RESUMO
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.
RESUMO
BACKGROUND: Stroke is a leading cause of adult disability and mortality. Intravenous thrombolysis can minimize disability when patients present to the emergency department for treatment within the 3 - 4½ h of symptom onset. Blacks and Hispanics are more likely to die and suffer disability from stroke than whites, due in part to delayed hospital arrival and ineligibility for intravenous thrombolysis for acute stroke. Low stroke literacy (poor knowledge of stroke symptoms and when to call 911) among Blacks and Hispanics compared to whites may contribute to disparities in acute stroke treatment and outcomes. Improving stroke literacy may be a critical step along the pathway to reducing stroke disparities. The aim of the current study is to test a novel intervention to increase stroke literacy in minority populations in New York City. DESIGN AND METHODS: In a two-arm cluster randomized trial, we will evaluate the effectiveness of two culturally tailored stroke education films - one in English and one in Spanish - on changing behavioral intent to call 911 for suspected stroke, compared to usual care. These films will target knowledge of stroke symptoms, the range of severity of symptoms and the therapeutic benefit of calling 911, as well as address barriers to timely presentation to the hospital. Given the success of previous church-based programs targeting behavior change in minority populations, this trial will be conducted with 250 congregants across 14 churches (125 intervention; 125 control). Our proposed outcomes are (1) recognition of stroke symptoms and (2) behavioral intent to call 911 for suspected stroke, measured using the Stroke Action Test at the 6-month and 1-year follow-up. DISCUSSION: This is the first randomized trial of a church-placed narrative intervention to improve stroke outcomes in urban Black and Hispanic populations. A film intervention has the potential to make a significant public health impact, as film is a highly scalable and disseminable medium. Since there is at least one church in almost every neighborhood in the USA, churches have the ability and reach to play an important role in the dissemination and translation of stroke prevention programs in minority communities. TRIAL REGISTRATION: NCT01909271 ; July 22, 2013.