Anticoagulation With Enhanced Gastrointestinal Safety (NCT05563714) | Clinical Trial Compass
CompletedNot Applicable
Anticoagulation With Enhanced Gastrointestinal Safety
United States341 participantsStarted 2022-10-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
ITT Analysis - Percent of Patients Reporting Medication Optimization
Timeframe: Up to 10 weeks
2
Modified Completer Analysis - Percent of Patients Reporting Medication Optimization