AEGIS: Anticoagulation With Enhanced Gastrointestinal Safety

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT05563714

Collaborator

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

341

Enrollment

Location

Arms

Actual Duration (Months)

114.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Gastrointestinal Bleeding Peptic Ulcer Hemorrhage Anticoagulant-induced Bleeding	Behavioral: Clinician Notification with Nurse Facilitation (CNNF) Behavioral: Wait list control	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

341 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Health Services Research

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

Actual Study Start Date :

Oct 5, 2022

Actual Primary Completion Date :

Jan 4, 2023

Actual Study Completion Date :

Jan 4, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Proportion of patients reporting medication optimization [Up to 10 weeks]
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.

Secondary Outcome Measures

Proportion of patients with documented recommendation regarding antiplatelet therapy cessation or PPI initiation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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