Abstract W MP59: Spanish Language Consent Process Increases Prehospital Clinical Trial Enrollment in the Hispanic Community

Abstract

Background: At over 45.5 million and growing, Hispanics are the United States’ fastest emerging ethnic group. Hispanics have a different prevalence of risk factors for stroke when compared with non-Hispanic whites, including increased frequency of hypertension, diabetes and obesity. Adequate ethnic representation in clinical trials is important to assure generalizability of results. Methods to enhance the Hispanic participants include Spanish language consent processes. We describe Hispanic participants in a prehospital clinical trial using Spanish as well as English consent forms. Methods: The NIH Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Phase 3 Trial is a randomized study of prehospital initiated neuroprotection versus placebo in patients evaluated by paramedics less than two hours from symptom onset. After paramedics screened potential subjects, they dialed English or Spanish language enrollment lines, using voice-over-internet simulring numbers to directly connect to the cellphones of 4 Spanish-speaking or 4 English- speaking physician-investigators. Spanish speaking patients were able to learn about the study and be consented into the trial in their primary language. Results: There were 399 subjects enrolled in FAST-MAG who identified as Hispanic, 23% of the total cohort of 1700. Approximately half (48%) were enrolled using the Spanish- language consent process. Hispanic participants in FAST-MAG differed from non-Hispanic participants in several baseline characteristics, including being younger (65 vs. 71, p<0.001), more likely to have intracranial hemorrhage stroke subtype (33% vs. 20%, p<0.001), more often diabetic (32% vs. 19%, P<0.001), more severe baseline deficits (NIHSS 13 vs. 11, p=0.001) and higher systolic blood pressure (163 vs. 159, p=0.008). The two groups did not vary in gender, history of hypertension, time to paramedic evaluation, or rates of thrombolysis in cerebral ischemia. Conclusion: Better representation of Hispanics in clinical research is aided by availability of Spanish language consent processes. Dual language phone lines for consent elicitation are an effective strategy to increase enrollment of Hispanic participants in prehospital clinical research.