Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS) Trial (AEGIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Upper Gastrointestinal Bleeding
• Intervention / Treatment: Behavioral: Clinician notification; Behavioral: Clinician Notification with Nurse Facilitation; Behavioral: Clinician Notification / Patient Activation; Behavioral: Clinician Notification with Nurse Facilitation / Patient Activation

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinician Notification only	Behavioral: Clinician notification; 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.
Experimental: Clinician Notification with Nurse Facilitation only	Behavioral: Clinician Notification with Nurse Facilitation; 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.
Experimental: Clinician Notification / Patient Activation	Behavioral: Clinician Notification / Patient Activation; 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.
Experimental: Clinician Notification with Nurse Facilitation / Patient Activation	Behavioral: Clinician Notification with Nurse Facilitation / Patient Activation; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Department of Health and Human Services
• Investigators: Principal Investigator: Jacob Kurlander, MD, University of Michigan

Publications and helpful links

General Publications

• Kurlander JE, Helminski D, Lanham M, Henstock JL, Kidwell KM, Krein SL, Saini SD, Richardson CR, De Vries R, Resnicow K, Ruff AL, Wallace DM, Jones EK, Perry LK, Parsons J, Ha N, Alexandris-Souphis T, Dedrick D, Aldridge E, Barnes GD. Development of a multicomponent implementation strategy to reduce upper gastrointestinal bleeding risk in patients using warfarin and antiplatelet therapy, and protocol for a pragmatic multilevel randomized factorial pilot implementation trial. Implement Sci Commun. 2022 Jan 28;3(1):8. doi: 10.1186/s43058-022-00256-8.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: warfarin; anticoagulation; proton pump inhibitor; patient safety; peptic ulcer disease; combination antithrombotic therapy; gastroprotection
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: HUM00201535; K23DK118179 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No