Trial Outcomes & Findings for Deprescribing in Patients Living With Dementia With Caregiver and Provider Nudges (NCT NCT06347172)
NCT ID: NCT06347172
Last Updated: 2026-07-30
Results Overview
This is the primary progression criteria for the study, measured on the patient level. This is measured as a composite of the number of eligible PCPs or their PLWD/care partners who view or click on information on or before the primary care provider visit, up to 10 days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
262 participants
Primary outcome timeframe
On or before the primary care provider visit, up to 10 days
Results posted on
2026-07-30
Participant Flow
Providers, patients, and care partners were identified using existing EHR data at BWH.
Of eligible PCPs, 120 were randomly selected to receive the intervention and were enrolled. From these PCPs, we identified 130 patients within the EHR who met eligibility criteria and were considered enrolled. Eligible patients were determined based on their age (≥65 years), use of an enrolled PCP, diagnosis of mild cognitive impairment or Alzheimer's Disease and related dementias, and use of a high-risk medication. 12 care partners of those patients were also identified, resulting in 262 total.
Participant milestones
| Measure |
Nudge Intervention: Providers
PCPs will receive an enhanced EHR alert (nudge) that triggers when a PCP opens an encounter for an eligible patient living with dementia (PLWD). The nudge will provide information about the risks of continued medication use as well as tips and tools to help providers discuss medication discontinuation with patients and care partners. Additionally, the providers will receive a brief message in their in-basket 10 days before the patient's appointment as a reminder.
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Nudge Intervention: Patients
Eligible PLWD of a randomized PCP will receive the nudge intervention which includes a brief recommendation for the PLWD (and care partner, if available) via the linked patient portal prior to upcoming visits (unless explicitly opted out by the PCP) to discuss medications with the PCP at the visit and link to a general handout about medications, unless explicitly opted out by the PCP. For PLWD without a portal account, the handout will be sent to their mailing address recorded in the EHR.
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Nudge Intervention: Care Partners
Eligible PLWD of a randomized PCP will receive the nudge intervention which includes a brief recommendation for the PLWD (and care partner, if available) via the linked patient portal prior to upcoming visits (unless explicitly opted out by the PCP) to discuss medications with the PCP at the visit and link to a general handout about medications, unless explicitly opted out by the PCP. For PLWD without a portal account, the handout will be sent to their mailing address recorded in the EHR.
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|---|---|---|---|
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Overall Study
STARTED
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120
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130
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12
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Overall Study
COMPLETED
|
120
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130
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12
|
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Overall Study
NOT COMPLETED
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Deprescribing in Patients Living With Dementia With Caregiver and Provider Nudges
Baseline characteristics by cohort
| Measure |
Nudge Intervention: Patients
n=130 Participants
Eligible PLWD of a randomized PCP will receive the nudge intervention which includes a brief recommendation for the PLWD (and care partner, if available) via the linked patient portal prior to upcoming visits (unless explicitly opted out by the PCP) to discuss medications with the PCP at the visit and link to a general handout about medications, unless explicitly opted out by the PCP. For PLWD without a portal account, the handout will be sent to their mailing address recorded in the EHR.
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|---|---|
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Age, Continuous
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76.6 years
STANDARD_DEVIATION 8.0 • n=20 Participants
|
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Sex: Female, Male
Female
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105 Participants
n=20 Participants
|
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Sex: Female, Male
Male
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25 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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17 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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113 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=20 Participants
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|
Race (NIH/OMB)
Asian
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2 Participants
n=20 Participants
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|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
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22 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
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90 Participants
n=20 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=20 Participants
|
|
Region of Enrollment
United States
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130 participants
n=20 Participants
|
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English language as primary language
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109 Participants
n=20 Participants
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|
Baseline use of high-risk medication (number of pills)
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219.1 number of pills prescribed
STANDARD_DEVIATION 210.5 • n=20 Participants
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PRIMARY outcome
Timeframe: On or before the primary care provider visit, up to 10 daysPopulation: Number of patients who access nudge intervention information and/or whose provider accesses nudge intervention information
This is the primary progression criteria for the study, measured on the patient level. This is measured as a composite of the number of eligible PCPs or their PLWD/care partners who view or click on information on or before the primary care provider visit, up to 10 days
Outcome measures
| Measure |
Nudge Intervention
n=130 Participants
PCPs will receive an enhanced EHR alert (nudge) that triggers when a PCP opens an encounter for an eligible patient living with dementia (PLWD). The nudge will provide information about the risks of continued medication use as well as tips and tools to help providers discuss medication discontinuation with patients and care partners. Additionally, the providers will receive a brief message in their in-basket 10 days before the patient's appointment as a reminder.
Eligible PLWD of a randomized PCP will receive the nudge intervention which includes a brief recommendation for the PLWD (and care partner, if available) via the linked patient portal prior to upcoming visits (unless explicitly opted out by the PCP) to discuss medications with the PCP at the visit and link to a general handout about medications, unless explicitly opted out by the PCP. For PLWD without a portal account, the handout will be sent to their mailing address recorded in the EHR.
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|---|---|
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Composite of the Percentage of Eligible PCPs or Their PLWD/Care Partners Who View or Click on Information on or Before the Primary Care Provider Visit, up to 10 Days
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103 Participants
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SECONDARY outcome
Timeframe: On the primary care provider visit datePopulation: Number of patients with nudges that fired as intended, measured among patients who had a completed target visit (n=99)
Number of patients who had provider EHR alerts that fired as intended, measured among patients who had a completed target visit (n=99) within EHR data.
Outcome measures
| Measure |
Nudge Intervention
n=99 Participants
PCPs will receive an enhanced EHR alert (nudge) that triggers when a PCP opens an encounter for an eligible patient living with dementia (PLWD). The nudge will provide information about the risks of continued medication use as well as tips and tools to help providers discuss medication discontinuation with patients and care partners. Additionally, the providers will receive a brief message in their in-basket 10 days before the patient's appointment as a reminder.
Eligible PLWD of a randomized PCP will receive the nudge intervention which includes a brief recommendation for the PLWD (and care partner, if available) via the linked patient portal prior to upcoming visits (unless explicitly opted out by the PCP) to discuss medications with the PCP at the visit and link to a general handout about medications, unless explicitly opted out by the PCP. For PLWD without a portal account, the handout will be sent to their mailing address recorded in the EHR.
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|---|---|
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Number of Patients With Nudges That Fire as Intended: Fidelity
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75 Participants
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SECONDARY outcome
Timeframe: Within 60 days on or after the primary care provider visitDiscontinuation or prescribed reduction in dose of at least one high-risk medication of interest within 60 days after the visit using data from the EHR system, measured on the patient-level as the number of patients who have medications discontinued or have a prescribed reduction.
Outcome measures
| Measure |
Nudge Intervention
n=130 Participants
PCPs will receive an enhanced EHR alert (nudge) that triggers when a PCP opens an encounter for an eligible patient living with dementia (PLWD). The nudge will provide information about the risks of continued medication use as well as tips and tools to help providers discuss medication discontinuation with patients and care partners. Additionally, the providers will receive a brief message in their in-basket 10 days before the patient's appointment as a reminder.
Eligible PLWD of a randomized PCP will receive the nudge intervention which includes a brief recommendation for the PLWD (and care partner, if available) via the linked patient portal prior to upcoming visits (unless explicitly opted out by the PCP) to discuss medications with the PCP at the visit and link to a general handout about medications, unless explicitly opted out by the PCP. For PLWD without a portal account, the handout will be sent to their mailing address recorded in the EHR.
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|---|---|
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Discontinuation or Prescribed Reduction in Medication
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14 Participants
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Adverse Events
Nudge Intervention: Patients
Serious events: 59 serious events
Other events: 0 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Nudge Intervention: Patients
n=130 participants at risk
Eligible PLWD of a randomized PCP will receive the nudge intervention which includes a brief recommendation for the PLWD (and care partner, if available) via the linked patient portal prior to upcoming visits (unless explicitly opted out by the PCP) to discuss medications with the PCP at the visit and link to a general handout about medications, unless explicitly opted out by the PCP. For PLWD without a portal account, the handout will be sent to their mailing address recorded in the EHR.
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|---|---|
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Investigations
Emergency Department Visit
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45.4%
59/130 • Number of events 144 • Measured over the follow-up period per patient (60 days)
Data from the electronic health record (EHR) were used to measure outcomes. The team is unable to classify individual AEs as to their severity using information beyond EHR datafiles for this study. All adverse events are thus reported in the Severe Adverse Events table and not the Other (Not Including Serious) Adverse Event Table. Adverse events were not measured or reported for providers or care partners in accordance with our data and safety monitoring plan.
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Investigations
Hospitalization
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43.1%
56/130 • Number of events 114 • Measured over the follow-up period per patient (60 days)
Data from the electronic health record (EHR) were used to measure outcomes. The team is unable to classify individual AEs as to their severity using information beyond EHR datafiles for this study. All adverse events are thus reported in the Severe Adverse Events table and not the Other (Not Including Serious) Adverse Event Table. Adverse events were not measured or reported for providers or care partners in accordance with our data and safety monitoring plan.
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Nervous system disorders
Insomnia
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32.3%
42/130 • Number of events 159 • Measured over the follow-up period per patient (60 days)
Data from the electronic health record (EHR) were used to measure outcomes. The team is unable to classify individual AEs as to their severity using information beyond EHR datafiles for this study. All adverse events are thus reported in the Severe Adverse Events table and not the Other (Not Including Serious) Adverse Event Table. Adverse events were not measured or reported for providers or care partners in accordance with our data and safety monitoring plan.
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Nervous system disorders
Anxiety
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27.7%
36/130 • Number of events 193 • Measured over the follow-up period per patient (60 days)
Data from the electronic health record (EHR) were used to measure outcomes. The team is unable to classify individual AEs as to their severity using information beyond EHR datafiles for this study. All adverse events are thus reported in the Severe Adverse Events table and not the Other (Not Including Serious) Adverse Event Table. Adverse events were not measured or reported for providers or care partners in accordance with our data and safety monitoring plan.
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Nervous system disorders
Headaches
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17.7%
23/130 • Number of events 95 • Measured over the follow-up period per patient (60 days)
Data from the electronic health record (EHR) were used to measure outcomes. The team is unable to classify individual AEs as to their severity using information beyond EHR datafiles for this study. All adverse events are thus reported in the Severe Adverse Events table and not the Other (Not Including Serious) Adverse Event Table. Adverse events were not measured or reported for providers or care partners in accordance with our data and safety monitoring plan.
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Nervous system disorders
Falls
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19.2%
25/130 • Number of events 41 • Measured over the follow-up period per patient (60 days)
Data from the electronic health record (EHR) were used to measure outcomes. The team is unable to classify individual AEs as to their severity using information beyond EHR datafiles for this study. All adverse events are thus reported in the Severe Adverse Events table and not the Other (Not Including Serious) Adverse Event Table. Adverse events were not measured or reported for providers or care partners in accordance with our data and safety monitoring plan.
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Nervous system disorders
Nausea
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6.2%
8/130 • Number of events 22 • Measured over the follow-up period per patient (60 days)
Data from the electronic health record (EHR) were used to measure outcomes. The team is unable to classify individual AEs as to their severity using information beyond EHR datafiles for this study. All adverse events are thus reported in the Severe Adverse Events table and not the Other (Not Including Serious) Adverse Event Table. Adverse events were not measured or reported for providers or care partners in accordance with our data and safety monitoring plan.
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Nervous system disorders
Vomiting
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6.2%
8/130 • Number of events 22 • Measured over the follow-up period per patient (60 days)
Data from the electronic health record (EHR) were used to measure outcomes. The team is unable to classify individual AEs as to their severity using information beyond EHR datafiles for this study. All adverse events are thus reported in the Severe Adverse Events table and not the Other (Not Including Serious) Adverse Event Table. Adverse events were not measured or reported for providers or care partners in accordance with our data and safety monitoring plan.
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|
Nervous system disorders
Dizziness
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15.4%
20/130 • Number of events 26 • Measured over the follow-up period per patient (60 days)
Data from the electronic health record (EHR) were used to measure outcomes. The team is unable to classify individual AEs as to their severity using information beyond EHR datafiles for this study. All adverse events are thus reported in the Severe Adverse Events table and not the Other (Not Including Serious) Adverse Event Table. Adverse events were not measured or reported for providers or care partners in accordance with our data and safety monitoring plan.
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Nervous system disorders
Fractures
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8.5%
11/130 • Number of events 32 • Measured over the follow-up period per patient (60 days)
Data from the electronic health record (EHR) were used to measure outcomes. The team is unable to classify individual AEs as to their severity using information beyond EHR datafiles for this study. All adverse events are thus reported in the Severe Adverse Events table and not the Other (Not Including Serious) Adverse Event Table. Adverse events were not measured or reported for providers or care partners in accordance with our data and safety monitoring plan.
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Nervous system disorders
Drowsiness
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0.77%
1/130 • Number of events 1 • Measured over the follow-up period per patient (60 days)
Data from the electronic health record (EHR) were used to measure outcomes. The team is unable to classify individual AEs as to their severity using information beyond EHR datafiles for this study. All adverse events are thus reported in the Severe Adverse Events table and not the Other (Not Including Serious) Adverse Event Table. Adverse events were not measured or reported for providers or care partners in accordance with our data and safety monitoring plan.
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place