Examining Barriers and Practices to Recruitment and Retention in Stroke Clinical Trials. Issue 8 (August 2015)

• Record Type: Journal Article
• Authors: Boden-Albala, Bernadette; Carman, Heather; Southwick, Lauren; Parikh, Nina S.; Roberts, Eric; Waddy, Salina; Edwards, Dorothy
• Is Part Of: Stroke. Volume 46:Issue 8(2015)
• Publication Date: 2015-08
• Subjects: clinical trial -- ethnic groups -- health policy -- National Institutes of Health (US) -- stroke; Cerebrovascular disease -- Periodicals; Cerebral circulation -- Periodicals; 616.81
• DOI: 10.1161/STROKEAHA.114.008564
• Languages: English
• ISSNs: 0039-2499

Abstract

Abstract : 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. Abstract : Supplemental Digital Content is available in the text.