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

University of Massachusetts, Worcester

Status: Invitation-only

Conditions: Atrial Flutter; Atrial Fibrillation; Stroke; Adherence, Medication; Narration; Anticoagulants and Bleeding Disorders; Bleeding

Treatments: Behavioral: Storytelling Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05997914

R21MD017646 (U.S. NIH Grant/Contract)

STUDY00001248

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Intervention - Patient Videos

Experimental group

Description:

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.

Treatment:

Behavioral: Storytelling Intervention

Control - Informational Videos (not patients)

No Intervention group

Description:

Informational videos about anticoagulation and blood thinners presented by experts or actors.