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

Primary Purpose

Pulmonary Embolism, Venous Thromboembolism, Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
New-prescription Alert
New-prescription Alert with referral option
Existing-prescription notification to prescriber
Existing-prescription notification to pharmacist
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pulmonary Embolism focused on measuring Prescribing alerts, Anticoagulation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

New-prescription Alert / Existing-prescription notification to prescriber

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

New-prescription Alert/ Existing-prescription notification to pharmacist

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

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
April 6, 2022
Last Updated
September 5, 2023
Sponsor
University of Michigan
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT05351749
Brief Title
Implementing Prescriber-Pharmacist Collaborative Care for Evidence-based Anticoagulant Use
Official Title
Implementing Prescriber-Pharmacist Collaborative Care for Evidence-based Anticoagulant Use
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Venous Thromboembolism, Atrial Fibrillation
Keywords
Prescribing alerts, Anticoagulation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
New-prescription Alert / Existing-prescription notification to prescriber
Arm Type
Experimental
Arm Title
New-prescription Alert w/ referral option/ Existing-prescription notification to prescriber
Arm Type
Experimental
Arm Title
New-prescription Alert/ Existing-prescription notification to pharmacist
Arm Type
Experimental
Arm Title
New-prescription Alert w/ referral option/ Existing-prescription notification to pharmacist
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
New-prescription Alert
Intervention Description
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
Intervention Name(s)
New-prescription Alert with referral option
Intervention Description
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
Intervention Name(s)
Existing-prescription notification to prescriber
Intervention Description
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
Intervention Name(s)
Existing-prescription notification to pharmacist
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number (proportion) of notifications (in the existing-prescription notification conditions) that are addressed within 7 days.
Description
Existing-prescription notification conditions = Prescriber notification & Pharmacist notification
Time Frame
Up to 7 days
Secondary Outcome Measure Information:
Title
The number (proportion) of alerts (in the newly prescribed DOAC alert conditions) that are addressed within 7 days.
Description
Newly prescribed DOAC alert conditions= Medication alert & Medication alert + referral
Time Frame
Up to 7 days
Title
Change in effect size for the existing-prescription notification over time
Description
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.
Time Frame
Month 0, Up to 18 months
Title
Change in effect size for the initial alert over time
Description
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.
Time Frame
Month 0, Up to 18 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jake Seagull, PhD
Phone
734-615-8377
Email
jseagull@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey Barnes, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jake Seagull, PhD
Phone
734-615-8377
Email
jseagull@umich.edu
First Name & Middle Initial & Last Name & Degree
Geoffrey Barnes, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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