Skip to main content
OpenTrials
Completed

NCT Number: NCT05563714

Anticoagulation With Enhanced Gastrointestinal Safety

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Upper Gastrointestinal Bleeding Anticoagulant-induced Bleeding Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Hemorrhage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinician Notification with Nurse Facilitation (CNNF)

Behavioral

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

Behavioral

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.

Primary outcomes

  1. ITT Analysis - Percent of Patients Reporting Medication Optimization

    Time frame: Up to 10 weeks

    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.

  2. Modified Completer Analysis - Percent of Patients Reporting Medication Optimization

    Time frame: Up to 10 weeks

    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.

Secondary outcomes

  1. ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation

    Time frame: Up to 10 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study 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

Acronym: AEGIS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 3, 2022
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.