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
| dc.contributor.author | Johnson, Jennifer E | |
| dc.contributor.author | Wiltsey-Stirman, Shannon | |
| dc.contributor.author | Sikorskii, Alla | |
| dc.contributor.author | Miller, Ted | |
| dc.contributor.author | King, Amanda | |
| dc.contributor.author | Blume, Jennifer L | |
| dc.contributor.author | Pham, Xuan | |
| dc.contributor.author | Moore Simas, Tiffany A | |
| dc.contributor.author | Poleshuck, Ellen | |
| dc.contributor.author | Weinberg, Rebecca | |
| dc.contributor.author | Zlotnick, Caron | |
| dc.date.accessioned | 2018-09-10T10:07:19Z | |
| dc.date.available | 2018-09-10T10:07:19Z | |
| dc.date.issued | 2018-08-22 | |
| dc.date.updated | 2018-08-26T03:21:20Z | |
| dc.description.abstract | 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. | |
| dc.identifier.apacitation | Johnson, J. E., Wiltsey-Stirman, S., Sikorskii, A., Miller, T., King, A., Blume, J. L., ... Zlotnick, C. (2018). 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. <i>Implementation Science</i>, http://hdl.handle.net/11427/28455 | en_ZA |
| dc.identifier.chicagocitation | Johnson, Jennifer E, Shannon Wiltsey-Stirman, Alla Sikorskii, Ted Miller, Amanda King, Jennifer L Blume, Xuan Pham, et al "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." <i>Implementation Science</i> (2018) http://hdl.handle.net/11427/28455 | en_ZA |
| dc.identifier.citation | Johnson, J. E., Wiltsey-Stirman, S., Sikorskii, A., Miller, T., King, A., Blume, J. L., ... & Zlotnick, C. (2018). 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. Implementation Science, 13(1), 115. | |
| dc.identifier.ris | TY - Journal Article AU - Johnson, Jennifer E AU - Wiltsey-Stirman, Shannon AU - Sikorskii, Alla AU - Miller, Ted AU - King, Amanda AU - Blume, Jennifer L AU - Pham, Xuan AU - Moore Simas, Tiffany A AU - Poleshuck, Ellen AU - Weinberg, Rebecca AU - Zlotnick, Caron AB - 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. DA - 2018-08-22 DB - OpenUCT DP - University of Cape Town J1 - Implementation Science LK - https://open.uct.ac.za PB - University of Cape Town PY - 2018 T1 - 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 TI - 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 UR - http://hdl.handle.net/11427/28455 ER - | en_ZA |
| dc.identifier.uri | https://doi.org/10.1186/s13012-018-0807-9 | |
| dc.identifier.uri | http://hdl.handle.net/11427/28455 | |
| dc.identifier.vancouvercitation | Johnson JE, Wiltsey-Stirman S, Sikorskii A, Miller T, King A, Blume JL, et al. 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. Implementation Science. 2018; http://hdl.handle.net/11427/28455. | en_ZA |
| dc.language.iso | en | |
| dc.publisher | BioMed Central | |
| dc.publisher.department | Division of Paediatric Surgery | en_ZA |
| dc.publisher.faculty | Faculty of Health Sciences | en_ZA |
| dc.publisher.institution | University of Cape Town | |
| dc.rights.holder | The Author(s). | |
| dc.source | Implementation Science | |
| dc.source.uri | https://implementationscience.biomedcentral.com/ | |
| dc.subject.other | Implementation | |
| dc.subject.other | Sustainment | |
| dc.subject.other | Cost-effectiveness | |
| dc.subject.other | Postpartum depression | |
| dc.subject.other | Prevention | |
| dc.subject.other | Public assistance | |
| dc.subject.other | Prenatal care | |
| dc.title | 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 | |
| dc.type | Journal Article | |
| uct.type.filetype | Text | |
| uct.type.filetype | Image |