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

• Sponsor: University of Michigan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05351749
• Collaborator: Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
• Enrollment: 5,000
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 31
• Patients Per Site Per Month: 161.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Embolism; Venous Thromboembolism; Atrial Fibrillation	Behavioral: New-prescription Alert; Behavioral: New-prescription Alert with referral option; Behavioral: Existing-prescription notification to prescriber; Behavioral: Existing-prescription notification to pharmacist	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 5000 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Implementing Prescriber-Pharmacist Collaborative Care for Evidence-based Anticoagulant Use
• Actual Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

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: 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 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/ 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Geoffrey Barnes, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Geoffrey Barnes, Assistant Professor of Internal Medicine, University of Michigan
• ClinicalTrials.gov Identifier: NCT05351749
• Other Study ID Numbers: HUM00207165; R18HS028562
• First Posted: Apr 28, 2022
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Geoffrey Barnes, Assistant Professor of Internal Medicine, University of Michigan: Prescribing alerts; Anticoagulation
• Additional relevant MeSH terms: Pulmonary Embolism; Atrial Fibrillation; Embolism; Thromboembolism; Venous Thromboembolism

Study Results

No Results Posted as of Aug 5, 2022