Abstract
BackgroundMore 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.MethodsAll 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.DiscussionThis 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 registrationClinicaltrials.gov, NCT03267563. Registered June 14, 2018.
Highlights
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
We have identified a high-burden condition (PPD), identified an effective intervention that fits prenatal clinics (ROSE), and packaged the intervention
At the first time period at which a clinic is determined to be at risk, that clinic will be randomized in a 3.8:1 ratio (Fig. 2) to receive either (1) the addition of low-intensity coaching and feedback (LICF), or (2) no additional implementation support (EIAU only)
Summary
Preliminary studies Past work on ROSE ROSE is effective at reducing PPD cases among lowincome women in community settings (see Table 1). Clinics that are determined to be at-risk for operational (defined as no ROSE intervention in 3 months and none planned) and/ or clinical (defined as less than 75% fidelity to ROSE core elements) failure to sustain at subsequent assessments up to 15 months will be randomized to receive additional support. At the first time period at which a clinic is determined to be at risk (i.e., at 3, 6, 9, 12, or 15 months), that clinic will be randomized in a 3.8:1 ratio (Fig. 2) to receive either (1) the addition of low-intensity (every 3 months) coaching and feedback (LICF), or (2) no additional implementation support (EIAU only). Core elements (delivered/should have been delivered over 3 months) Session √list
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