Anticoagulation With Enhanced Gastrointestinal Safety

NCT05563714 | Completed Results

• 2 other identifiers: HUM00217771K23DK118179
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Warfarin; Proton pump inhibitor; Antiplatelet therapy; Gastroprotection; Aspirin; Thienopyridine; Patient safety; Anticoagulation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

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

  Up to 10 weeks

Study Arms (2)

Clinician Notification with Nurse Facilitation (CNNF)

EXPERIMENTAL

Behavioral: Clinician Notification with Nurse Facilitation (CNNF)

Wait List Control (Usual care)

OTHER

Behavioral: Wait list control

Interventions

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.

Clinician Notification with Nurse Facilitation (CNNF)

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.

Wait List Control (Usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Peptic Ulcer Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jacob E. Kurlander, MD, MS
• Organization: University of Michigan

jkurland@umich.edu

734-660-4883

Study Officials

• Jacob E Kurlander, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Neither patients, clinicians, or anticoagulation staff can practically be blinded. We will attempt to blind the research staff who are making patient calls at week 7-10 to the randomization group of the patient by not providing them with any information that would allow them to infer the randomization group, by not having them enter the electronic health record for the patients, where such information could be obtained, and by excluding any information from the call script that might help identify the randomization group. However, if due to staffing or personnel issues, blinded research staff are unable to complete all patient calls within the specified time frame, unblinded research staff will assist with completing patient calls.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Model Details: Randomization (1:1) of clinicians and patients to CNNF vs. wait list control will be done at the cluster level according to the identity of the clinician to be contacted. Clinician randomization will be stratified by number of eligible patients, and by procedural vs. non-procedural specialty. Randomization will be carried out by the study statistician. For each included clinician, up to 4 patients will be included in their cluster. If a clinician is selected to participate who has more than 4 eligible patients, 4 of their patients will be randomly selected to participate.

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 3, 2022
• Study Start: October 5, 2022
• Primary Completion: January 4, 2023
• Study Completion: January 4, 2023
• Last Updated: April 30, 2024
• Results First Posted: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)