Storytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation Randomized Trial (STORY-AF Trial)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Fidelity via viewing time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention - Patient Videos
Videos of African Americans currently taking anticoagulation talking about their experiences with using anticoagulation or blood thinners and successfully navigating setbacks occurring with use including bleeding, falls, strokes, and affording the medications.
干预措施: Storytelling Intervention (Behavioral)
Control - Informational Videos (not patients)
Informational videos about anticoagulation and blood thinners presented by experts or actors.
结局指标
主要结局
Fidelity via viewing time
时间窗: 90 days from randomization
Time spent viewing videos
Feasibility in terms of recruitment rates
时间窗: 90 days from randomization
The investigators will calculate the proportion of patients recruited as well as the recruitment rate. The recruitment proportion will be the number of patients randomized over the total of patients approached. The recruitment rate will be the total time (in days) required to recruit the randomized sample.
Fidelity via transportation
时间窗: 90 days from randomization
In intervention patients, measure transportation (absorption into a story) using a transportation scale short form where the minimum and maximum values are 1 (Not at all) and 7 (Very much), respectively. Higher scores mean a better outcome (high transportation).
Acceptability of participating in the study
时间窗: 90 days from randomization
Participants will be asked to use an acceptability scale (which the investigators will develop later during the study) to rate their agreement with statements about the acceptability of using the video website, completing the transportation scale short survey (intervention participants only), and participating in the study in general.
Feasibility in terms of retention rates
时间窗: 90 days from randomization
The investigators will calculate the per-group retention proportion as the number of individuals from each group remaining in the study after its completion over the total randomized to that group.
Video testing on anticoagulation initiation behavior
时间窗: 6 months from randomization
The investigators will review charts (electronic medical records) of study participants for frequency of anticoagulation (AC) initiation (switch from being off AC to being on AC) in intervention vs. controls over the six months from randomization in patients who start AC.
Video testing on anticoagulation persistence behavior
时间窗: 6 months from randomization
The investigators will review charts (electronic medical records) of study participants for anticoagulation (AC) persistence (duration of AC use measured in days from baseline) in intervention vs. controls over the six months from randomization in patients who start AC.
次要结局
未报告次要终点
研究者
Alok Kapoor
Professor of Medicine
University of Massachusetts, Worcester