Clinical trial NCT05085405: Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS) Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Upper Gastrointestinal Bleeding
Keywords: combination antithrombotic therapy
proton pump inhibitor
peptic ulcer disease
gastroprotection
warfarin
anticoagulation
patient safety
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-10-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5
timeFrame: Week 5
Secondary outcomes:
measure: Feasibility of Delivering Intervention Components as Intended
timeFrame: week 1
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jacob Kurlander, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.