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

NCT ID: NCT05351749

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2026-01-31

Brief Summary

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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

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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.

Conditions

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Pulmonary Embolism Venous Thromboembolism Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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New-prescription Alert / Existing-prescription notification to prescriber

Group Type EXPERIMENTAL

New-prescription Alert

Intervention Type 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.

Existing-prescription notification to prescriber

Intervention Type 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 w/ referral option/ Existing-prescription notification to prescriber

Group Type EXPERIMENTAL

New-prescription Alert with referral option

Intervention Type 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.

Existing-prescription notification to prescriber

Intervention Type 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 pharmacist

Group Type EXPERIMENTAL

New-prescription Alert

Intervention Type 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.

Existing-prescription notification to pharmacist

Intervention Type 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

Group Type EXPERIMENTAL

New-prescription Alert with referral option

Intervention Type 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.

Existing-prescription notification to pharmacist

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Geoffrey Barnes

Assistant Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Geoffrey Barnes, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39514247 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37189171 (View on PubMed)

Other Identifiers

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R18HS028562

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

HUM00207165

Identifier Type: -

Identifier Source: org_study_id

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