Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS) Trial

University of Michigan

Status: Completed

Conditions: Upper Gastrointestinal Bleeding

Treatments: Behavioral: Clinician notification; Behavioral: Clinician Notification with Nurse Facilitation / Patient Activation; Behavioral: Clinician Notification with Nurse Facilitation; Behavioral: Clinician Notification / Patient Activation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT05085405

K23DK118179 (U.S. NIH Grant/Contract)

HUM00201535

Details and patient eligibility

About

This is a pragmatic, single center, feasibility pilot cluster randomized trial with embedded individual randomization to evaluate implementation strategies to increase the use of evidence-based practices to reduce upper gastrointestinal bleeding risk in patients using combination antithrombotic therapy (including warfarin) and that are managed by the Michigan Medicine anticoagulation monitoring service.

Full description

In February 2022, the IRB approved adding a small additional substudy for the collection of exploratory qualitative outcomes only, involving up to 8 primary care physicians. As no data for the primary and secondary outcome measures was collected for this substudy, and all data collection for this group was related to exploratory outcome measures and collected through qualitative interviews with clinicians, no inclusion exclusion criteria specific to the participants in this substudy are listed, nor does the data collection from them show in the study completion date or results data. However, these physicians (n=8) and their patients (n=9) are counted in the actual enrollment total since they were randomized to intervention arms and received study interventions.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Patients:

• Enrollment with the Michigan Medicine anticoagulation monitoring service
• Currently prescribed warfarin with anticipated use for greater or equal to 90 days on day 1 of trial enrollment, according to electronic medical record documentation
• Currently prescribed an antiplatelet drug (aspirin, clopidogrel, ticagrelor, or prasugrel) according to the electronic medical record medication list

Exclusion Criteria for Patients:

• Prescribed a Proton Pump Inhibitor (PPI)
• Documented intolerance or allergy to PPI use
• Left ventricular assist device
• Heart transplant

Inclusion Criteria for Clinicians:

• Practicing cardiologists at Michigan Medicine who in the prior year had a face-to-face or virtual visit with a patient who meets eligibility criteria for this study
• Practicing clinicians in any specialty who are designated as the clinician of record with the anticoagulation clinic for a patient who meets eligibility criteria

Exclusion Criteria for Clinicians:

• Cardiologists specializing in electrophysiology unless they are the clinician of record for a patient followed by the anticoagulation service.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Clinician Notification only

Experimental group

Treatment:

Behavioral: Clinician notification

Clinician Notification with Nurse Facilitation only

Experimental group

Treatment:

Behavioral: Clinician Notification with Nurse Facilitation

Clinician Notification / Patient Activation

Experimental group

Treatment:

Behavioral: Clinician Notification / Patient Activation

Clinician Notification with Nurse Facilitation / Patient Activation

Experimental group

Treatment:

Behavioral: Clinician Notification with Nurse Facilitation / Patient Activation