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

Not Applicable

Active, not recruiting

• Conditions: Venous Thromboembolism; Pulmonary Embolism; Atrial Fibrillation
• Interventions: Behavioral: New-prescription Alert; Behavioral: New-prescription Alert with referral option; Behavioral: Existing-prescription notification to prescriber; Behavioral: Existing-prescription notification to pharmacist

• Registration Number: NCT05351749
• Lead Sponsor: University of Michigan

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-04-28
• Study Start: 2022-08-01
• Primary Completion: 2024-12-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 306

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
New-prescription Alert / Existing-prescription notification to prescriber	New-prescription Alert	-
New-prescription Alert/ Existing-prescription notification to pharmacist	New-prescription Alert	-
New-prescription Alert w/ referral option/ Existing-prescription notification to pharmacist	New-prescription Alert with referral option	-
New-prescription Alert w/ referral option/ Existing-prescription notification to prescriber	New-prescription Alert with referral option	-
New-prescription Alert / Existing-prescription notification to prescriber	Existing-prescription notification to prescriber	-
New-prescription Alert w/ referral option/ Existing-prescription notification to prescriber	Existing-prescription notification to prescriber	-
New-prescription Alert/ Existing-prescription notification to pharmacist	Existing-prescription notification to pharmacist	-
New-prescription Alert w/ referral option/ Existing-prescription notification to pharmacist	Existing-prescription notification to pharmacist	-

Primary Outcome Measures

Name	Time	Method
The number (proportion) of notifications (in the existing-prescription notification conditions) that are addressed within 7 days.	Up to 7 days	Existing-prescription notification conditions = Prescriber notification \& Pharmacist notification

Secondary Outcome Measures

Name	Time	Method
The number (proportion) of alerts (in the newly prescribed DOAC alert conditions) that are addressed within 7 days.	Up to 7 days	Newly prescribed DOAC alert conditions= Medication alert \& Medication alert + referral
Change in effect size for the initial alert over time	Month 0, Up to 18 months	Reported on at the institution level (not individual level). Newly prescribed DOAC alert condition= Medication alert \& Medication alert + referral; This outcome measure analysis is based on the results of outcome #2.
Change in effect size for the existing-prescription notification over time	Month 0, Up to 18 months	Reported on at the institution level (not individual level). Existing-prescription notification conditions = Prescriber notification \& Pharmacist notification; This outcome measure analysis is based on the results of outcome #1.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States