Abstract T P119: Effective Pre-Planned Center Selection to Optimize Sample Heterogeneity in the Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Multi-site Trial
For phase III RCTs, sample heterogeneity is useful for both generalizability of findings and providing insight into treatment effects for specific subgroups. Prior studies in stroke rehabilitation have rarely explored differences in intervention effects between racial and ethnic subgroups across participating sites. We examined participant characteristics across centers, with the hypothesis that strategic use of a multi-center structure across 3 distinct urban geographical areas (Atlanta, GA, Los Angeles, CA and Washington, DC) would generate a sample diverse enough to explore differences in treatment effects by racial and ethnic subgroups
Methods: The ICARE Stroke Initiative is a randomized multi-center clinical trial designed to compare the effectiveness of the Accelerated Skill Acquisition Program (ASAP) to an equivalent dose of usual and customary outpatient occupational therapy (DEUCC) and a monitoring only usual therapy group (UCC). Demographics, stroke characteristics and cognitive outcomes collected at baseline for randomized participants (N = 361) were compared across the 3 centers using ANOVA or χ2 tests for continuous and categorical outcomes, respectively.
Results: We found significant differences in race and ethnicity (p<0.001); the highest proportion of African-Americans came from the Atlanta and DC centers, and the highest proportion of Hispanic/Latinos came from the Los Angeles center. Additional unanticipated differences between centers in baseline characteristics include: age, referral source, stroke location, stroke severity as measured by the NIH Stroke Scale, Short Blessed Memory Test, DKEF’s verbal fluency sub-score of category switching, and pre-randomization hours of outpatient occupational therapy (p<0.05).
Conclusions: ICARE’s strategic center selection resulted in a diverse and robust dataset, allowing for post hoc exploration of treatment effect differences by subgroup and for the intention-to-treat analysis, determination of generalizability of treatment effects across a racially and ethnically diverse population.
Author Disclosures: M.A. Nelsen: None. C. Park: None. C.J. Lane: None. S.L. Wolf: None. A.W. Dromerick: None. C.J. Winstein: None.
- © 2014 by American Heart Association, Inc.