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

NCT05351749 | Completed Results DMC

• 2 other identifiers: HUM00207165R18HS028562
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Embolism; Venous Thromboembolism; Atrial Fibrillation

Keywords

Prescribing alerts; Anticoagulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The Number (Proportion) of Alerts (in the Newly Prescribed DOAC Alert Conditions) That Are Addressed Within 7 Days.

  Up to 7 days

• Change in Effect Size for the Existing-prescription Notification Over Time

  Month 0 to 19 months

• Change in Effect Size for the Initial Alert Over Time

  Month 0 to 19 months

Other Outcomes (1)

• Specific Prescription Related Adverse Events in Participants' Patients

  30 days from alert or notification

Study Arms (4)

New-prescription Alert / Existing-prescription notification to prescriber

EXPERIMENTAL

Behavioral: New-prescription Alert; Behavioral: Existing-prescription notification to prescriber

New-prescription Alert w/ referral option/ Existing-prescription notification to prescriber

EXPERIMENTAL

Behavioral: New-prescription Alert with referral option; Behavioral: Existing-prescription notification to prescriber

New-prescription Alert/ Existing-prescription notification to pharmacist

EXPERIMENTAL

Behavioral: New-prescription Alert; Behavioral: Existing-prescription notification to pharmacist

New-prescription Alert w/ referral option/ Existing-prescription notification to pharmacist

EXPERIMENTAL

Behavioral: New-prescription Alert with referral option; Behavioral: Existing-prescription notification to pharmacist

Interventions

Existing-prescription notification to pharmacist BEHAVIORAL

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 w/ referral option/ Existing-prescription notification to pharmacist; New-prescription Alert/ Existing-prescription notification to pharmacist

New-prescription Alert BEHAVIORAL

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.

New-prescription Alert / Existing-prescription notification to prescriber; New-prescription Alert/ Existing-prescription notification to pharmacist

New-prescription Alert with referral option BEHAVIORAL

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.

New-prescription Alert w/ referral option/ Existing-prescription notification to pharmacist; New-prescription Alert w/ referral option/ Existing-prescription notification to prescriber

Existing-prescription notification to prescriber BEHAVIORAL

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 / Existing-prescription notification to prescriber; New-prescription Alert w/ referral option/ Existing-prescription notification to prescriber

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (3)

• 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.

  PMID: 41398697 DERIVED

• 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.

  PMID: 39514247 DERIVED

• 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.

  PMID: 37189171 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thromboembolism; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Geoffrey Barnes, MD, MSc
• Organization: University of Michigan

gbarnes@med.umich.edu

888-287-1082

Study Officials

• Geoffrey Barnes, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 28, 2022
• Study Start: August 1, 2022
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: March 30, 2026
• Results First Posted: March 30, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)