Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS) Trial

NCT05085405 | Completed Results

• 2 other identifiers: HUM00201535K23DK118179
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pragmatic, single center, feasibility pilot cluster randomized trial with embedded individual randomization to evaluate implementation strategies to increase the use of evidence-based practices to reduce upper gastrointestinal bleeding risk in patients using combination antithrombotic therapy (including warfarin) and that are managed by the Michigan Medicine anticoagulation monitoring service.

Conditions

Upper Gastrointestinal Bleeding

Keywords

combination antithrombotic therapy; proton pump inhibitor; peptic ulcer disease; gastroprotection; warfarin; anticoagulation; patient safety

Outcome Measures

Primary Outcomes (1)

• The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5

  The proportion of randomized patients that complete a brief medication review phone call at week 5 after up to 3 attempts.

  Week 5

Secondary Outcomes (1)

• Feasibility of Delivering Intervention Components as Intended

  week 1

Study Arms (4)

Clinician Notification only

EXPERIMENTAL

Behavioral: Clinician notification

Clinician Notification with Nurse Facilitation only

EXPERIMENTAL

Behavioral: Clinician Notification with Nurse Facilitation

Clinician Notification / Patient Activation

EXPERIMENTAL

Behavioral: Clinician Notification / Patient Activation

Clinician Notification with Nurse Facilitation / Patient Activation

EXPERIMENTAL

Behavioral: Clinician Notification with Nurse Facilitation / Patient Activation

Interventions

Clinician notification BEHAVIORAL

An anticoagulation clinic nurse sends a templated letter to the patient's clinician and identifies the patient as high risk for upper GI bleeding, summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), provides a link to guidance on evidence-based use of antiplatelet therapy, and asks that the clinician manage any medication changes. In this arm, patients receive no additional interventions beyond that provided during treatment as usual.

Clinician Notification only

Clinician Notification with Nurse Facilitation BEHAVIORAL

An anticoagulation clinic nurse sends an individualized letter to the patient's clinician which identifies the patient as high risk for upper GI bleeding and summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), but in addition includes a summary of the patient's history of atherosclerotic cardiovascular disease and a concise guidance summary on appropriate use of antiplatelet therapy for relevant indications. The anticoagulation nurse will assist with order entry for any new medications and also provide education on medication changes to the patient upon request by the clinician. In this arm, patients receive no additional interventions beyond that provided during treatment as usual.

Clinician Notification with Nurse Facilitation only

Clinician Notification / Patient Activation BEHAVIORAL

An anticoagulation clinic nurse sends a templated letter to the patient's clinician and identifies the patient as high risk for upper GI bleeding, summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), provides a link to guidance on evidence-based use of antiplatelet therapy, and asks that the clinician manage any medication changes. Patient Activation: An anticoagulation clinic nurse sends the patient an 8-page written guide, either through the patient portal or by mail. The guide provides education on upper GI bleeding risk and encourages patients to talk with their clinician about medication changes to reduce their bleeding risk.

Clinician Notification / Patient Activation

Clinician Notification with Nurse Facilitation / Patient Activation BEHAVIORAL

An anticoagulation clinic nurse sends an individualized letter to the patient's clinician which identifies the patient as high risk for upper GI bleeding and summarizes options for medication optimization (e.g., discontinuation of antiplatelet therapy or initiation of a proton pump inhibitor for gastroprotection), but in addition includes a summary of the patient's history of atherosclerotic cardiovascular disease and a concise guidance summary on appropriate use of antiplatelet therapy for relevant indications. The anticoagulation nurse will assist with order entry for any new medications and also provide education on medication changes to the patient upon request by the clinician. Patient Activation: An anticoagulation clinic nurse sends the patient an 8-page written guide, either through the patient portal or by mail. The guide provides education on upper GI bleeding risk and encourages patients to talk with their clinician about medication changes to reduce their bleeding risk.

Clinician Notification with Nurse Facilitation / Patient Activation

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 greater or equal to 90 days on day 1 of trial enrollment, according to electronic medical record documentation
• Currently prescribed an antiplatelet drug (aspirin, clopidogrel, ticagrelor, or prasugrel) according to the electronic medical record medication list

You may not qualify if:

• Prescribed a Proton Pump Inhibitor (PPI)
• Documented intolerance or allergy to PPI use
• Left ventricular assist device
• Heart transplant
• Practicing cardiologists at Michigan Medicine who in the prior year had a face-to-face or virtual visit with a patient who meets eligibility criteria for this study
• Practicing clinicians in any specialty who are designated as the clinician of record with the anticoagulation clinic for a patient who meets eligibility criteria
• \- Cardiologists specializing in electrophysiology unless they are the clinician of record for a patient followed by the anticoagulation service.

Sponsors & Collaborators

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

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Kurlander JE, Helminski D, Lanham M, Henstock JL, Kidwell KM, Krein SL, Saini SD, Richardson CR, De Vries R, Resnicow K, Ruff AL, Wallace DM, Jones EK, Perry LK, Parsons J, Ha N, Alexandris-Souphis T, Dedrick D, Aldridge E, Barnes GD. Development of a multicomponent implementation strategy to reduce upper gastrointestinal bleeding risk in patients using warfarin and antiplatelet therapy, and protocol for a pragmatic multilevel randomized factorial pilot implementation trial. Implement Sci Commun. 2022 Jan 28;3(1):8. doi: 10.1186/s43058-022-00256-8.

  PMID: 35090577 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Peptic Ulcer

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

jkurland@umich.edu

734-647-9252

Study Officials

• Jacob Kurlander, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Model Details: Assignment to one of two clinician-level implementation strategies will be done at the cluster level according to the identity of the clinician to be contacted. Clinicians will be randomized 1:1 to receive either clinician notification (CN) or clinician notification + nurse facilitation (CN+NF). Patients within each clinician cluster will also be individually randomized to receive a patient activation guide or to a usual care arm. There are 2 arms for each group (patients and clinicians).

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 20, 2021
• Study Start: October 11, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: June 29, 2023
• Results First Posted: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)