Efficacy of a Discharge Educational Strategy vs Standard Discharge Care on Reduction of Vascular Risk in Patients With Stroke and Transient Ischemic Attack: The DESERVE Randomized Clinical Trial.

Importance: Despite secondary prevention strategies with proven efficacy, recurrent stroke rates remain high, particularly in racial/ethnic minority populations who are disproportionately affected by stroke. Objective: To determine the efficacy of a culturally tailored skills-based educational intervention with telephone follow-up compared with standard discharge care on systolic blood pressure reduction in a multiethnic cohort of patients with mild/moderate stroke/transient ischemic attack. Design, Setting, and Participants: Randomized clinical trial with 1-year follow-up. Participants were white, black, and Hispanic patients with mild/moderate stroke/transient ischemic attack prospectively enrolled from 4 New York City, New York, medical centers during hospitalization or emergency department visit between August 2012 and May 2016. Through screening of stroke admissions and emergency department notifications, 1083 eligible patients were identified, of whom 256 declined to participate and 275 were excluded for other reasons. Analyses were intention to treat. Interventions: The Discharge Educational Strategies for Reduction of Vascular Events (DESERVE) intervention is a skills-based, culturally tailored discharge program with follow-up calls delivered by a community health coordinator. This intervention was developed using a community engagement approach. Main Outcomes and Measures: The primary outcome was systolic blood pressure reduction at 12 months postdischarge. Results: A total of 552 participants were randomized to receive intervention or usual care (281 women [51%]; mean [SD] age, 64.61 [2.9] years; 180 Hispanic [33%], 151 non-Hispanic white [27%], and 183 non-Hispanic black [33%]). At 1-year follow-up, no significant difference in systolic blood pressure reduction was observed between intervention and usual care groups (ß = 2.5 mm Hg; 95% CI, -1.9 to 6.9). Although not powered for subgroup analysis, we found that among Hispanic individuals, the intervention arm had a clinically and statically significant 9.9 mm Hg-greater mean systolic blood pressure reduction compared with usual care (95% CI, 1.8-18.0). There were no significant differences between arms among non-Hispanic white (ß = 3.3; 95% CI, -4.1 to 10.7) and non-Hispanic black participants (ß = -1.6; 95% CI, -10.1 to 6.8). Conclusions and Relevance: Few behavioral intervention studies in individuals who have had stroke have reported clinically meaningful reductions in blood pressure at 12 months, and fewer have focused on a skills-based approach. Results of secondary analyses suggest that culturally tailored, skills-based strategies may be an important alternative to knowledge-focused approaches in achieving sustained vascular risk reduction and addressing racial/ethnic stroke disparities; however, these findings should be tested in future studies. Trial Registration: ClinicalTrials.gov identifier: NCT01836354.

Discharge educational strategies for reduction of vascular events (DESERVE): design and methods.

RATIONALE: Stroke and vascular risk factors disproportionately affect minority populations, with Blacks and Hispanics experiencing a 2·5- and 2·0-fold greater risk compared with whites, respectively. Patients with transient ischemic attacks and mild, nondisabling strokes tend to have short hospital stays, rapid discharges, and inaccurate perceptions of vascular risk. AIM: The primary aim of the Discharge Educational Strategies for Reduction of Vascular Events (DESERVE) trial is to evaluate the efficacy of a novel community health worker-based multilevel discharge intervention vs. standard discharge care on vascular risk reduction among racially/ethnically diverse transient ischemic attack/mild stroke patients at one-year postdischarge. We hypothesize that those randomized to the discharge intervention will have reduced modifiable vascular risk factors as determined by systolic blood pressure compared with those receiving usual care. SAMPLE SIZE ESTIMATES: Given 300 subjects per group and alpha of 0·05, the power to detect a 6 mmHg reduction in systolic blood pressure is 89%. DESIGN: DESERVE trial is a prospective, randomized, multicenter clinical trial of a novel discharge behavioral intervention. Patients with transient ischemic attack/mild stroke are randomized during hospitalization or emergency room visit to intervention or usual care. Intervention begins prior to discharge and continues postdischarge. STUDY OUTCOMES: The primary outcome is difference in systolic blood pressure reduction between groups at 12 months. Secondary outcomes include between-group differences in change in glycated hemoglobin, smoking rates, medication adherence, and recurrent stroke/transient ischemic attack at 12 months. DISCUSSION: DESERVE will evaluate whether a novel discharge education strategy leads to improved risk factor control in a racially diverse population.

Examining Barriers and Practices to Recruitment and Retention in Stroke Clinical Trials.

BACKGROUND AND PURPOSE: The National Institutes of Health policy calls for the inclusion of under-represented groups, such as women and minorities, in clinical research. Poor minority recruitment and retention in stroke clinical trials remain a significant challenge limiting safety and efficacy in a general population. Previous research examines participant barriers to clinical trial involvement, but little is known about the investigator perspective. This study addresses this gap and examines researcher-reported barriers and best practices of minority involvement in stroke clinical trials. METHODS: Quantitative and qualitative methods, including surveys, focus groups, and key informant interviews were used. RESULTS: In a survey of 93 prominent stroke researchers, 43 (51.2%; 70% response rate) respondents reported proactively setting recruitment goals for minority inclusion, 29 respondents (36.3%) reported requiring cultural competency staff training, and 44 respondents (51.2%) reported using community consultation about trial design. Focus groups and key informant interviews highlighted structural and institutional challenges to recruitment of minorities, including mistrust of the research/medical enterprise, poor communication, and lack of understanding of clinical trials. Researcher-identified best practices included using standardized project management procedures and protocols (eg, realistic budgeting to support challenges in recruitment, such as travel/parking reimbursement for participants), research staff cultural competency and communication training, and developing and fostering community partnerships that guide the research process. CONCLUSIONS: This study's formative evaluation contributes a new dimension to the literature as it highlights researcher-reported barriers and best practices for enhancing participation of minority populations into stroke clinical trials.

Dietary interventions to lower the risk of stroke.

Stroke is a major cause of death and permanent disability in the USA; primary prevention and risk reduction are a critical health concern. A wealth of research investigated stroke risk factors, including primary hypertension, diabetes, and atrial fibrillation. Research has expanded to examine lifestyle factors, such as diet/dietary patterns, physical activity, cigarette smoking, and obesity distribution, as critical modifiable risk factors. Emerging evidence suggests diet/dietary patterns may lead to heightened risk of stroke. Despite a growing literature, research has yet to implement dietary interventions to explore this relationship within a US sample. This review discusses available clinical research findings reporting on the relationship among diet/dietary patterns, cardiovascular disease, and risk of stroke. We will assess challenges, limitations, and controversies, and address future research directions.

Perception of recurrent stroke risk among black, white and Hispanic ischemic stroke and transient ischemic attack survivors: the SWIFT study.

OBJECTIVES: Risk modification through behavior change is critical for primary and secondary stroke prevention. Theories of health behavior identify perceived risk as an important component to facilitate behavior change; however, little is known about perceived risk of vascular events among stroke survivors. METHODS: The SWIFT (Stroke Warning Information and Faster Treatment) study includes a prospective population-based ethnically diverse cohort of ischemic stroke and transient ischemic attack survivors. We investigate the baseline relationship between demographics, health beliefs, and knowledge on risk perception. Regression models examined predictors of inaccurate perception. RESULTS: Only 20% accurately estimated risk, 10% of the participants underestimated risk, and 70% of the 817 study participants significantly overestimated their risk for a recurrent stroke. The mean perceived likelihood of recurrent ischemic stroke in the next 10 years was 51 ± 7%. We found no significant differences by race-ethnicity with regard to accurate estimation of risk. Inaccurate estimation of risk was associated with attitudes and beliefs [worry (p < 0.04), fatalism (p < 0.07)] and memory problems (p < 0.01), but not history or knowledge of vascular risk factors. CONCLUSION: This paper provides a unique perspective on how factors such as belief systems influence risk perception in a diverse population at high stroke risk. There is a need for future research on how risk perception can inform primary and secondary stroke prevention.