Implementing Prescriber-Pharmacist Collaborative Care for Evidence-based Anticoagulant Use

The researchers hypothesize that existing-prescription notifications directed to pharmacists are more likely to lead to a prescription change than existing-prescription notifications directed to prescribers. Furthermore, the researchers hypothesize that the availability of a pharmacist referral option is associated with a higher rate of prescription changes for initial-prescription alerts that are directed to the prescriber at the time of initial-prescribing errors.

Findings from this project will establish a framework for implementing prescriber-pharmacist collaboration for high risk medications, including anticoagulants

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Venous Thromboembolism; Pulmonary Embolism
• Intervention / Treatment: Behavioral: New-prescription Alert; Behavioral: Existing-prescription notification to prescriber; Behavioral: New-prescription Alert with referral option; Behavioral: Existing-prescription notification to pharmacist

Detailed Description

Please note that the 3rd and 4th outcome measures are conditional on the outcomes of the 1st and 2nd outcome measures respectively.

Please note that enrollment of 300 will provide sufficient power to study.

Study data was obtained through data downloads and not from individual participant interactions. Final data collection for all outcomes took place on Dec 15, 2024.

• Study Type: Interventional
• Enrollment (Actual): 306
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Prescribers:

Inclusion Criteria:

• Michigan Medicine provider with prescribing privileges
• Providers in ambulatory care settings
• Prescribe DOAC to patients 18 years and older

Exclusion Criteria:

• Providers in inpatient settings
• Providers who are members of the study team

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New-prescription Alert / Existing-prescription notification to prescriber	Behavioral: 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.; Behavioral: 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.
Experimental: New-prescription Alert w/ referral option/ Existing-prescription notification to prescriber	Behavioral: 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.; Behavioral: 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.
Experimental: New-prescription Alert/ Existing-prescription notification to pharmacist	Behavioral: 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.; Behavioral: 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.
Experimental: New-prescription Alert w/ referral option/ Existing-prescription notification to pharmacist	Behavioral: 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number (Proportion) of Notifications (in the Existing-prescription Notification Conditions) That Are Addressed Within 7 Days.	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	Up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number (Proportion) of Alerts (in the Newly Prescribed DOAC Alert Conditions) That Are Addressed Within 7 Days.	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	Up to 7 days
Change in Effect Size for the Existing-prescription Notification Over Time	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.	Month 0 to 19 months
Change in Effect Size for the Initial Alert Over Time	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.	Month 0 to 19 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specific Prescription Related Adverse Events in Participants' Patients	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.	30 days from alert or notification

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Geoffrey Barnes, MD, University of Michigan

Publications and helpful links

General Publications

• Barnes GD, Choi SY, Lanham MS, Dorsch MP, Errickson J, Fabbri M, Saraswat A, Seagull FJ, Smith SN. Implementing prescriber-pharmacist collaboration to improve evidence-based medication prescribing using asynchronous, non-interruptive electronic health record notifications. Implement Sci. 2025 Dec 15;21(1):15. doi: 10.1186/s13012-025-01478-9.
• Smith SN, Lanham MSM, Seagull FJ, Fabbri M, Dorsch MP, Jennings K, Barnes G. System-Wide, Electronic Health Record-Based Medication Alerts for Appropriate Prescribing of Direct Oral Anticoagulants: Pilot Randomized Controlled Trial. JMIR Form Res. 2024 Nov 8;8:e64674. doi: 10.2196/64674.
• Smith SN, Lanham M, Seagull FJ, Dorsch M, Errickson J, Barnes GD. Implementing pharmacist-prescriber collaboration to improve evidence-based anticoagulant use: a randomized trial. Implement Sci. 2023 May 15;18(1):16. doi: 10.1186/s13012-023-01273-4.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): December 15, 2024

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Anticoagulation; Prescribing alerts
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Respiratory Tract Diseases; Arrhythmias, Cardiac; Lung Diseases; Embolism and Thrombosis; Embolism; Thromboembolism; Pathological Conditions, Signs and Symptoms; Pulmonary Embolism; Atrial Fibrillation; Venous Thromboembolism
• Other Study ID Numbers: HUM00207165; R18HS028562 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No