Storytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation

Официальное название

Storytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation Randomized Trial (STORY-AF Trial)

Обзор

The overall goal of this study is to evaluate the effectiveness of a previously developed storytelling intervention on anticoagulation (AC) initiation/persistence in African American and Black patients with atrial fibrillation/flutter. The investigators hope to gain knowledge that may help treat atrial fibrillation or flutter and lower stroke and adverse cardiovascular event risks for African American and Black patients by increasing the use of blood thinning medications known as anticoagulants.

Подробное описание

This is a multi-site research study including sites of both the University of Massachusetts Chan Medical School (UMass Memorial Healthcare System) and the University of Michigan Medical Center (Michigan).

Baseline call: During the baseline call, the investigators will obtain verbal informed consent. During the call, the investigators will also collect demographic information and measure health literacy, the latter using two validated single-item instruments the investigators have used before.

Randomization: The investigators will randomize patients to watch videos the investigators developed (intervention) versus informational videos (controls). More specifically, the investigators will randomize patients separately by study site (UMass/Michigan), using randomly permuted blocks of sizes 4 and 6 embedded into a prespecified table.

Exit interview: The exit interview will be conducted approximately 90 days from the date of enrollment with study participants. Interview questions will relate to whether the patient has already started AC, the likelihood of starting anticoagulation (AC), barriers to starting AC, and burdensomeness and acceptability of the interview.

Chart review: The investigators will also perform chart review to capture information that will inform whether the investigators achieved balance in treatment allocation groups on important factors related to study outcomes. Chart review will also provide covariate information which the investigators will use in outcome analysis. Through HIPAA authorization, the investigators will extract information related to age, gender, insurance status, prior AC use, CHA2DS2VASc stroke risk score, comorbidities associated with bleeding, and adherence to preventive health screening.

Data Security: Analyses will be performed using only limited datasets, and only aggregate data will be reported. All data will be used for research purposes only; published data will not contain any individual identifiers and will be reported in the aggregate.

The proposed study involves no more than minimal risk to participants.

The potential benefits to subjects from study participation include increased knowledge of atrial fibrillation and AC and improved rates of adherence to AC guidelines. This may in turn prevent strokes or limit bleeding that would otherwise have occurred without the benefit of this intervention.

Вмешательства

• Поведенческое Storytelling Intervention
  Participants assigned to the intervention group will watch videos presenting stories of African American patients about their experiences with using anticoagulation or blood thinners throughout a 90-day period.

Первичные конечные точки

• Fidelity via viewing time [Срок оценки: 90 days from randomization]
• Fidelity via transportation [Срок оценки: 90 days from randomization]
• Feasibility in terms of recruitment rates [Срок оценки: 90 days from randomization]
• Feasibility in terms of retention rates [Срок оценки: 90 days from randomization]
• Acceptability of participating in the study [Срок оценки: 90 days from randomization]
• Video testing on anticoagulation initiation behavior [Срок оценки: 6 months from randomization]
• Video testing on anticoagulation persistence behavior [Срок оценки: 6 months from randomization]

Критерии участия

Критерии включения

• African-American patients aged 18 or older with elevated stroke risk (CHA2DS2-VASc ≥2 for men and ≥3 for women) who are not currently on anticoagulation (AC) but for whom a cardiology provider or primary care provider at the two study sites recommended AC recently

Критерии исключения

• Non-African American and other non-Black patients under the age of 18 patients without an ICD-10 diagnostic code consistent with AF or atrial fibrillation or atrial flutter
• Patient without a visit with a primary care provider, cardiovascular medicine specialist, or ambulatory care provider in the previous one year
• Patient who is pregnant or a prisoner.
• Patients with left atrial appendage surgery or device, hospice status, ongoing bleeding, and intracranial bleeding in intralobar territory

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 4 центра

• Luis Ortega Paz — Jacksonville
• Decentralized — Worcester
• UMass Chan Medical School — Worcester
• University of Michigan Medical School — Ann Arbor

Идентификаторы

NCT: NCT05997914 · STUDY00001248 · R21MD017646

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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