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.
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.
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DOI：
10.1186/s13012-018-0807-9
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发表时间：
2018-08-22
期刊：
影响因子：
--
通讯作者：
Zlotnick C
中科院分区：
文献类型：
--
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
需要对干预措施的可持续性进行更多的研究，特别是投资回报率研究，以确定维持所需努力的成本效益权衡，以及维持有效方案时的收益。ROSE维持（ROSES）研究采用序贯多重分配随机（SMART）设计，在90家为接受公共援助的孕妇提供产前护理的门诊诊所中，评估逐步维持ROSE产后抑郁预防计划的有效性和成本效益。产后抑郁症（PPD）是常见的，并可能产生持久的后果。提供产前护理的门诊诊所是提供PPD预防的合适场所，因为大多数妇女在怀孕期间访问。ROSE（Reach Out，Stay Strong，Essentials for Mothers of Neighbors）计划是一项预防产后抑郁症的团体教育干预措施，在怀孕期间实施。在为低收入孕妇提供服务的社区产前环境中，ROSE被发现可以减少PPD病例。所有90个产前诊所将照常接受强化实施（EIAU;初始培训+维持工具）。在第一次确定诊所处于无法维持的风险时（即，在3、6、9、12和15个月时），该诊所将被随机化以接受（1）没有额外的实施支持（即，仅EIAU），或（2）低强度辅导和反馈（LICF）。如果接受LICF的诊所在后续评估时仍存在风险，则将其随机分配至（1）仅EIAU + LICF，或（2）高强度指导和反馈（HICF）。将在18、24和30个月时进行额外的随访访谈，但18个月后将不进行实施干预。结果包括（1）每个时间点核心计划要素的维持百分比，（2）健康影响（每个诊所随时间推移的PPD率）和覆盖范围，以及（3）每个维持步骤的ROI（成本和成本效益）。假设的机制包括维持提供核心要素的能力和参与/自主权。这项研究是第一个随机试验评估的投资回报率的一个步骤的方法来维持，一个关键的未回答的问题，在实施科学。它还将促进对高危人群的实施机制和临床护理的了解。Clinicaltrials.gov，NCT 03267563。2018年6月14日注册。
More research on sustainment of interventions is needed, especially return on investment (ROI) studies to determine cost-benefit trade-offs for effort required to sustain and how much is gained when effective programs are sustained. The ROSE sustainment (ROSES) study uses a sequential multiple assignment randomized (SMART) design to evaluate the effectiveness and cost-effectiveness of a stepwise approach to sustainment of the ROSE postpartum depression prevention program in 90 outpatient clinics providing prenatal care to pregnant women on public assistance. Postpartum depression (PPD) is common and can have lasting consequences. Outpatient clinics offering prenatal care are an opportune place to provide PPD prevention because most women visit while pregnant. The ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) program is a group educational intervention to prevent PPD, delivered during pregnancy. ROSE has been found to reduce cases of PPD in community prenatal settings serving low-income pregnant women. All 90 prenatal 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, and 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 at risk at subsequent assessments, they will be randomized to either (1) EIAU + LICF only, or (2) high-intensity coaching and feedback (HICF). Additional follow-up interviews will occur at 18, 24, and 30 months, but no implementation intervention will occur after 18 months. Outcomes include (1) percent sustainment of core program elements at each time point, (2) health impact (PPD rates over time at each clinic) and reach, and (3) ROI (costs and cost-effectiveness) of each sustainment step. Hypothesized mechanisms include sustainment of capacity to deliver core elements and engagement/ownership. This study is 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. Clinicaltrials.gov, NCT03267563. Registered June 14, 2018.
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影响因子：
4.5
作者：
Crockett, Kathy;Zlotnick, Caron;Washington, Rosie
通讯作者：
Washington, Rosie
影响因子：
5.3
作者：
Chaudron, LH;Kitzman, HJ;Newman, MC
通讯作者：
Newman, MC
影响因子：
7.2
作者：
Cooper, Lisa A.;Ford, Daniel E.;Wang, Nae-Yuh
通讯作者：
Wang, Nae-Yuh
DOI：
10.1111/j.2517-6161.1995.tb02031.x
发表时间：
1995-01-01
影响因子：
5.8
作者：
BENJAMINI, Y;HOCHBERG, Y
通讯作者：
HOCHBERG, Y
影响因子：
2.3
作者：
Davila, Marivel;McFall, Stephanie L.;Cheng, Diana
通讯作者：
Cheng, Diana