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Completed

NCT Number: NCT05085405

Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS) Trial

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.

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Key information

Conditions

Upper Gastrointestinal Bleeding Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Clinician notification

Behavioral

An anticoagulation clinic nurse sends a templated letter to the patient's clinician and identifies the patient as high risk for upper GI bleeding, summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), provides a link to guidance on evidence-based use of antiplatelet therapy, and asks that the clinician manage any medication changes.

In this arm, patients receive no additional interventions beyond that provided during treatment as usual.

Clinician Notification with Nurse Facilitation

Behavioral

An anticoagulation clinic nurse sends an individualized letter to the patient's clinician which identifies the patient as high risk for upper GI bleeding and summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), but in addition includes a summary of the patient's history of atherosclerotic cardiovascular disease and a concise guidance summary on appropriate use of antiplatelet therapy for relevant indications. The anticoagulation nurse will assist with order entry for any new medications and also provide education on medication changes to the patient upon request by the clinician.

In this arm, patients receive no additional interventions beyond that provided during treatment as usual.

Clinician Notification / Patient Activation

Behavioral

An anticoagulation clinic nurse sends a templated letter to the patient's clinician and identifies the patient as high risk for upper GI bleeding, summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), provides a link to guidance on evidence-based use of antiplatelet therapy, and asks that the clinician manage any medication changes.

Patient Activation:

An anticoagulation clinic nurse sends the patient an 8-page written guide, either through the patient portal or by mail. The guide provides education on upper GI bleeding risk and encourages patients to talk with their clinician about medication changes to reduce their bleeding risk.

Clinician Notification with Nurse Facilitation / Patient Activation

Behavioral

An anticoagulation clinic nurse sends an individualized letter to the patient's clinician which identifies the patient as high risk for upper GI bleeding and summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), but in addition includes a summary of the patient's history of atherosclerotic cardiovascular disease and a concise guidance summary on appropriate use of antiplatelet therapy for relevant indications. The anticoagulation nurse will assist with order entry for any new medications and also provide education on medication changes to the patient upon request by the clinician.

Patient Activation:

An anticoagulation clinic nurse sends the patient an 8-page written guide, either through the patient portal or by mail. The guide provides education on upper GI bleeding risk and encourages patients to talk with their clinician about medication changes to reduce their bleeding risk.

Primary outcomes

  1. The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5

    Time frame: Week 5

    The proportion of randomized patients that complete a brief medication review phone call at week 5 after up to 3 attempts.

Secondary outcomes

  1. Feasibility of Delivering Intervention Components as Intended

    Time frame: week 1

    The proportion of patient participants that received all implementation components to which they were randomized in the appropriate time frame.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Department of Health and Human Services
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS): A Pilot Trial to Evaluate Clinician- and Patient-facing Strategies to Reduce Upper Gastrointestinal Bleeding Risk in Patients on Combination Antithrombotic Therapy

Acronym: AEGIS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 20, 2021
Registry last updated
Jun 29, 2023

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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