N/A
N=63
Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS) Trial
Upper Gastrointestinal Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT05085405 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5 — 7; 12; 8; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Clinician notification (Behavioral); Clinician Notification with Nurse Facilitation (Behavioral); Clinician Notification / Patient Activation (Behavioral); Clinician Notification with Nurse Facilitation / Patient Activation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5 |
7; 12; 8; 8 | — |
| SECONDARY Feasibility of Delivering Intervention Components as Intended |
13; 13; 11; 10 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT05085405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.