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Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS)

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Clinician Notification with Nurse Facilitation (CNNF)

Wait list control

About this trial

This is an interventional health services research trial for Upper Gastrointestinal Bleeding focused on measuring Warfarin, Proton pump inhibitor, Antiplatelet therapy, Gastroprotection, Aspirin, Thienopyridine, Patient safety, Anticoagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Clinician Notification with Nurse Facilitation (CNNF)

Wait List Control (Usual care)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05563714

First Posted

September 28, 2022

Last Updated

January 4, 2023

Sponsor

University of Michigan

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05563714

Brief Title

Anticoagulation With Enhanced Gastrointestinal Safety

Acronym

AEGIS

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

October 5, 2022 (Actual)

Primary Completion Date

January 4, 2023 (Actual)

Study Completion Date

January 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

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.

Allocation

Randomized

Enrollment

341 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clinician Notification with Nurse Facilitation (CNNF)

Arm Type

Experimental

Arm Title

Wait List Control (Usual care)

Arm Type

Other

Intervention Type

Behavioral

Intervention Name(s)

Clinician Notification with Nurse Facilitation (CNNF)

Intervention Description

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

Intervention Name(s)

Wait list control

Intervention Description

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 Outcome Measure Information:

Title

Proportion of patients reporting medication optimization

Description

Time Frame

Up to 10 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Up to 10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacob E Kurlander, MD, MS

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Anticoagulation With Enhanced Gastrointestinal Safety

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