Anticoagulation With Enhanced Gastrointestinal Safety

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

341 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-05

Study Completion Date

2023-01-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Upper Gastrointestinal Bleeding Peptic Ulcer Hemorrhage Anticoagulant-induced Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

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.

Study Groups

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Clinician Notification with Nurse Facilitation (CNNF)

Group Type EXPERIMENTAL

Clinician Notification with Nurse Facilitation (CNNF)

Intervention Type 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 (Usual care)

Group Type OTHER

Wait list control

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No