Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Peptic Ulcer Hemorrhage; Upper Gastrointestinal Bleeding; Anticoagulant-induced Bleeding
• Intervention / Treatment: Behavioral: Clinician Notification with Nurse Facilitation (CNNF); Behavioral: Wait list control

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 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.

• Study Type: Interventional
• Enrollment (Actual): 341
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinician Notification with Nurse Facilitation (CNNF)	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.
Other: Wait List Control (Usual care)	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients reporting medication optimization	The proportion 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion 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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Jacob E Kurlander, MD, MS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Actual): January 4, 2023
• Study Completion (Actual): January 4, 2023

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Aspirin; Anticoagulation; Patient safety; Warfarin; Antiplatelet therapy; Proton pump inhibitor; Gastroprotection; Thienopyridine
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Hemorrhage; Peptic Ulcer; Gastrointestinal Hemorrhage; Peptic Ulcer Hemorrhage
• Other Study ID Numbers: HUM00217771; K23DK118179 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No