Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS) Trial

Not Applicable

Completed

• Conditions: Upper Gastrointestinal Bleeding
• Interventions: Behavioral: Clinician Notification / Patient Activation; Behavioral: Clinician notification; Behavioral: Clinician Notification with Nurse Facilitation; Behavioral: Clinician Notification with Nurse Facilitation / Patient Activation

• Registration Number: NCT05085405
• Lead Sponsor: University of Michigan

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-08
• Study First Submitted QC: 2021-10-08
• Study Start: 2021-10-11
• Study First Posted: 2021-10-20
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Results First Submitted: 2023-01-30
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-27
• Last Update Submitted: 2023-06-27
• Results First Posted: 2023-06-29
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Clinician Notification / Patient Activation	Clinician Notification / Patient Activation	-
Clinician Notification only	Clinician notification	-
Clinician Notification with Nurse Facilitation only	Clinician Notification with Nurse Facilitation	-
Clinician Notification with Nurse Facilitation / Patient Activation	Clinician Notification with Nurse Facilitation / Patient Activation	-

Primary Outcome Measures

Name	Time	Method
The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5	Week 5	The proportion of randomized patients that complete a brief medication review phone call at week 5 after up to 3 attempts.

Secondary Outcome Measures

Name	Time	Method
Feasibility of Delivering Intervention Components as Intended	week 1	The proportion of patient participants that received all implementation components to which they were randomized in the appropriate time frame.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States