Department of Family Medicine, University of Colorado School of Medicine, Aurora, Colorado
Department of Family Medicine, University of Colorado School of Medicine, Aurora, Colorado.
Ann Fam Med. 2018 Apr;16(Suppl 1):S58-S64. doi: 10.1370/afm.2173.
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.
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.
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.
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.
EvidenceNOW 西南是一项集群随机试验，评估在为患者和社区提供实践转化的同时为标准实践提供促进支持，对心血管疾病（CVD）护理的影响差异。该试验包括通过 Boot Camp Translation（BCT）开发针对当地情况的 CVD 患者参与材料，这是一种在实践招募之前但在集群随机分组之后进行的社区参与过程。
我们引入了一种在科罗拉多州和新墨西哥州的小型和中型初级保健实践招募之前进行的集群随机化方法，该方法允许平衡研究组，同时最大限度地减少污染。强化研究组的参与材料是通过 BCT 开发的，该方法包括来自（1）丹佛都会区、（2）科罗拉多州东北部农村、（3）阿尔伯克基和（4）新墨西哥州东南部农村的社区成员、实践成员和公共卫生专业人员。结局指标是 BCT 产生的信息和材料，以及使用基于地理的协变量约束随机化后研究组的人口特征。
4 个 BCT 组开发的 BCT 信息和材料独特地反映了每个社区，范围从家庭或精神价值观到早期预防或增加 CVD 风险的相关性。基于地理的集群随机化方法的协变量限制了随机化分配区域到研究组，从而允许 BCT 在实践招募之前进行，减少污染并平衡人群。
具有基于社区的干预措施的集群随机试验存在研究设计和实施挑战。BCT 引出了独特的背景信息和材料，表明旨在帮助初级保健实践降低 CVD 风险的干预措施可能并非一刀切。
