Trial Outcomes & Findings for Implementing Prescriber-Pharmacist Collaborative Care for Evidence-based Anticoagulant Use (NCT NCT05351749)

NCT ID: NCT05351749

Last Updated: 2026-03-30

Results Overview

Existing-prescription notification conditions = Prescriber notification \& Pharmacist notification The number of notifications (in the existing-prescription notification conditions) that are addressed within 7 days/ total number of notifications

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

306 participants

Primary outcome timeframe

Up to 7 days

Results posted on

2026-03-30

Participant Flow

Assignment to conditions for alerts and notifications made upon first receiving either alert or notification. Receiving only alerts or only notifications de facto 'moves' participant to a new condition for only receiving alerts/only notifications. Similarly, if an alert/notification is deemed to not fit study criteria (e.g. if a patient hospitalized for any reason within 7 days of the alert), this may shift the participant's assignment as they no longer have both an alert and a notification.

Participant milestones

Participant milestones
Measure
New-prescription Alert / Existing-prescription Notification to Prescriber
New-prescription Alert: An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription. Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update. Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
New-prescription Alert w/ Referral Option/ Existing-prescription Notification to Prescriber
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance. Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update. Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
New-prescription Alert/ Existing-prescription Notification to Pharmacist
New-prescription Alert: An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription. Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update. Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
New-prescription Alert w/ Referral Option/ Existing-prescription Notification to Pharmacist
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance. Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update. Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
New-prescription Alert/No Notifications
New-prescription Alert/No Notifications: An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription. No Notifications: Prescribers had no prescriptions that triggered a notification during the study period. Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
New-prescription Alert w/Referral Option/No Notifications
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance. No Notifications: Prescribers had no prescriptions that triggered a notification during the study period. Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
No New-prescription Alert/Existing-prescription Notification to Prescriber
No New-prescription Alert: Prescriber had no prescriptions that triggered an alert Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update. Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
No New-prescription Alert/Existing-prescription Notification to Pharmacist
No New-prescription Alert: Prescriber had no prescriptions that triggered an alert Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update. Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
Allocation at Enrollment
STARTED
42
30
37
43
46
57
30
21
Allocation at Enrollment
COMPLETED
39
29
35
40
42
50
24
15
Allocation at Enrollment
NOT COMPLETED
3
1
2
3
4
7
6
6
Post Analysis of Alerts/Notifications
STARTED
39
29
35
40
46
53
24
16
Post Analysis of Alerts/Notifications
COMPLETED
39
29
35
40
46
53
24
16
Post Analysis of Alerts/Notifications
NOT COMPLETED
0
0
0
0
0
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
New-prescription Alert / Existing-prescription Notification to Prescriber
New-prescription Alert: An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription. Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update. Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
New-prescription Alert w/ Referral Option/ Existing-prescription Notification to Prescriber
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance. Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update. Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
New-prescription Alert/ Existing-prescription Notification to Pharmacist
New-prescription Alert: An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription. Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update. Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
New-prescription Alert w/ Referral Option/ Existing-prescription Notification to Pharmacist
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance. Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update. Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
New-prescription Alert/No Notifications
New-prescription Alert/No Notifications: An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription. No Notifications: Prescribers had no prescriptions that triggered a notification during the study period. Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
New-prescription Alert w/Referral Option/No Notifications
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance. No Notifications: Prescribers had no prescriptions that triggered a notification during the study period. Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
No New-prescription Alert/Existing-prescription Notification to Prescriber
No New-prescription Alert: Prescriber had no prescriptions that triggered an alert Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update. Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
No New-prescription Alert/Existing-prescription Notification to Pharmacist
No New-prescription Alert: Prescriber had no prescriptions that triggered an alert Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update. Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
Allocation at Enrollment
Moved to another arm based on actual hospital experience
2
1
2
3
0
0
0
0
Allocation at Enrollment
Participants dropped from the analysis (because patients no longer fit criteria)
1
0
0
0
4
7
6
6

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
New-prescription Alert/ Existing-prescription Notification to Pharmacist
n=37 Participants
New-prescription Alert: An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription. Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
New-prescription Alert / Existing-prescription Notification to Prescriber
n=42 Participants
New-prescription Alert: An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription. Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
New-prescription Alert w/ Referral Option/ Existing-prescription Notification to Prescriber
n=30 Participants
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance. Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
New-prescription Alert w/ Referral Option/ Existing-prescription Notification to Pharmacist
n=43 Participants
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance. Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
New-prescription Alert/No Notifications
n=46 Participants
New-prescription Alert/No Notifications: An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription. No Notifications: Prescribers had no prescriptions that triggered a notification during the study period.
New-prescription Alert w/Referral Option/No Notifications
n=57 Participants
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance. No Notifications: Prescribers had no prescriptions that triggered a notification during the study period.
No New-prescription Alert/Existing-prescription Notification to Prescriber
n=30 Participants
No New-prescription Alert: Prescriber had no prescriptions that triggered an alert Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
No New-prescription Alert/Existing-prescription Notification to Pharmacist
n=21 Participants
No New-prescription Alert: Prescriber had no prescriptions that triggered an alert Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
Total
n=306 Participants
Total of all reporting groups
Age, Customized
Age >= 18 years
37 Participants
n=37 Participants
42 Participants
n=42 Participants
30 Participants
n=30 Participants
43 Participants
n=43 Participants
46 Participants
n=46 Participants
57 Participants
n=57 Participants
30 Participants
n=30 Participants
21 Participants
n=21 Participants
306 Participants
n=306 Participants
Sex: Female, Male
Female
21 Participants
n=37 Participants
27 Participants
n=42 Participants
19 Participants
n=30 Participants
25 Participants
n=43 Participants
26 Participants
n=46 Participants
37 Participants
n=57 Participants
22 Participants
n=30 Participants
14 Participants
n=21 Participants
191 Participants
n=306 Participants
Sex: Female, Male
Male
16 Participants
n=37 Participants
15 Participants
n=42 Participants
11 Participants
n=30 Participants
18 Participants
n=43 Participants
20 Participants
n=46 Participants
20 Participants
n=57 Participants
8 Participants
n=30 Participants
7 Participants
n=21 Participants
115 Participants
n=306 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
37 participants
n=37 Participants
42 participants
n=42 Participants
30 participants
n=30 Participants
43 participants
n=43 Participants
46 participants
n=46 Participants
57 participants
n=57 Participants
30 participants
n=30 Participants
21 participants
n=21 Participants
306 participants
n=306 Participants
Clinical Role
House Officer
3 Participants
n=37 Participants
0 Participants
n=42 Participants
1 Participants
n=30 Participants
1 Participants
n=43 Participants
10 Participants
n=46 Participants
9 Participants
n=57 Participants
6 Participants
n=30 Participants
3 Participants
n=21 Participants
33 Participants
n=306 Participants
Clinical Role
Primary Care Clinician
21 Participants
n=37 Participants
29 Participants
n=42 Participants
18 Participants
n=30 Participants
30 Participants
n=43 Participants
13 Participants
n=46 Participants
22 Participants
n=57 Participants
13 Participants
n=30 Participants
9 Participants
n=21 Participants
155 Participants
n=306 Participants
Clinical Role
Specialty Care Clinician
13 Participants
n=37 Participants
13 Participants
n=42 Participants
11 Participants
n=30 Participants
12 Participants
n=43 Participants
23 Participants
n=46 Participants
26 Participants
n=57 Participants
11 Participants
n=30 Participants
9 Participants
n=21 Participants
118 Participants
n=306 Participants

PRIMARY outcome

Timeframe: Up to 7 days

Population: Participants analyzed for this outcome all received an existing prescription notification (randomized to prescriber vs pharmacist recipient), regardless of if that participant was exposed to a new medication alert.

Existing-prescription notification conditions = Prescriber notification \& Pharmacist notification The number of notifications (in the existing-prescription notification conditions) that are addressed within 7 days/ total number of notifications

Outcome measures

Outcome measures
Measure
Notification Sent to Prescriber
n=92 Participants
All notifications sent to prescriber participants across all alert conditions
Notification Sent to Pharmacist
n=91 Participants
All notifications sent to pharmacist participants across all alert conditions
The Number (Proportion) of Notifications (in the Existing-prescription Notification Conditions) That Are Addressed Within 7 Days.
24.86 percent of notifications
21.74 percent of notifications

SECONDARY outcome

Timeframe: Up to 7 days

Population: Participants analyzed for this outcome all received a new prescription alert (randomized to include or not include a pharmacist referral option), regardless of if that participant was exposed to an existing prescription notification.

Newly prescribed DOAC alert conditions= Medication alert \& Medication alert + referral Data reported represents the number of alerts (in the newly prescribed DOAC alert conditions) that are addressed within 7 days/ total number of alerts

Outcome measures

Outcome measures
Measure
Notification Sent to Prescriber
n=120 Participants
All notifications sent to prescriber participants across all alert conditions
Notification Sent to Pharmacist
n=122 Participants
All notifications sent to pharmacist participants across all alert conditions
The Number (Proportion) of Alerts (in the Newly Prescribed DOAC Alert Conditions) That Are Addressed Within 7 Days.
29.84 percentage of alerts
29.10 percentage of alerts

SECONDARY outcome

Timeframe: Month 0 to 19 months

Reported on at the institution level (not individual level). Existing-prescription notification conditions = Prescriber notification \& Pharmacist notification The number of notifications (in the existing-prescription notification conditions) that are addressed within 7 days/ total number of notifications, shown over multiple time periods. This outcome measure analysis is based on the results of outcome #1.

Outcome measures

Outcome measures
Measure
Notification Sent to Prescriber
n=203 Participants
All notifications sent to prescriber participants across all alert conditions
Notification Sent to Pharmacist
All notifications sent to pharmacist participants across all alert conditions
Change in Effect Size for the Existing-prescription Notification Over Time
Months 0-6
17.58 percent of notifications
Change in Effect Size for the Existing-prescription Notification Over Time
Months 7-12
27.95 percent of notifications
Change in Effect Size for the Existing-prescription Notification Over Time
Months 13-19
25.81 percent of notifications

SECONDARY outcome

Timeframe: Month 0 to 19 months

Population: Out of 255 participants who received alerts, 13 participants' data was determined to be ineligible

Reported on at the institution level (not individual level). Newly prescribed DOAC alert condition= Medication alert \& Medication alert + referral The number of new prescription alerts that are addressed within 7 days/ total number of alerts, shown over multiple time periods. This outcome measure analysis is based on the results of outcome #2.

Outcome measures

Outcome measures
Measure
Notification Sent to Prescriber
n=242 Participants
All notifications sent to prescriber participants across all alert conditions
Notification Sent to Pharmacist
All notifications sent to pharmacist participants across all alert conditions
Change in Effect Size for the Initial Alert Over Time
7 -12 months
28.47 percentage of alerts
Change in Effect Size for the Initial Alert Over Time
0-6 months
30.06 percentage of alerts
Change in Effect Size for the Initial Alert Over Time
13 - 19 months
29.63 percentage of alerts

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days from alert or notification

Data was gathered from the patients of participants within 30 days of a notification being sent via post-hoc examination of electronic medical record data Clinical adverse events assessed will include major 21 and clinically-relevant non-major bleeding (CRNMB)22 events, as defined by the International Society on Thrombosis and Haemostasis (ISTH), new or recurrent VTE events, and stroke or systemic arterial embolic events. Each of these events will be captured using health informatics tools (described below) and independently adjudicated by two expert clinicians (one pharmacist, one prescriber) who meet once in Y1 and twice in Y2 to adjudicate any potential adverse events. We will use two Michigan Medicine-developed health informatics tools, DataDirect and EMERSE,23 to identify adverse events and capture clinical data (e.g., notes, labs, imaging, procedure reports) for adjudication.

Outcome measures

Outcome data not reported

Adverse Events

New-prescription Alert / Existing-prescription Notification to Prescriber

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

New-prescription Alert w/ Referral Option/ Existing-prescription Notification to Prescriber

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

New-prescription Alert/ Existing-prescription Notification to Pharmacist

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

New-prescription Alert w/ Referral Option/ Existing-prescription Notification to Pharmacist

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

New-prescription Alert/No Notifications

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

New-prescription Alert w/Referral Option/No Notifications

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No New-prescription Alert/Existing-prescription Notification to Prescriber

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No New-prescription Alert/Existing-prescription Notification to Pharmacist

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Geoffrey Barnes, MD, MSc

University of Michigan

Phone: 888-287-1082

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place