Cabassa Leopoldo J, Stefancic Ana, O'Hara Kathleen, El-Bassel Nabila, Lewis-Fernández Roberto, Luchsinger José A, Gates Lauren, Younge Richard, Wall Melanie, Weinstein Lara, Palinkas Lawrence A
Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA.
New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10032, USA.
Trials. 2015 Sep 2;16:388. doi: 10.1186/s13063-015-0902-z.
The risk for obesity is twice as high in people with serious mental illness (SMI) compared to the general population. Racial and ethnic minority status contribute additional health risks. The aim of this study is to describe the protocol of a Hybrid Trial Type 1 design that will test the effectiveness and examine the implementation of a peer-led healthy lifestyle intervention in supportive housing agencies serving diverse clients with serious mental illness who are overweight or obese.
The Hybrid Trial Type 1 design will combine a randomized effectiveness trial with a mixed-methods implementation study. The effectiveness trial will test the health impacts of a peer-led healthy lifestyle intervention versus usual care in supportive housing agencies. The healthy lifestyle intervention is derived from the Group Lifestyle Balanced Program, lasts 12 months, and will be delivered by trained peer specialists. Repeated assessments will be conducted at baseline and at 6, 12, and 18 months post randomization. A mixed-methods (e.g., structured interviews, focus groups, surveys) implementation study will be conducted to examine multi-level implementation factors and processes that can inform the use of the healthy lifestyle intervention in routine practice, using data from agency directors, program managers, staff, and peer specialists before, during, and after the implementation of the effectiveness trial.
This paper describes the use of a hybrid research design that blends effectiveness trial methodologies and implementation science rarely used when studying the physical health of people with SMI and can serve as a model for integrating implementation science and health disparities research. Rigorously testing effectiveness and exploring the implementation process are both necessary steps to establish the evidence for large-scale delivery of peer-led healthy lifestyle intervention to improve the physical health of racial/ethnic minorities with SMI.
www.clinicaltrials.gov; NCT02175641, registered 24 June 2014.
与普通人群相比，患有严重精神疾病（SMI）的人肥胖风险高出两倍。种族和少数民族身份会带来额外的健康风险。本研究的目的是描述一种1型混合试验设计的方案，该方案将测试一种由同伴主导的健康生活方式干预措施在为患有严重精神疾病且超重或肥胖的不同客户提供服务的支持性住房机构中的有效性，并考察其实施情况。
1型混合试验设计将把随机有效性试验与混合方法实施研究相结合。有效性试验将在支持性住房机构中测试由同伴主导的健康生活方式干预措施与常规护理相比对健康的影响。健康生活方式干预措施源自“团体生活平衡计划”，为期12个月，将由经过培训的同伴专家提供。在基线以及随机分组后的6个月、12个月和18个月进行重复评估。将开展一项混合方法（如结构化访谈、焦点小组、调查）实施研究，以考察多层次的实施因素和过程，这些因素和过程可为在常规实践中使用健康生活方式干预措施提供参考，使用的数据来自机构主管、项目经理、工作人员以及同伴专家在有效性试验实施前、实施期间和实施后的情况。
本文描述了一种混合研究设计的应用，该设计将有效性试验方法与实施科学相结合，而在研究患有严重精神疾病者的身体健康时很少使用这种方法，并且可作为整合实施科学与健康差异研究的一个范例。严格测试有效性并探索实施过程，都是为大规模提供由同伴主导的健康生活方式干预措施以改善患有严重精神疾病的种族/少数民族的身体健康建立证据的必要步骤。
