Implementing to sustain: Determining the minimum necessary intervention to maintain a postpartum depression prevention program (ROSE) in clinics providing prenatal services to low-income women

最近的一份专家共识报告得出结论说，人们对什么井或什么情况知之甚少 条件健康创新一旦付诸实施，就会持续下去，并保持其成果。 报告高度重视进行投资回报(ROI)研究，以确定收益 当有效的项目得以持续，并且需要对所需的努力进行成本效益权衡时。 产后抑郁症(PPD)很常见，可能会对母亲和孩子产生持久的影响。 提供产前护理的门诊是提供产后抑郁预防服务的好地方，因为 大多数女性在怀孕期间前来就诊。ROSE是一项集体干预措施，旨在预防PPD，在#年怀孕期间分娩 门诊产前检查。玫瑰已经被发现在多个随机分组中显著减少了PPD的病例 在社区产前环境中对不同种族和民族的低收入孕妇进行试验。 申请ROSE培训和最近的政策变化，支持支付全面围产期费用 为服务不足的人群提供的服务表明，长期将玫瑰植入产前诊所的时机已经成熟。 考虑到关于持续努力的ROI研究的需要，以及ROSE处于维持的有利地位- 研究中，我们提出了一种序贯多任务随机(SMART)试验的有效性 循序渐进的方法在90家门诊诊所维持玫瑰的成本效益 在MI、NY、RI、PA、MA和FL的公共援助下为孕妇提供产前护理。在第一年，所有诊所将 照常加强执行(环评股；初步培训+维持工具)。在第一时间 诊所被确定为有无法维持的风险(即，在3、6、9、12、15个月)，则该诊所将 随机接受：(1)无额外实施支持(即，仅EIAU)，或(2)低强度 指导和反馈(LICF)。如果接受LICF的诊所在随后的评估中仍有风险， 他们将被随机分为(1)EIAU+LICF组，或(2)高强度指导和反馈组(HICF)。 额外的研究跟踪访谈将在18、24和30个月进行，但没有实施干预 将在18个月后发生。成果包括：1.在每个时间点维持核心方案要素和 提供ROSE服务的总时间长度至少为中等保真度。2.健康 影响(每个诊所随着时间的推移PPD率)和覆盖范围。3.投资回报(成本、成本抵销和成本效益) 每一个维持步骤。假设的机制包括维持临床和组织能力 提供核心要素和参与度/所有权。这项研究还将检查预测因素，定制 变量和实施过程，以确定哪些类型的诊所需要哪种级别的支持 支持和何时支持。据我们所知，这项研究将是第一个评估投资回报率的随机试验 实施科学中尚未回答的关键问题--可持续发展的阶段性方法。它还将 深入了解高危人群的实施机制和临床护理。

A recent expert consensus report concluded that, “Little is known about how well or under what conditions health innovations are sustained and their gains maintained once they are put into practice.”1 This report placed high priority on conducting return on investment (ROI) studies to determine how much is gained when effective programs are sustained, and cost-benefit trade-offs for effort required to sustain. Postpartum depression (PPD) is common and can have lasting consequences for mother and child. Outpatient clinics offering prenatal care are an opportune place to deliver PPD prevention services because most women visit while pregnant. ROSE is a group intervention to prevent PPD, delivered during pregnancy in outpatient prenatal settings. ROSE has been found to significantly reduce cases of PPD in multiple randomized trials in community prenatal settings with racially and ethnically diverse low-income pregnant women. Requests for ROSE training and recent policy changes supporting payment for comprehensive perinatal services to underserved populations suggest a context ripe for embedding ROSE in prenatal clinics long-term. Given the need for ROI studies about sustainment efforts and that ROSE is well-positioned for sustain- ment research, we propose a Sequential Multiple Assignment Randomized (SMART) Trial of the effectiveness and cost-effectiveness of a stepwise approach to sustainment of ROSE in 90 outpatient clinics providing prenatal care to pregnant women on public assistance in MI, NY, RI, PA, MA, and FL. In Year 1, all clinics will receive enhanced implementation as usual (EIAU; initial training + tools for sustainment). At the first time at which a clinic is determined to be at risk for failure to sustain (i.e., at 3, 6, 9, 12, 15 months), that clinic will be randomized to receive either: (1) no additional implementation support (i.e., EIAU only), or (2) low-intensity coaching and feedback (LICF). If clinics receiving LICF are still found to be at risk at subsequent assessments, they will be randomized to either (1) EIAU + LICF only, or (2) high-intensity coaching and feedback (HICF). Additional study follow-up interviews will occur at 18, 24, and 30 months, but no implementa-tion intervention will occur after 18 months. Outcomes include: 1. Sustainment of core program elements at each time point and total length of time ROSE services were provided and were provided with at least moderate fidelity. 2. Health impact (PPD rates over time at each clinic) and reach. 3. ROI (costs, cost-offsets, and cost-effectiveness) of each sustainment step. Hypothesized mechanisms include sustainment of clinical and organizational capacity to deliver core elements, and engagement/ownership. The study will also examine predictors, tailoring variables, and implementation processes to determine which kinds of clinics need which level of sustainment support and when. To our knowledge, this study will be the first randomized trial evaluating the ROI of a stepped approach to sustainment, a critical unanswered question in implementation science. It will also advance knowledge of implementation mechanisms and clinical care for an at-risk population.