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

Primary Purpose

Upper Gastrointestinal Bleeding

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Clinician notification

Clinician Notification with Nurse Facilitation

Clinician Notification / Patient Activation

Clinician Notification with Nurse Facilitation / Patient Activation

About this trial

This is an interventional health services research trial for Upper Gastrointestinal Bleeding focused on measuring combination antithrombotic therapy, proton pump inhibitor, peptic ulcer disease, gastroprotection, warfarin, anticoagulation, patient safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Clinician Notification only

Clinician Notification with Nurse Facilitation only

Clinician Notification / Patient Activation

Clinician Notification with Nurse Facilitation / Patient Activation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05085405

First Posted

October 8, 2021

Last Updated

June 27, 2023

Sponsor

University of Michigan

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05085405

Brief Title

Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS) Trial

Acronym

AEGIS

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

October 11, 2021 (Actual)

Primary Completion Date

January 31, 2022 (Actual)

Study Completion Date

January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Upper Gastrointestinal Bleeding

Keywords

combination antithrombotic therapy, proton pump inhibitor, peptic ulcer disease, gastroprotection, warfarin, anticoagulation, patient safety

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Model Description

Assignment to one of two clinician-level implementation strategies will be done at the cluster level according to the identity of the clinician to be contacted. Clinicians will be randomized 1:1 to receive either clinician notification (CN) or clinician notification + nurse facilitation (CN+NF). Patients within each clinician cluster will also be individually randomized to receive a patient activation guide or to a usual care arm. There are 2 arms for each group (patients and clinicians).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clinician Notification only

Arm Type

Experimental

Arm Title

Clinician Notification with Nurse Facilitation only

Arm Type

Experimental

Arm Title

Clinician Notification / Patient Activation

Arm Type

Experimental

Arm Title

Clinician Notification with Nurse Facilitation / Patient Activation

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Clinician notification

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Clinician Notification with Nurse Facilitation

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Clinician Notification / Patient Activation

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Clinician Notification with Nurse Facilitation / Patient Activation

Intervention Description

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 Outcome Measure Information:

Title

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

Description

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

Time Frame

Week 5

Secondary Outcome Measure Information:

Title

Feasibility of Delivering Intervention Components as Intended

Description

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

Time Frame

week 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacob Kurlander, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35090577

Citation

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.

Results Reference

derived

Learn more about this trial

Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS) Trial

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