Abstract
PURPOSE: EvidenceNOW Southwest is a cluster-randomized trial evaluating the differential impact on cardiovascular disease (CVD) care of engaging patients and communities in practice transformation in addition to standard practice facilitation support. The trial included development of locally tailored CVD patient engagement materials through Boot Camp Translation (BCT), a community engagement process that occurred before practice recruitment but after cluster randomization. METHODS: We introduce a cluster randomization method performed before recruitment of small to medium-size primary care practices in Colorado and New Mexico, which allowed for balanced study arms while minimizing contamination. Engagement materials for the enhanced study arm were developed by means of BCT, which included community members, practice members, and public health professionals from (1) metropolitan Denver, (2) rural northeast Colorado, (3) Albuquerque, and (4) rural southeast New Mexico. Outcome measures were messages and materials from BCTs and population characteristics of study arms after using geographic-based covariate constrained randomization. RESULTS: The 4 BCTs' messages and materials developed by the BCT groups uniquely reflected each community and ranged from family or spiritual values to early prevention or adding relevance to CVD risk. The geographic-based covariate of a cluster randomization method constrained randomization-assigned regions to study arms, allowing BCTs to precede practice recruitment, reduce contamination, and balance populations. CONCLUSIONS: Cluster-randomized trials with community-based interventions present study design and implementation challenges. The BCTs elicited unique contextual messages and materials, suggesting that interventions designed to help primary care practices decrease CVD risk may not be one size fits all.