Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF IV

NCT05236556 | Enrolling By Invitation

• 1 other identifier: HL155343
• Study Type: interventional
• Target: 5,094
• Locations: 1 country
• Sites: 2

Brief Summary

Six million Americans live with atrial fibrillation (AF), a heart rhythm abnormality that is a major risk factor for stroke and only half of those AF patients receive oral anticoagulation (AC). Within the context of an ongoing collaboration between two large learning health systems, the investigators propose to study the impact of a shared clinical decision support tool embedded within the electronic health record designed to enhance guideline-based AC prescription. The hypothesis the investigators are testing is that the number of AC starts in patients seen by intervention providers will be higher than in patients seen by control providers. Additionally, the investigators are testing the hypothesis that the risk of not persisting on AC will be higher in the patients of control providers compared with patients of intervention providers.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Initiation of Oral Anticoagulation (AC) Use

  The number of participants who initiate AC will be measured using the first encounter for each participant in the 12 months after randomization of providers and launch of the enhanced alert. To count as an AC initiation, a participant will have to have presence of an anticoagulant on his/her current medication list or an international normalized ratio (INR) lab value 1.5 or greater in the two months following the index encounter.

  12 months

• Length of Duration for Oral Anticoagulation (AC) Use

  The number of days participants continue on AC for one year after AC initiation will be tracked. Up to one month off AC such as for bleeding or surgical procedure will be permitted so long as the participant resumes AC prior to the end of the 12 month follow up.

  12 months

Secondary Outcomes (2)

• Hospitalization for new Stroke, Transient Ischemic Attack, or Systemic Embolism Ischemic Attack /Systemic Embolism.

  12 months

• Incidence of Major Hemorrhage and Clinically Relevant non-major Bleeding

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Receive best practice advisory (BPA)

Behavioral: Best practice advisory (BPA)

Control

NO INTERVENTION

Does not receive best practice advisory (BPA)

Interventions

Best practice advisory (BPA) BEHAVIORAL

For patients who are not on oral anticoagulation (AC) but have elevated stroke risk, the practice advisory will "fire," which is to say it will be active in the providers workflow during outpatient encounters with a patient's primary care provider (PCP) or cardiology provider.

Intervention

Eligibility Criteria

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

You may qualify if:

• Providers caring for patients aged 18 years and older with international classification of disease 10th revision (ICD-10) diagnostic code consistent with atrial fibrillation (AF) or atrial flutter who had a visit with a primary care provider or cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the electronic health record (EHR).
• Patients aged 18 years and older with ICD-10 diagnostic code consistent with AF or atrial flutter who had a visit with a primary care provider or cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the EHR.

You may not qualify if:

• Left atrial appendage closure
• Hospice status
• Providers who do not care for patients aged 18 years and older with ICD-10 diagnostic code consistent with AF or atrial flutter who had a visit with a primary care provider or cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the EHR.
• Patients under the age of 18; patients without a ICD-10 diagnostic code consistent with AF or atrial flutter who had a visit with a primary care provider or cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the EHR. Patients will also be excluded from this study if they are known to be pregnant or a prisoner.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• University of Florida: collaborator

Study Sites (2)

University of Florida College of Medicine - Jacksonville

Jacksonville, Florida, 32209, United States

Location

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alok Kapoor, MD

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: After removing providers who opted out, the investigators will randomize the remaining providers to either intervention or control in a 1:1 ratio, using randomly permuted blocks; randomization will be stratified jointly by provider type (cardiologist/primary care provider) and study site (University of Massachusetts/University of Florida). The allocation of the provider conducting the first visit for a patient will dictate the allocation for the patient.

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 11, 2022
• Study Start: December 15, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (2)