Clinical trial NCT05563714: Anticoagulation With Enhanced Gastrointestinal Safety
Official title: Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS): A Pragmatic Randomized Trial to Evaluate Clinician Outreach to Reduce Upper Gastrointestinal Bleeding Risk in Patients Taking Warfarin and Antiplatelet Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Gastrointestinal Bleeding
Peptic Ulcer Hemorrhage
Anticoagulant-induced Bleeding
Keywords: Warfarin
Proton pump inhibitor
Antiplatelet therapy
Gastroprotection
Aspirin
Thienopyridine
Patient safety
Anticoagulation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-10-03
Enrollment: 341
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization (1:1) of clinicians and patients to CNNF vs. wait list control will be done at the cluster level according to the identity of the clinician to be contacted. Clinician randomization will be stratified by number of eligible patients, and by procedural vs. non-procedural specialty. Randomization will be carried out by the study statistician. For each included clinician, up to 4 patients will be included in their cluster. If a clinician is selected to participate who has more than 4 eligible patients, 4 of their patients will be randomly selected to participate.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: ITT Analysis - Percent of Patients Reporting Medication Optimization
timeFrame: Up to 10 weeks
measure: Modified Completer Analysis - Percent of Patients Reporting Medication Optimization
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jacob E Kurlander, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: