Anticoagulation With Enhanced Gastrointestinal Safety

Upper Gastrointestinal Bleeding Clinical Trial

— AEGIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05563714
• Other study ID #: HUM00217771
• Secondary ID: K23DK118179
• Status: Completed
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: January 4, 2023

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: January 4, 2023
• Est. primary completion date: January 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulant-induced Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Upper Gastrointestinal Bleeding

Intervention

Behavioral:
• Clinician Notification with Nurse Facilitation (CNNF)
An anticoagulation clinic nurse sends a templated message to the patient's target clinician that identifies the patient as high risk for upper GI bleeding, summarizes guidelines on appropriate antiplatelet medication use and PPI gastroprotection, and recommends that the clinician consider either discontinuing the patient's antiplatelet medication(s) or initiating a PPI for gastroprotection. The nurse will also offer to pend the order for a PPI if the clinician wants to initiate a PPI and will provide education to the patient on any medication changes recommended by the clinician.
• Wait list control
The anticoagulation clinic will not send the clinician notification letter or other project-specific materials to the clinician or patient, and the patient will be included on a list of patients who will receive the intervention at the conclusion of the trial.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ITT Analysis - Percent of Patients Reporting Medication Optimization	The percent of patients reporting medication optimization is defined as the number of patients who either discontinue all antiplatelet medications (none in the past 7 days) or initiate and adhere to a proton pump inhibitor (PPI) (use for at least 5 of the prior 7 days) based on self-report at week 7-10 divided by the total number of patients in that randomization arm.	Up to 10 weeks
Primary	Modified Completer Analysis - Percent of Patients Reporting Medication Optimization	The percent of patients reporting medication optimization is defined as the number of patients who either discontinue all antiplatelet medications (none in the past 7 days) or initiate and adhere to a proton pump inhibitor (PPI) (use for at least 5 of the prior 7 days) based on self-report at week 7-10 divided by the total number of patients in that randomization arm.	Up to 10 weeks
Secondary	ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation	The number of patients who have a recommendation from a Michigan Medicine clinician to either discontinue all antiplatelet medications or initiate a PPI divided by the total number of patients in that randomization arm.	Up to 10 weeks