication is sent to sign-off for providers.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Pre-commitment
n=118 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Pre-commitment: A two-staged pre-commitment electronic health record alert will be used. In the 1st alert, the providers will be prompted to discuss risks of these high-risk medications and share a handout about the risks with their patients, at their own discretion. The second alert will be either an order entry or open encounter alert, depending on the arm the provider is assigned to.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Pre-commitment
n=164 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Pre-commitment: A two-staged pre-commitment electronic health record alert will be used. In the 1st alert, the providers will be prompted to discuss risks of these high-risk medications and share a handout about the risks with their patients, at their own discretion. The second alert will be either an order entry or open encounter alert, depending on the arm the provider is assigned to.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Different Risks
n=87 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Different Risks: Risks of the high-risk medications will be framed differently.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Different Risks
n=90 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Different Risks: Risks of the high-risk medications will be framed differently.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Standard Epic Basic Alert
n=109 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Standard Epic Basic Alert: This alert will be representative of the alerts currently firing in the Atrius system and not incorporate any functionality.
|
No Alert (Usual Care)
n=1204 Participants
Providers randomized to usual care will receive no EHR tool, as is current clinical practice.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms
|
64.5 Cumulative lorazepam mg equivalents
Standard Deviation 87.6
|
119.8 Cumulative lorazepam mg equivalents
Standard Deviation 179.7
|
94.4 Cumulative lorazepam mg equivalents
Standard Deviation 176.5
|
104.7 Cumulative lorazepam mg equivalents
Standard Deviation 170.0
|
156.6 Cumulative lorazepam mg equivalents
Standard Deviation 207.5
|
146.3 Cumulative lorazepam mg equivalents
Standard Deviation 425.3
|
114.2 Cumulative lorazepam mg equivalents
Standard Deviation 181.6
|
110.0 Cumulative lorazepam mg equivalents
Standard Deviation 160.3
|
114.6 Cumulative lorazepam mg equivalents
Standard Deviation 188.7
|
93.6 Cumulative lorazepam mg equivalents
Standard Deviation 147.0
|
107.0 Cumulative lorazepam mg equivalents
Standard Deviation 180.8
|
121.1 Cumulative lorazepam mg equivalents
Standard Deviation 196.7
|
82.0 Cumulative lorazepam mg equivalents
Standard Deviation 90.2
|
118.0 Cumulative lorazepam mg equivalents
Standard Deviation 166.5
|
123.6 Cumulative lorazepam mg equivalents
Standard Deviation 214.4
|
114.4 Cumulative lorazepam mg equivalents
Standard Deviation 194.9
|
SECONDARY outcome
Timeframe: 22 months (2 stages)Population: Patients who met eligibility criteria for inclusion in the analyses (adults ≥65 years, who were prescribed ≥90 pills of benzodiazepine or sedative hypnotic in the last 180 days and had an office or telemedicine visit with a primary care provider in the trial), as measured in the EHR across Stages 1 and 2. These groups are not mutually exclusive as the study arms could contain multiple intervention factors (e.g., Open Encounter Timing and Boostering); thus, the overall total exceeds 3063.
This outcome is measured on the patient level as the cumulative number of lorazepam milligram equivalents of high-risk medications prescribed to patients by Atrius providers over the follow-up for the relevant adaptive trial stage, measured in the EHR system. This outcome was measured as a continuous outcome. As noted in the Time Frame below, these outcomes were measured and analyzed across both Stages of the trial in the primary analysis. The following outcomes are shown stratified by patients who were in arms containing one of the seven behavioral intervention factors and also among those in arms that did not contain an intervention factor. The primary analysis conducts analyses by intervention factor; the model treats patients in arms that do not contain any of the behavioral factors (i.e., Base Order Entry Alert, Standard Epic Basic Alert, and Usual Care) as the referent.
Outcome measures
| Measure |
Base Order Entry Alert
n=910 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Base Open Encounter Alert
n=262 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Follow-up Booster Alert
n=276 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Follow-up booster Alert: Once the order entry or open encounter alert displays, the provider will have the option to schedule a follow-up message that will be sent 4 weeks after the alert is triggered
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Follow-up Booster Alert
n=267 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Follow-up booster Alert: Once the order entry or open encounter alert displays, the provider will have the option to schedule a follow-up message that will be sent 4 weeks after the alert is triggered
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Cold State Outreach
n=289 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Cold State outreach: An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Cold State Outreach
n=282 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Cold State outreach: An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Simplified
n=177 Participants
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Simplified: The alert language itself will be simplified.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Simplified
n=1404 Participants
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Simplified: The alert language itself will be simplified.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Sign-off Alert
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Sign-off alert: An alert will display in the electronic health record when the medication is sent to sign-off for providers.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Sign-off Alert
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Sign-off alert: An alert will display in the electronic health record when the medication is sent to sign-off for providers.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Pre-commitment
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Pre-commitment: A two-staged pre-commitment electronic health record alert will be used. In the 1st alert, the providers will be prompted to discuss risks of these high-risk medications and share a handout about the risks with their patients, at their own discretion. The second alert will be either an order entry or open encounter alert, depending on the arm the provider is assigned to.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Pre-commitment
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Pre-commitment: A two-staged pre-commitment electronic health record alert will be used. In the 1st alert, the providers will be prompted to discuss risks of these high-risk medications and share a handout about the risks with their patients, at their own discretion. The second alert will be either an order entry or open encounter alert, depending on the arm the provider is assigned to.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Different Risks
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Different Risks: Risks of the high-risk medications will be framed differently.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Different Risks
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Different Risks: Risks of the high-risk medications will be framed differently.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Standard Epic Basic Alert
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Standard Epic Basic Alert: This alert will be representative of the alerts currently firing in the Atrius system and not incorporate any functionality.
|
No Alert (Usual Care)
Providers randomized to usual care will receive no EHR tool, as is current clinical practice.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Quantity of Prescribing by the Seven Behavioral Intervention Factors (Open Encounter Timing, Boostering, Cold-state Priming, Simplification, Sign-off Approval, Pre-commitment, and Risk Framing): Primary Analysis Approach
|
114.5 Cumulative lorazepam mg equivalents
Standard Deviation 215.1
|
101.3 Cumulative lorazepam mg equivalents
Standard Deviation 171.9
|
152.8 Cumulative lorazepam mg equivalents
Standard Deviation 305.9
|
112.0 Cumulative lorazepam mg equivalents
Standard Deviation 170.7
|
104.7 Cumulative lorazepam mg equivalents
Standard Deviation 170.4
|
115.2 Cumulative lorazepam mg equivalents
Standard Deviation 190.0
|
100.3 Cumulative lorazepam mg equivalents
Standard Deviation 135.4
|
111.9 Cumulative lorazepam mg equivalents
Standard Deviation 191.8
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
Adverse Events
Base Order Entry Alert
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Base Open Encounter Alert
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Order Entry + Follow-up Booster Alert
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Open Encounter + Follow-up Booster Alert
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Order Entry + Cold State Outreach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Open Encounter + Cold State Outreach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Order Entry + Simplified
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Open Encounter + Simplified
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Order Entry + Sign-off Alert
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Open Encounter + Sign-off Alert
Serious events: 0 serious events
Other events: 0 other events
Deaths: 11 deaths
Order Entry + Pre-commitment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Open Encounter + Pre-commitment
Serious events: 1 serious events
Other events: 0 other events
Deaths: 6 deaths
Order Entry + Different Risks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Open Encounter + Different Risks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Epic Basic Alert
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
No Alert (Usual Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Base Order Entry Alert
n=91 participants at risk
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Base Open Encounter Alert
n=106 participants at risk
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Follow-up Booster Alert
n=87 participants at risk
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Follow-up booster Alert: Once the order entry or open encounter alert displays, the provider will have the option to schedule a follow-up message that will be sent 4 weeks after the alert is triggered
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Follow-up Booster Alert
n=175 participants at risk
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Follow-up booster Alert: Once the order entry or open encounter alert displays, the provider will have the option to schedule a follow-up message that will be sent 4 weeks after the alert is triggered
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Cold State Outreach
n=174 participants at risk
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Cold State outreach: An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Cold State Outreach
n=102 participants at risk
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Cold State outreach: An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Simplified
n=130 participants at risk
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Simplified: The alert language itself will be simplified.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Simplified
n=137 participants at risk
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Simplified: The alert language itself will be simplified.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Sign-off Alert
n=153 participants at risk
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Sign-off alert: An alert will display in the electronic health record when the medication is sent to sign-off for providers.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Sign-off Alert
n=136 participants at risk
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Sign-off alert: An alert will display in the electronic health record when the medication is sent to sign-off for providers.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Pre-commitment
n=118 participants at risk
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Pre-commitment: A two-staged pre-commitment electronic health record alert will be used. In the 1st alert, the providers will be prompted to discuss risks of these high-risk medications and share a handout about the risks with their patients, at their own discretion. The second alert will be either an order entry or open encounter alert, depending on the arm the provider is assigned to.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Pre-commitment
n=164 participants at risk
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Pre-commitment: A two-staged pre-commitment electronic health record alert will be used. In the 1st alert, the providers will be prompted to discuss risks of these high-risk medications and share a handout about the risks with their patients, at their own discretion. The second alert will be either an order entry or open encounter alert, depending on the arm the provider is assigned to.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Order Entry + Different Risks
n=87 participants at risk
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Different Risks: Risks of the high-risk medications will be framed differently.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Open Encounter + Different Risks
n=90 participants at risk
Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Different Risks: Risks of the high-risk medications will be framed differently.
Enhanced Alert: An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
|
Standard Epic Basic Alert
n=109 participants at risk
Order Entry: An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Standard Epic Basic Alert: This alert will be representative of the alerts currently firing in the Atrius system and not incorporate any functionality.
|
No Alert (Usual Care)
n=1204 participants at risk
Providers randomized to usual care will receive no EHR tool, as is current clinical practice.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Intentional overdose
|
0.00%
0/91 • 22 months (2 stages) - these outcomes were measured across both stages of the 2-stage Atrius adaptive trial. The Mass General Brigham trial described in the Study Protocol is listed under a different clinicaltrials.gov record (NCT05538065), as that is a distinct trial.
Deaths and adverse events are reported for patients who were included in the analyses for the trial. Deaths and adverse events were not collected, monitored, or assessed for providers. For patients, we used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. In addition, for patients, we retrospectively identified patient deaths through a retrospective review within the EHR.
|
0.00%
0/106 • 22 months (2 stages) - these outcomes were measured across both stages of the 2-stage Atrius adaptive trial. The Mass General Brigham trial described in the Study Protocol is listed under a different clinicaltrials.gov record (NCT05538065), as that is a distinct trial.
Deaths and adverse events are reported for patients who were included in the analyses for the trial. Deaths and adverse events were not collected, monitored, or assessed for providers. For patients, we used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. In addition, for patients, we retrospectively identified patient deaths through a retrospective review within the EHR.
|
0.00%
0/87 • 22 months (2 stages) - these outcomes were measured across both stages of the 2-stage Atrius adaptive trial. The Mass General Brigham trial described in the Study Protocol is listed under a different clinicaltrials.gov record (NCT05538065), as that is a distinct trial.
Deaths and adverse events are reported for patients who were included in the analyses for the trial. Deaths and adverse events were not collected, monitored, or assessed for providers. For patients, we used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. In addition, for patients, we retrospectively identified patient deaths through a retrospective review within the EHR.
|
0.00%
0/175 • 22 months (2 stages) - these outcomes were measured across both stages of the 2-stage Atrius adaptive trial. The Mass General Brigham trial described in the Study Protocol is listed under a different clinicaltrials.gov record (NCT05538065), as that is a distinct trial.
Deaths and adverse events are reported for patients who were included in the analyses for the trial. Deaths and adverse events were not collected, monitored, or assessed for providers. For patients, we used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. In addition, for patients, we retrospectively identified patient deaths through a retrospective review within the EHR.
|
0.00%
0/174 • 22 months (2 stages) - these outcomes were measured across both stages of the 2-stage Atrius adaptive trial. The Mass General Brigham trial described in the Study Protocol is listed under a different clinicaltrials.gov record (NCT05538065), as that is a distinct trial.
Deaths and adverse events are reported for patients who were included in the analyses for the trial. Deaths and adverse events were not collected, monitored, or assessed for providers. For patients, we used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. In addition, for patients, we retrospectively identified patient deaths through a retrospective review within the EHR.
|
0.00%
0/102 • 22 months (2 stages) - these outcomes were measured across both stages of the 2-stage Atrius adaptive trial. The Mass General Brigham trial described in the Study Protocol is listed under a different clinicaltrials.gov record (NCT05538065), as that is a distinct trial.
Deaths and adverse events are reported for patients who were included in the analyses for the trial. Deaths and adverse events were not collected, monitored, or assessed for providers. For patients, we used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. In addition, for patients, we retrospectively identified patient deaths through a retrospective review within the EHR.
|
0.00%
0/130 • 22 months (2 stages) - these outcomes were measured across both stages of the 2-stage Atrius adaptive trial. The Mass General Brigham trial described in the Study Protocol is listed under a different clinicaltrials.gov record (NCT05538065), as that is a distinct trial.
Deaths and adverse events are reported for patients who were included in the analyses for the trial. Deaths and adverse events were not collected, monitored, or assessed for providers. For patients, we used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. In addition, for patients, we retrospectively identified patient deaths through a retrospective review within the EHR.
|
0.00%
0/137 • 22 months (2 stages) - these outcomes were measured across both stages of the 2-stage Atrius adaptive trial. The Mass General Brigham trial described in the Study Protocol is listed under a different clinicaltrials.gov record (NCT05538065), as that is a distinct trial.
Deaths and adverse events are reported for patients who were included in the analyses for the trial. Deaths and adverse events were not collected, monitored, or assessed for providers. For patients, we used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. In addition, for patients, we retrospectively identified patient deaths through a retrospective review within the EHR.
|
0.00%
0/153 • 22 months (2 stages) - these outcomes were measured across both stages of the 2-stage Atrius adaptive trial. The Mass General Brigham trial described in the Study Protocol is listed under a different clinicaltrials.gov record (NCT05538065), as that is a distinct trial.
Deaths and adverse events are reported for patients who were included in the analyses for the trial. Deaths and adverse events were not collected, monitored, or assessed for providers. For patients, we used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. In addition, for patients, we retrospectively identified patient deaths through a retrospective review within the EHR.
|
0.00%
0/136 • 22 months (2 stages) - these outcomes were measured across both stages of the 2-stage Atrius adaptive trial. The Mass General Brigham trial described in the Study Protocol is listed under a different clinicaltrials.gov record (NCT05538065), as that is a distinct trial.
Deaths and adverse events are reported for patients who were included in the analyses for the trial. Deaths and adverse events were not collected, monitored, or assessed for providers. For patients, we used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. In addition, for patients, we retrospectively identified patient deaths through a retrospective review within the EHR.
|
0.00%
0/118 • 22 months (2 stages) - these outcomes were measured across both stages of the 2-stage Atrius adaptive trial. The Mass General Brigham trial described in the Study Protocol is listed under a different clinicaltrials.gov record (NCT05538065), as that is a distinct trial.
Deaths and adverse events are reported for patients who were included in the analyses for the trial. Deaths and adverse events were not collected, monitored, or assessed for providers. For patients, we used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. In addition, for patients, we retrospectively identified patient deaths through a retrospective review within the EHR.
|
0.61%
1/164 • 22 months (2 stages) - these outcomes were measured across both stages of the 2-stage Atrius adaptive trial. The Mass General Brigham trial described in the Study Protocol is listed under a different clinicaltrials.gov record (NCT05538065), as that is a distinct trial.
Deaths and adverse events are reported for patients who were included in the analyses for the trial. Deaths and adverse events were not collected, monitored, or assessed for providers. For patients, we used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. In addition, for patients, we retrospectively identified patient deaths through a retrospective review within the EHR.
|
0.00%
0/87 • 22 months (2 stages) - these outcomes were measured across both stages of the 2-stage Atrius adaptive trial. The Mass General Brigham trial described in the Study Protocol is listed under a different clinicaltrials.gov record (NCT05538065), as that is a distinct trial.
Deaths and adverse events are reported for patients who were included in the analyses for the trial. Deaths and adverse events were not collected, monitored, or assessed for providers. For patients, we used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. In addition, for patients, we retrospectively identified patient deaths through a retrospective review within the EHR.
|
0.00%
0/90 • 22 months (2 stages) - these outcomes were measured across both stages of the 2-stage Atrius adaptive trial. The Mass General Brigham trial described in the Study Protocol is listed under a different clinicaltrials.gov record (NCT05538065), as that is a distinct trial.
Deaths and adverse events are reported for patients who were included in the analyses for the trial. Deaths and adverse events were not collected, monitored, or assessed for providers. For patients, we used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. In addition, for patients, we retrospectively identified patient deaths through a retrospective review within the EHR.
|
0.00%
0/109 • 22 months (2 stages) - these outcomes were measured across both stages of the 2-stage Atrius adaptive trial. The Mass General Brigham trial described in the Study Protocol is listed under a different clinicaltrials.gov record (NCT05538065), as that is a distinct trial.
Deaths and adverse events are reported for patients who were included in the analyses for the trial. Deaths and adverse events were not collected, monitored, or assessed for providers. For patients, we used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. In addition, for patients, we retrospectively identified patient deaths through a retrospective review within the EHR.
|
0.00%
0/1204 • 22 months (2 stages) - these outcomes were measured across both stages of the 2-stage Atrius adaptive trial. The Mass General Brigham trial described in the Study Protocol is listed under a different clinicaltrials.gov record (NCT05538065), as that is a distinct trial.
Deaths and adverse events are reported for patients who were included in the analyses for the trial. Deaths and adverse events were not collected, monitored, or assessed for providers. For patients, we used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. In addition, for patients, we retrospectively identified patient deaths through a retrospective review within the EHR.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place