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

实施以维持：确定最低限度的必要干预措施，以维持为低收入妇女提供产前服务的诊所的产后抑郁症预防计划（ROSE）

• 批准号: 10335232
• 负责人: JENNIFER E JOHNSON
• 金额: $ 67.82万
• 依托单位: MICHIGAN STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-01-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10335232
• 关键词: Accounting; Address; Adult; Ambulatory Care Facilities; Attention; Birth; Characteristics; Child; Childbirth; Clinic; Clinical; Communities; Consensus; Cost Analysis; Costs and Benefits; Development; Effectiveness; Elements; Enrollment; Evidence based intervention; Failure; Feedback; Follow-Up Studies; Future; Goals; Guidelines; Health; Healthcare; Individual; Infant; Intervention; Interview; Investments; Japan; Knowledge; Length; Longitudinal Studies; Low income; Mediator of activation protein; Medical; Monitor; Mothers; Newborn Infant; Outcome; Outpatients; Ownership; Patients; Perinatal; Philadelphia; Policies; Populations at Risk; Positioning Attribute; Postpartum Depression; Pregnancy; Pregnant Women; Prenatal care; Prevalence; Prevention program; Preventive; Primary Health Care; Process; Program Sustainability; Public Assistance; Quality of Care; Randomized; Replicating Effective Programs; Reporting; Research; Risk; Sequential Multiple Assignment Randomized Trial; Services; Surveys; Testing; Time; Training; Underserved Population; Visit; Woman; base; behavioral health; behavioral health intervention; clinical care; compare effectiveness; cost; cost effectiveness; economic outcome; ethnic diversity; functional status; group intervention; implementation intervention; implementation process; implementation science; improved; innovation; payment; pregnant; prenatal; prevent; prevention service; preventive intervention; programs; racial diversity; randomized effectiveness trial; randomized trial; suicidal risk; tool; uptake

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.

最近的一份专家共识报告得出的结论是：“对什么知之甚少 条件健康创新得到了维持，一旦将其付诸实践，就可以保持其收益。” 1 报告对进行投资回报率（ROI）研究确定了多少 持续有效的计划，并为维持所需的努力而定位。 产后抑郁症（PPD）很常见，可能对母子产生持久的后果。 提供产前护理的门诊诊所是提供PPD预防服务的机会 大多数妇女在怀孕时访问。玫瑰是预防PPD的小组干预，在怀孕期间交付 门诊产前设置。已经发现玫瑰可以显着减少多个随机的PPD病例 社区产前环境中的试验大致和种族多样化的低收入孕妇。 玫瑰训练和最近的政策变更请求，支持付款的全面围产期 服务不足的人群的服务表明，长期嵌入产前诊所中嵌入玫瑰的背景。 鉴于需要关于维持努力的投资回报率研究，并且罗斯有充分的位置用于可持续 研究研究，我们提出了一个随机的多次分配（智能）试验的有效性试验 以及在90个门诊诊所中维持玫瑰的逐步维持玫瑰的成本效益 在纽约州密歇根州，宾夕法尼亚州，宾夕法尼亚州，马萨诸塞州和佛罗里达州密歇根州的公共援助方面向孕妇提供产前护理。在第一年，所有诊所都将 像往常一样接受增强的实施（EIAU；初始培训 +维持工具）。第一次 该诊所被确定有未能维持的风险（即3、6、9、12、15个月），该诊所将是 随机接收：（1）无额外的实施支持（即仅EIAU）或（2）低强度 教练和反馈（LICF）。如果仍发现接受LICF的诊所在随后的评估中处于危险之中， 它们将仅随机分配给（1）EIAU + LICF，或（2）高强度教练和反馈（HICF）。 额外的研究后续访谈将在18、24和30个月进行，但没有实施干预 将在18个月后发生。结果包括：1。在每个时间点维持核心计划要素 提供了总玫瑰服务时间，并至少提供了适度的保真度。 2。健康 影响（每个诊所的PPD率均随着时间的推移）并触及到。 3。投资回报率（成本，成本率和成本效益） 每个维持步骤。假设的机制包括维持临床和组织能力 提供核心要素以及参与/所有权。该研究还将检查预测因素，裁缝 变量和实施过程，以确定哪种诊所需要哪种级别的维持水平 支持和何时。据我们所知，这项研究将是评估A的ROI的第一个随机试验 阶梯式维持方法，这是实施科学中关键的未解决的问题。它也会 提前了解实施机制和高危人群的临床护理。

项目成果

Protocol for the ROSE sustainment (ROSES) study, a sequential multiple assignment randomized trial to determine the minimum necessary intervention to maintain a postpartum depression prevention program in prenatal clinics serving low-income women.

• DOI: 10.1186/s13012-018-0807-9
• 发表时间: 2018-08-22
• 期刊: Implementation science : IS
• 作者: Johnson JE;Wiltsey-Stirman S;Sikorskii A;Miller T;King A;Blume JL;Pham X;Moore Simas TA;Poleshuck E;Weinberg R;Zlotnick C
• 通讯作者: Zlotnick C

Study protocol for the ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression prevention.

ROSE 扩大研究的研究方案：告知有关 ROSE 作为通用产后抑郁症预防的决定。

• DOI: 10.1016/j.cct.2023.107297
• 发表时间: 2023
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 作者: Johnson,JenniferE;Loree,AmyM;Sikorskii,Alla;Miller,TedR;Carravallah,Laura;Taylor,Brandon;Zlotnick,Caron
• 通讯作者: Zlotnick,Caron