Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants: A Randomized Clinical Trial

Abstract

Importance: Only about half of patients with atrial fibrillation (AF) who are at increased risk for stroke are treated with an oral anticoagulant (OAC), despite guideline recommendations for their use. Educating patients with AF about prevention of stroke with OACs may enable them as agents of change to initiate OAC treatment.

Objective: To determine whether an educational intervention directed to patients and their clinicians stimulates the use of OACs in patients with AF who are not receiving OACs.

Design, setting, and participants: The Implementation of a Randomized Controlled Trial to Improve Treatment With Oral Anticoagulants in Patients With Atrial Fibrillation (IMPACT-AFib) trial was a prospective, multicenter, open-label, pragmatic randomized clinical trial conducted from September 25, 2017, to May 1, 2019, embedded in health plans that participate in the US Food and Drug Administration's Sentinel System. It used the distributed database comprising health plan members to identify eligible patients, their clinicians, and outcomes. IMPACT-AFib enrolled patients with AF, a CHA2DS2-VASc (cardiac failure or dysfunction, hypertension, age 65-74 [1 point] or ≥75 years [2 points], diabetes, and stroke, transient ischemic attack or thromboembolism [2 points]-vascular disease, and sex category [female]) score of 2 or more, no evidence of OAC prescription dispensing in the preceding 12 months, and no hospitalization-related bleeding event within the prior 6 months.

Interventions: Randomization to a single mailing of patient and/or clinician educational materials vs control.

Main outcomes and measures: Analysis was performed on a modified intention-to-treat basis. The primary end point was the proportion of patients with at least 1 OAC prescription dispensed or at least 4 international normalized ratio test results within 1 year of the intervention.

Results: Among 47 333 patients, there were 24 909 men (52.6%), the mean (SD) age was 77.9 (9.7) years, mean (SD) CHA2DS2-VASc score was 4.5 (1.7), 22 404 patients (47.3%) had an ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation) bleeding risk score of 5 or more, and 8890 patients (18.8%) had a history of hospitalization for bleeding. There were 2328 of 23 546 patients (9.9%) in the intervention group with initiation of OAC at 1 year compared with 2330 of 23 787 patients (9.8%) in the control group (adjusted OR, 1.01 [95% CI, 0.95-1.07]; P = .79).

Conclusions and relevance: Among a large population with AF with a guideline indication for OACs for stroke prevention who were randomized to a mailed educational intervention or to usual care, there was no clinically meaningful, numerical, or statistically significant difference in rates of OAC initiation. More-intensive interventions are needed to try and address the public health issue of underuse of anticoagulation for stroke prevention among patients with AF.

Trial registration: ClinicalTrials.gov Identifier: NCT03259373.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Pokorney reported receiving grants from the US Food and Drug Administration (FDA) during the conduct of the study; grants and personal fees from Bristol Myers Squibb, Pfizer, Janssen Pharmaceuticals, and Boston Scientific; and personal fees from Medtronic, Philips, and Zoll outside the submitted work. Dr Cocoros reported receiving grants from the FDA during the conduct of the study. Dr Al-Khalidi reported receiving grants from the FDA during the conduct of the study; and personal fees from Medpace Inc and CSL Behring outside the submitted work. Dr Haynes reported receiving grants from the FDA during the conduct of the study; and grants from Janssen Pharmaceuticals outside the submitted work. Ms Driscoll reported receiving grants from the FDA during the conduct of the study. Mrs Garcia reported receiving grants from the FDA during the conduct of the study. Dr Calvert reported receiving grants from the FDA during the conduct of the study; and grants and membership fees from Clinical Trials Transformation Initiative outside the submitted work. Dr Knecht reported being employed by CVS Health outside the submitted work. Dr Lin reported receiving grants from the FDA during the conduct of the study. Dr Martin reported receiving grants from the FDA during the conduct of the study. Dr McMahill-Walraven reported receiving grants from Harvard Pilgrim Health Care Institute during the conduct of the study; and working for CVS Health Clinical Trial Services LLC, an affiliate of CVS Health (she is responsible for CVS Health Clinical Trial Services LLC activities with the FDA Sentinel Initiative, including both the Sentinel Program and BEST Program, and other Distributed Research Networks [DRNs] that use Sentinel Infrastructure to analyze health claims data administered by Aetna, also a CVS Health affiliate; the DRNs include Academy of Managed Care Pharmacy’s Biologics and Biosimilars Collective Intelligence Collaborative; Reagan-Udall’s Foundation IMEDS multisite research service agreements funded by Abbvie, Merck, Novartis, and Pfizer; the Patient-Centered Outcomes Research Institute; Research Action for Health Network; TherapeuticsMD; National Evaluation System for Health Technology Coordinating Center; and Harvard Pilgrim Health Care Institute multisite research subcontracts funded by the FDA, National Institutes of Health, Pfizer, Janssen Pharmaceuticals, and GSK). Dr Parlett reported receiving grants from Harvard Pilgrim Health Care Institute during the conduct of the study. Ms Zhou reported receiving grants from Harvard Pilgrim during the conduct of the study. Dr Platt reported receiving grants from the FDA during the conduct of the study. Dr Granger reported receiving grants from the FDA during the conduct of the study; and personal fees from Boehringer Ingelheim, Daiichi Sankyo, Bayer, Janssen Pharmaceuticals, Boston Scientific, Bristol Myers Squibb, and Pfizer outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. Flow Diagram of Primary Analysis Population

aReasons for censoring: evidence of oral anticoagulant (OAC) treatment prior to start date based on more complete data, disenrolled earlier than originally captured in data (owing to changing in data over time), not able to be included in research owing to type of health plan, or request not to be contacted for research.

Figure 2.. Primary Outcome Results

Primary outcome of oral anticoagulant (OAC) initiation at 1 year, 183 days, 90 days, and 42 days with modified intention to treat for the primary analysis of 4 data partners. The forest plot for the odds ratios (ORs) is displayed on a log scale using a logarithmic axis. INR indicates international normalized ratio.

Figure 3.. Subgroup Analysis

Primary outcome of oral anticoagulant initiation at 1 year with modified intention to treat across prespecified subgroups for the primary analysis of 4 sites. The forest plot for the odds ratios (ORs) is displayed on a log scale using a logarithmic axis. CHA2DS2-VASc indicates cardiac failure or dysfunction, hypertension, age 65-74 (1 point) or ≥75 years (2 points), diabetes, and stroke, transient ischemic attack or thromboembolism (2 points)–vascular disease, and sex category (female). aMeta-analysis data were used from 4 data partners.

Figure 4.. Secondary Clinical Outcomes Analysis

Secondary clinical outcomes at 1 year with the modified intention-to-treat population from 4 sites. The forest plot for the hazard ratios (HRs) is displayed on a log scale using a logarithmic axis. aMeta-analysis data were used from 4 data partners. bMeta-analysis data were used from 3 data partners.