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
Autor: | Xuan Pham, Ellen L. Poleshuck, Caron Zlotnick, Jennifer L. Blume, Rebecca Weinberg, Amanda King, Tiffany A. Moore Simas, Alla Sikorskii, Ted R. Miller, Jennifer E. Johnson, Shannon Wiltsey-Stirman |
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Přispěvatelé: | Division of Paediatric Surgery, Faculty of Health Sciences |
Jazyk: | angličtina |
Rok vydání: | 2018 |
Předmět: |
Postpartum depression
Cost-Benefit Analysis Psychological intervention Ambulatory Care Facilities Coaching law.invention Study Protocol 0302 clinical medicine Japan Randomized controlled trial Pregnancy law Outpatient clinic Medicine 030212 general & internal medicine Child education.field_of_study lcsh:R5-920 Health Policy Sustainment Health services research General Medicine 3. Good health Outcome and Process Assessment Health Care Female Prenatal care lcsh:Medicine (General) Public assistance medicine.medical_specialty Population Health Informatics Depression Postpartum 03 medical and health sciences Humans education Poverty business.industry Prevention Infant Newborn Public Health Environmental and Occupational Health medicine.disease 030227 psychiatry Family medicine Implementation Cost-effectiveness Pregnant Women business Program Evaluation |
Zdroj: | Implementation Science Implementation Science, Vol 13, Iss 1, Pp 1-12 (2018) Implementation Science : IS |
ISSN: | 0326-7563 |
Popis: | 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. |
Databáze: | OpenAIRE |
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