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认为，“人们对如何或在什么情况下工作知之甚少， 卫生创新得以持续并在付诸实施后保持其成果的条件。1本 报告高度重视进行投资回报率（ROI）研究，以确定获得多少收益 当有效的计划得以持续时，以及为维持所需的努力而进行的成本效益权衡。 产后抑郁症（PPD）很常见，可能对母亲和孩子产生持久的影响。 提供产前护理的门诊诊所是提供PPD预防服务的合适场所，因为 大多数女性在怀孕期间都会去看医生。ROSE是一种预防PPD的团体干预措施， 门诊产前设置。在多个随机化研究中，发现ROSE可显著减少PPD病例 在社区产前环境中对不同种族和族裔的低收入孕妇进行试验。 要求ROSE培训和最近的政策变化，支持支付全面围产期保健费用 对服务不足人群的服务表明，将ROSE长期嵌入产前诊所的背景已经成熟。 鉴于需要对维持工作进行投资回报率研究，而且ROSE处于维持的有利地位， 研究，我们提出了一个序贯多分配随机（SMART）试验的有效性， 在90个门诊诊所采取逐步维持ROSE的方法， 在密歇根州、纽约州、罗德岛州、宾夕法尼亚州、马萨诸塞州和佛罗里达州，向接受公共援助的孕妇提供产前护理。 照常接受强化实施（EIAU;初始培训+维持工具）。第一次在 诊所被确定为处于不能维持的风险中（即，在3、6、9、12、15个月时），该诊所将 随机接受：（1）没有额外的实施支持（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然存在风险， 他们将被随机分配到（1）仅EIAU + LICF，或（2）高强度指导和反馈（HICF）。 将在18、24和30个月时进行额外的研究随访访谈，但不进行实施干预 将在18个月后发生。结果包括：1.在每个时间点维持核心计划要素， 提供ROSE服务的总时间长度，并且至少以中等保真度提供。2.健康 影响（每个诊所随时间推移的PPD率）和覆盖范围。3.投资回报率（成本、成本抵消和成本效益） 每个维持步骤。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/所有权。这项研究还将研究预测因素， 变量和实施流程，以确定哪种类型的诊所需要哪种水平的维持 支持和时间。据我们所知，这项研究将是第一个随机试验，评估投资回报率的一个 这是实施科学中一个尚未回答的关键问题。它还将 提高对高危人群实施机制和临床护理的认识。

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.