IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation

NCT03259373 | Completed Results

• 1 other identifier: IMPACT-AFib
• Study Type: interventional
• Target: 64,666
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to use a decentralized claims database to determine whether education on stroke prevention in atrial fibrillation (AF) among AF patients and their providers can result in increased use of oral anticoagulants (OAC) for stroke prevention among those AF patients with guideline-based indications for oral anticoagulation (CHA₂DS₂-VASc score of 2 or greater). Specifically, the investigators will conduct a prospective, randomized, open-label education intervention trial to evaluate the effect of the early patient and provider education interventions on the proportion of patients with evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4 international normalized ratio \[INR tests\] over the course of the follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time). A total of approximately 80,000 patients will be enrolled within multiple major health plans across the United States. The randomization will be performed by the central coordinating center, and the health plans will mail the educational intervention materials to their members and providers.

Conditions

Atrial Fibrillation; Stroke

Keywords

AF; AFib; OAC; Atrial fibrillation; Oral anticoagulant; Education

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With Evidence of at Least One OAC Dispensing (Prescription Fill) (Defined as One OAC Dispensing or 4 INR (International Normalized Ratio) Tests)

  Evaluate the effect of the patient and provider education interventions (versus usual care with delayed provider education intervention) on the proportion of patients with evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4 INR tests) over the course of the 12 months of follow-up.

  Outcome assessed at 42 days, 90 days, 183 days, and one year of follow-up time.

Secondary Outcomes (12)

• Rates of Hospitalization for Ischemic or Unknown Stroke

  Outcome assessed at one year of follow-up time.

• Rates of Hospitalization for Hemorrhagic Stroke

  Outcome assessed at one year of follow-up time.

• Rates of Hospitalization for Ischemic or Hemorrhagic Stroke

  Outcome assessed at one year of follow-up time.

• Rates of Hospitalization for Ischemic or Hemorrhagic Stroke or Systemic Embolism

  Outcome assessed at one year of follow-up time.

• Rates of Hospitalization for Ischemic or Hemorrhagic Stroke or Systemic Embolism or Bleeding

  Outcome assessed at one year of follow-up time.

Study Arms (2)

Intervention

EXPERIMENTAL

Educational mailing to (1) AF patients with guideline-based indications for oral anticoagulation (CHA₂DS₂-VASc score of 2 or greater) who appear to not have received OAC treatment at time of randomization and (2) their providers, where an individual provider may be identified

Behavioral: Early Patient-Level and Provider-Level Educational Intervention

Control

EXPERIMENTAL

Educational mailing to providers of AF patients with guideline-based indications for oral anticoagulation (CHA₂DS₂-VASc score of 2 or greater) who appear to not have received OAC treatment in the time following randomization. These patients will have received 'usual care' for the time between randomization and delayed educational mailing.

Behavioral: Delayed Provider-Level Educational Intervention

Interventions

Early Patient-Level and Provider-Level Educational Intervention BEHAVIORAL

Letters to patients that (1) explain to the patient that he or she appears to have AF, characterize the risk of stroke, and emphasize that although there may be a medical reason, the patient does not seem to be on an anticoagulant and (2) encourage the patient to discuss this with his or her provider to ask if he or she might benefit from OAC therapy to prevent stroke. Early intervention letters to providers explain this project, the nature of the problem, and identify a list of the provider's patients who have been contacted, as the provider and patient letters will be sent at approximately the same time; describe evidence and guidelines regarding oral anticoagulation.

Intervention

Delayed Provider-Level Educational Intervention BEHAVIORAL

Delayed intervention letters to patients' providers, where they may be identified, that explain this project, the nature of the problem, and identify a list of their patients who are flagged as at risk for stroke and have not been treated with an oral anticoagulant; describe evidence and guidelines regarding oral anticoagulation.

Control

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Two or more diagnoses of AF (ICD-9 and/or 10 codes) at least one day apart and with at least one diagnosis within the last 12 months prior to the last date in the current approved data used for cohort identification
• CHA₂DS₂-VASc score of 2 or greater
• Medical and pharmacy insurance coverage of at least the prior year as identified via administrative claims databases of one of the participating data partners as of the date of randomization
• Age 30 years or greater as of the last date in the current approved data used for cohort identification

You may not qualify if:

• Evidence of OAC medication fill during the 12 months prior to randomization (determined at randomization for the early intervention cohort and 12 months post-randomization for the delayed intervention cohort)
• Conditions other than AF that require anticoagulation, including treatment of deep venous thrombosis, pulmonary embolism, or ever having had a mechanical prosthetic heart valve prior to the last date in the current approved data used for cohort identification
• Pregnancy within 6 months of the last date in the current approved data used for cohort identification
• Any known history of intracranial hemorrhage prior to the last date in the current approved data used for cohort identification
• Hospitalization for bleeding within the last 6 months of the last date in the current approved data used for cohort identification
• Patients with recent P2Y12 antagonist use (i.e. clopidogrel, prasugrel, ticlopidine, or ticagrelor within 90 days of the last date in the current approved data used for cohort identification

Sponsors & Collaborators

• Harvard Pilgrim Health Care: lead
• Duke Clinical Research Institute: collaborator
• Clinical Trials Transformation Initiative: collaborator
• Humana Inc.: collaborator
• Aetna, Inc.: collaborator
• OptumInsight Life Sciences, Inc.: collaborator
• Food and Drug Administration (FDA): collaborator

Study Sites (4)

Humana Healthcare Research, Inc.

Louisville, Kentucky, 40202, United States

Location

Harvard Pilgrim Health Care

Quincy, Massachusetts, 02169, United States

Location

OptumInsight, Inc

Waltham, Massachusetts, 02451, United States

Location

Aetna, Inc.

Blue Bell, Pennsylvania, 19422, United States

Location

Related Publications (2)

• Pokorney SD, Cocoros N, Al-Khalidi HR, Haynes K, Li S, Al-Khatib SM, Corrigan-Curay J, Driscoll MR, Garcia C, Calvert SB, Harkins T, Jin R, Knecht D, Levenson M, Lin ND, Martin D, McCall D, McMahill-Walraven C, Nair V, Parlett L, Petrone A, Temple R, Zhang R, Zhou Y, Platt R, Granger CB. Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2214321. doi: 10.1001/jamanetworkopen.2022.14321.

  PMID: 35639381 DERIVED

• Garcia CJ, Haynes K, Pokorney SD, Lin ND, McMahill-Walraven C, Nair V, Parlett L, Martin D, Al-Khalidi HR, McCall D, Granger CB, Platt R, Cocoros NM. Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial. Clin Trials. 2020 Aug;17(4):360-367. doi: 10.1177/1740774520928426. Epub 2020 Jun 26.

  PMID: 32589056 DERIVED

Related Links

• White Paper: Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database
• Sentinel Initiative IMPACT-AFib Project Page

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Results Point of Contact

• Title: Richard Platt, MD
• Organization: Harvard Pilgrim Health Care

Richard_Platt@harvardpilgrim.org

(617) 867-4912

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Department Chair

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: August 23, 2017
• Study Start: September 25, 2017
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2021
• Last Updated: April 9, 2025
• Results First Posted: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)