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

Autor:	Pokorney SD; Duke Clinical Research Institute and Division of Cardiology, Duke University Medical Center, Durham, North Carolina., Cocoros N; Harvard Pilgrim Health Care Institute, Harvard Medical School Department of Population Medicine, Boston, Massachusetts., Al-Khalidi HR; Duke Clinical Research Institute and Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina., Haynes K; HealthCore Inc, Alexandria, Virginia., Li S; Duke Clinical Research Institute and Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina., Al-Khatib SM; Duke Clinical Research Institute and Division of Cardiology, Duke University Medical Center, Durham, North Carolina., Corrigan-Curay J; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Driscoll MR; Harvard Pilgrim Health Care Institute, Harvard Medical School Department of Population Medicine, Boston, Massachusetts., Garcia C; Harvard Pilgrim Health Care Institute, Harvard Medical School Department of Population Medicine, Boston, Massachusetts., Calvert SB; Clinical Trials Transformation Initiative, Durham, North Carolina., Harkins T; Humana Healthcare Research Inc, Louisville, Kentucky., Jin R; Harvard Pilgrim Health Care Institute, Harvard Medical School Department of Population Medicine, Boston, Massachusetts., Knecht D; Aetna Inc, Blue Bell, Pennsylvania., Levenson M; Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration., Lin ND; OptumInsight Life Sciences Inc, Boston, Massachusetts., Martin D; Moderna Inc, Cambridge, Massachusetts., McCall D; Rowan Tree Perspectives Consulting, Murrieta, California., McMahill-Walraven C; Aetna Inc, Blue Bell, Pennsylvania., Nair V; Humana Healthcare Research Inc, Louisville, Kentucky., Parlett L; HealthCore Inc, Alexandria, Virginia., Petrone A; Harvard Pilgrim Health Care Institute, Harvard Medical School Department of Population Medicine, Boston, Massachusetts., Temple R; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Zhang R; Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration., Zhou Y; Humana Healthcare Research Inc, Louisville, Kentucky., Platt R; Harvard Pilgrim Health Care Institute, Harvard Medical School Department of Population Medicine, Boston, Massachusetts., Granger CB; Duke Clinical Research Institute and Division of Cardiology, Duke University Medical Center, Durham, North Carolina.
Jazyk:	angličtina
Zdroj:	JAMA network open [JAMA Netw Open] 2022 May 02; Vol. 5 (5), pp. e2214321. Date of Electronic Publication: 2022 May 02.
DOI:	10.1001/jamanetworkopen.2022.14321
Abstrakt:	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.
Databáze:	MEDLINE
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