Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS)

University of Michigan

Status

Completed

Conditions

Peptic Ulcer Hemorrhage

Anticoagulant-induced Bleeding

Upper Gastrointestinal Bleeding

Treatments

Behavioral: Wait list control

Behavioral: Clinician Notification with Nurse Facilitation (CNNF)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05563714

K23DK118179 (U.S. NIH Grant/Contract)

HUM00217771

Details and patient eligibility

About

This study is a pragmatic cluster randomized controlled trial to evaluate the effectiveness of a clinician-facing implementation strategy on the use of medication optimization (defined as either discontinuation of all antiplatelet therapy or initiation of and adherence to a proton pump inhibitor (PPI)) to reduce upper GI bleeding risk in patients prescribed anticoagulant-antiplatelet therapy (AAT) relative to usual care.

Full description

This is a pragmatic, single-center cluster randomized controlled trial to evaluate a clinician-facing implementation strategy to increase the use of evidence-based practices (EBPs) to reduce bleeding in patients who are using AAT and who are managed by the Michigan Medicine anticoagulation monitoring service. The active intervention is clinician notification with nurse facilitation (CNNF), which consists of an anticoagulation clinic nurse sending an electronic health record message that identifies the patient as high risk for upper GI bleeding and recommends either discontinuing the antiplatelet agent or initiating a PPI; the nurse also pends medication orders for PPIs and provides patient education upon request. Clinicians will be cluster randomized, such that up to 4 patients cared for by each clinician will receive the same clinician-level notification.

This study will use a "wait-listed design," in which patients will be randomized to either have their clinicians receive CNNF or be included in a wait-list control group. At the completion of the study, the patients who were randomized to the wait-list control group will receive the intervention.

Enrollment

341 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Patients:

Enrollment with the Michigan Medicine anticoagulation monitoring service
Currently prescribed warfarin with anticipated use for ≥90 days on day 1 of trial enrollment, according to the electronic health record documentation.
Currently prescribed an antiplatelet medication (aspirin, clopidogrel, ticagrelor, or prasugrel) according to the electronic health record medication list

Inclusion Criteria for Clinicians:

Cardiologists at Michigan Medicine who in the prior year had a face-to-face or virtual visit with a patient who meets eligibility criteria
Michigan Medicine primary care providers for patients who meet eligibility criteria
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 Patients:

Age less than 18
Currently prescribed a PPI
Documented intolerance or allergy to PPI use
Left ventricular assist device
Heart transplant
Participation in a previous pilot study of these implementation strategies

Exclusion Criteria for Clinicians:

Cardiologists specializing in electrophysiology or who saw the patient for a clinic visit related to a TAVI procedure unless they are the clinician of record for a patient followed by the anticoagulation service who does not have a Michigan Medicine PCP.
Participation in a previous pilot study of these QI strategies