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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05351749
• Other study ID #: HUM00207165
• Secondary ID: R18HS028562
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: January 2026

Study information

• Verified date: September 2023
• Source: University of Michigan
• Contact: Jake Seagull, PhD
• Phone: 734-615-8377
• Email: jseagull[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: January 2026
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Venous Thromboembolism

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 7 days
Secondary	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	Up to 7 days
Secondary	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; This outcome measure analysis is based on the results of outcome #1.	Month 0, Up to 18 months
Secondary	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; This outcome measure analysis is based on the results of outcome #2.	Month 0, Up to 18 months