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

Study Overview
=================
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.

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

Conditions
-----------------
Pulmonary Embolism, Venous Thromboembolism, Atrial Fibrillation

Intervention / Treatment
-----------------
* Behavioral: New-prescription Alert
* Behavioral: New-prescription Alert with referral option
* Behavioral: Existing-prescription notification to prescriber
* Behavioral: Existing-prescription notification to pharmacist


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New-prescription Alert / Existing-prescription notification to prescriber<br> | Behavioral: New-prescription Alert<br>* 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.<br>Behavioral: Existing-prescription notification to prescriber<br>* 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.<br>|
| Experimental: New-prescription Alert w/ referral option/ Existing-prescription notification to prescriber<br> | Behavioral: New-prescription Alert with referral option<br>* 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.<br>Behavioral: Existing-prescription notification to prescriber<br>* 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.<br>|
| Experimental: New-prescription Alert/ Existing-prescription notification to pharmacist<br> | Behavioral: New-prescription Alert<br>* 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.<br>Behavioral: Existing-prescription notification to pharmacist<br>* 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.<br>|
| Experimental: New-prescription Alert w/ referral option/ Existing-prescription notification to pharmacist<br> | Behavioral: New-prescription Alert with referral option<br>* 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.<br>Behavioral: Existing-prescription notification to pharmacist<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prescribing alerts, Anticoagulation