Effect of Stroke Education Pamphlets vs a 12-Minute Culturally Tailored Stroke Film on Stroke Preparedness Among Black and Hispanic Churchgoers: A Cluster Randomized Clinical Trial

Abstract

Importance: Black individuals and Hispanic individuals are less likely to recognize stroke and call 911 (stroke preparedness), contributing to racial/ethnic disparities in intravenous tissue plasminogen activator use.

Objective: To evaluate the effect of culturally tailored 12-minute stroke films on stroke preparedness vs the usual care practice of distributing stroke education pamphlets.

Design, setting, and participants: Cluster randomized clinical trial between July 26, 2013, and August 16, 2018, with randomization of 13 black and Hispanic churches located in urban neighborhoods to intervention or usual care. In total, 883 congregants were approached, 503 expressed interest, 375 completed eligibility screening, and 312 were randomized. Sixty-three individuals were ineligible (younger than 34 years and/or did not have at least 1 traditional stroke risk factor).

Interventions: Two 12-minute stroke films on stroke preparedness for black and Hispanic audiences.

Main outcomes and measures: The primary outcome was the Stroke Action Test (STAT), assessed at baseline, 6 months, and 12 months.

Results: In total, 261 of 312 individuals completed the study (83.7% retention rate). Most participants were female (79.1%). The mean (SD) age of participants was 58.57 (11.66) years; 51.1% (n = 159) were non-Hispanic black, 48.9% (n = 152) were Hispanic, and 31.7% (n = 99) had low levels of education. There were no significant end-point differences for the STAT at follow-up periods. The mean (SD) baseline STAT scores were 59.05% (29.12%) correct for intervention and 58.35% (28.83%) correct for usual care. At 12 months, the mean (SD) STAT scores were 64.38% (26.39%) correct for intervention and 61.58% (28.01%) correct for usual care. Adjusted by education, a post hoc subgroup analysis revealed a mean (SE) intervention effect of 1.03% (0.44%) (P = .02) increase per month in the low-education subgroup (about a 10% increase in 12 months). In the high-education subgroup, the mean (SE) intervention effect was -0.05% (0.30%) (P = .86). Regarding percentage correct, the low-education intervention subgroup improved from 52.4% (7 of 21) to 66.7% (14 of 21) compared with the other subgroups.

Conclusions and relevance: No difference was observed in stroke preparedness at 12 months in response to culturally tailored 12-minute stroke films or conventional stroke education pamphlets. Additional studies are required to confirm findings from a post hoc subgroup analysis that suggested a significant education effect.

Trial registration: ClinicalTrials.gov identifier: NCT01909271.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Williams reported receiving grants from the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH). Dr Teresi reported receiving grants from the NIH. Ms Gomez Chan reported receiving grants from the NINDS. Dr Ravenell reported receiving grants from the NIH. Dr Noble reported receiving grant U54NS081765 from the NINDS. No other disclosures were reported.

Figures

Figure 1.. CONSORT Flow Diagram

CONSORT indicates Consolidated Standards of Reporting Trials.

Figure 2.. Model-Based STAT Number of Questions Answered Correctly by Treatment Group and Education Subgroup (n = 309)

Model-based means from the mean change model analyses are based on repeated-measures mixed-model analyses, adjusting for clustering within churches. An unstructured covariance structure was assumed. Comparison of the usual care and intervention slopes over time in the low-education subgroup (0-11 years) yielded a significant increase of 2.28 (P = .03). There was no significant change between slopes in the high-education subgroup (−0.02; P = .98). STAT indicates Stroke Action Test.