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OpenTrials
Completed

NCT Number: NCT05351749

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

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

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Key information

About this study

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 data was obtained through data downloads and not from individual participant interactions. Final data collection for all outcomes took place on Dec 15, 2024.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

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.

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.

Primary outcomes

  1. The Number (Proportion) of Notifications (in the Existing-prescription Notification Conditions) That Are Addressed Within 7 Days.

    Time frame: Up to 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

Secondary outcomes

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

    Time frame: Up to 7 days

    Newly prescribed DOAC alert conditions= Medication alert & Medication alert + referral

    Data reported represents the number of alerts (in the newly prescribed DOAC alert conditions) that are addressed within 7 days/ total number of alerts

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

    Time frame: Month 0 to 19 months

    Reported on at the institution level (not individual level). 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, shown over multiple time periods.

    This outcome measure analysis is based on the results of outcome #1.

  3. Change in Effect Size for the Initial Alert Over Time

    Time frame: Month 0 to 19 months

    Reported on at the institution level (not individual level). Newly prescribed DOAC alert condition= Medication alert & Medication alert + referral

    The number of new prescription alerts that are addressed within 7 days/ total number of alerts, shown over multiple time periods.

    This outcome measure analysis is based on the results of outcome #2.

Other outcomes

  1. Specific Prescription Related Adverse Events in Participants' Patients

    Time frame: 30 days from alert or notification

    Data was gathered from the patients of participants within 30 days of a notification being sent via post-hoc examination of electronic medical record data

    Clinical adverse events assessed will include major 21 and clinically-relevant non-major bleeding (CRNMB)22 events, as defined by the International Society on Thrombosis and Haemostasis (ISTH), new or recurrent VTE events, and stroke or systemic arterial embolic events. Each of these events will be captured using health informatics tools (described below) and independently adjudicated by two expert clinicians (one pharmacist, one prescriber) who meet once in Y1 and twice in Y2 to adjudicate any potential adverse events. We will use two Michigan Medicine-developed health informatics tools, DataDirect and EMERSE,23 to identify adverse events and capture clinical data (e.g., notes, labs, imaging, procedure reports) for adjudication.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 28, 2022
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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