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
Department of Obstetrics and Gynecology
Community Health and Preventive Medicine | Female Urogenital Diseases and Pregnancy Complications | Maternal and Child Health | Mental Disorders | Obstetrics and Gynecology | Women's Health
BACKGROUND: 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.
METHODS: 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.
DISCUSSION: 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.
TRIAL REGISTRATION: Clinicaltrials.gov, NCT03267563 . Registered June 14, 2018.
Cost-effectiveness, Implementation, Postpartum depression, Prenatal care, Prevention, Public assistance, Sustainment
Rights and Permissions
© The Author(s). 2018 Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
DOI of Published Version
Implement Sci. 2018 Aug 22;13(1):115. doi: 10.1186/s13012-018-0807-9. Link to article on publisher's site
Implementation science : IS
Johnson, Jennifer E.; Wiltsey-Stirman, Shannon; Sikorskii, Alla; Miller, Ted; King, Amanda; Blume, Jennifer L.; Pham, Xuan; Moore Simas, Tiffany A.; Poleshuck, Ellen; Weinberg, Rebecca; and Zlotnick, Caron, "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" (2018). Open Access Articles. 3571.
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.
Community Health and Preventive Medicine Commons, Female Urogenital Diseases and Pregnancy Complications Commons, Maternal and Child Health Commons, Mental Disorders Commons, Obstetrics and Gynecology Commons, Women's Health Commons