Clinical trial NCT05997914: Storytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation
Official title: Storytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation Randomized Trial (STORY-AF Trial)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Atrial Fibrillation
Atrial Flutter
Adherence, Medication
Anticoagulants and Bleeding Disorders
Stroke
Bleeding
Narration
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: National Institute on Minority Health and Health Disparities (NIMHD)
name: University of Florida
First posted: 2023-08-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fidelity via viewing time
timeFrame: 90 days from randomization
measure: Fidelity via transportation
timeFrame: 90 days from randomization
measure: Feasibility in terms of recruitment rates
timeFrame: 90 days from randomization
measure: Feasibility in terms of retention rates
timeFrame: 90 days from randomization
measure: Acceptability of participating in the study
timeFrame: 90 days from randomization
measure: Video testing on anticoagulation initiation behavior
timeFrame: 6 months from randomization
measure: Video testing on anticoagulation persistence behavior
timeFrame: 6 months from randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Luis Ortega Paz
state: Florida
city: Worcester
country: United States
facility: Decentralized
state: Massachusetts
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical School
state: Michigan
Study officials:
affiliation: UMass Chan Medical School
name: Alok Kapoor, MD
role: PRINCIPAL_INVESTIGATOR
References: