Clinical trial NCT03267563: Minimum Intervention to Maintain a Postpartum Depression Prevention Program in Clinics Serving Low-income Women
Official title: Implementing to Sustain: Determining the Minimum Necessary Intervention to Maintain a Postpartum Depression Prevention Program (ROSE) in Clinics Providing Prenatal Services to Low-income Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Keywords: prevention
implementation
sustainment
perinatal
pregnancy
postpartum
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Butler Hospital
name: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
name: Palo Alto Veterans Institute for Research
name: University of Rochester
name: University of Massachusetts, Worcester
name: Pacific Institute for Research and Evaluation
First posted: 2017-08-30
Enrollment: 791
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential, multiple assignment, randomized trial (SMART) design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Postpartum depression (PPD) is common and can have lasting consequences for mother and child. ROSE is an intervention to prevent PPD, delivered during pregnancy in outpatient prenatal settings. ROSE has been found to significantly reduce cases of PPD in multiple randomized trials in community prenatal settings with racially and ethnically diverse low-income pregnant women. Requests for ROSE training and recent policy changes supporting payment for comprehensive perinatal services to underserved populations suggest a context ripe for embedding ROSE in prenatal clinics long-term. Given the need for return on investment studies about sustainment efforts, we propose a Sequential Multiple Assignment Randomized (SMART) Trial of the effectiveness and cost-effectiveness of a stepwise approach to sustainment of ROSE in 90 outpatient clinics providing prenatal care to pregnant women on public assistance in 6 U.S. states. In Year 1, all 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, 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 found to be at risk at subsequent assessments, they will be randomized to either (1) EIAU + LICF only, or (2) high-intensity coaching and feedback (HICF). Additional study follow-up interviews will occur at 18, 24, and 30 months, but no implementation intervention will occur after 18 months. Outcomes include: 1. Sustainment of core program elements at each time point and total length of time ROSE services were provided and were provided with at least moderate fidelity. 2. Health impact (PPD rates over time at each clinic) and reach. 3. ROI (costs, cost-offsets, and cost-effectiveness) of each sustainment step. Hypothesized mechanisms include sustainment of clinical and organizational capacity to deliver core elements, and engagement/ownership. The study will also examine predictors, tailoring variables, and implementation processes to determine which kinds of clinics need which level of sustainment support and when. To our knowledge, this study will be the first randomized trial evaluating the ROI of a stepped approach to sustainment, a critical unanswered question in implementation science.

Detailed description: A recent expert consensus report concluded that, "Little is known about how well or under what conditions health innovations are sustained and their gains maintained once they are put into practice. Implementation science typically focuses on uptake by early adopters. The later-stage challenges of sustaining evidence-supported interventions receive too little attention." This report placed high priority on conducting return on investment (ROI) studies to determine how much is gained when effective programs are sustained, and cost-benefit trade-offs for effort required to sustain.1 Information is especially needed for preventive behavioral health interventions for adults in outpatient medical (e.g., primary care; OBGYN) settings.

Postpartum depression (PPD) is common and can have serious and lasting consequences for mother and child, including maternal increased risk for suicide, compromised functional status, and adverse infant developmental outcomes. Prevalence of PPD is \~13% in the 12 weeks after childbirth, with rates up to 50% among low-income women, who are especially vulnerable to the consequences of PPD. Outpatient clinics offering prenatal care are an opportune place to deliver PPD prevention services because most women will visit while pregnant. Recent guidelines suggest that prenatal clinics should screen for PPD after birth and refer once it is identified. Unfortunately, prenatal clinics do not routinely do anything to prevent PPD from occurring.

The ROSE Program (Reach Out, Stay Strong, Essentials for mothers of newborns) is a small-group intervention to prevent PPD that is delivered during pregnancy in outpatient prenatal settings. ROSE is the only PPD preventative intervention that (1) has been found to significantly reduce cases of PPD in multiple randomized trials, and (2) has been tested in community prenatal settings with racially and ethnically diverse low income pregnant women. ROSE consists of four 90-minute group sessions and a 50-minute individual booster session after delivery. Requests for ROSE training in Philadelphia and nationwide in Japan, and recent policy changes supporting payment for comprehensive perinatal services (including behavioral health care) to underserved populations all suggest a context ripe for embedding ROSE in prenatal clinics long-term. Given the need for ROI studies about sustainment efforts and that ROSE is well-positioned for implementation and sustainment research, we propose a Sequential Multiple Assignment Randomized (SMART) Trial of the effectiveness and cost-effectiveness of a stepwise approach to sustainment of ROSE in 90 outpatient clinics providing prenatal care to pregnant women on public assistance accross the US. Our conceptual framework comes from RE-AIM and a review on sustainment by Co-I Wiltsey-Stirman,3 with sustainment strategies based on the Replicating Effective Programs (REP) framework. All clinics will receive enhanced implementation as usual (EIAU; initial training + tools for sustainment). Clinics will be assessed using surveys and qualitative interviews 9 times over 2.5 years after receiving EIAU. Clinics at risk for failure to sustain operationally (defined as no ROSE intervention in 3 months and none planned) and/or clinically (defined as low fidelity to ROSE core elements) will be randomized to receive additional sustainment support for up to 18 months after baseline. 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 to receive either: (1) no additional implementation support (EIAU only), or (2) EIAU plus low-intensity (every 3 months) coaching and feedback (LICF). If clinics receiving LICF are still at risk at subsequent monitoring periods, they will be randomized to (1) EIAU + LICF only, or (2) EIAU + LICF + high-intensity (monthly) coaching and feedback (HICF). Additional study follow-up interviews will occur at 18, 24, and 30 months, but no implementation intervention will occur after 18 months. We will assess costs and benefits of sustainment strategies. Aims are to:

Compare effectiveness of each sustainment step for the following final and proximal OUTCOMES:

1. Sustainment of core program elements at each time point, and total length of time in weeks that: (i) any ROSE services were provided, and (ii) were provided with adequate fidelity to core elements (primary).
2. Health impact (e.g., PPD rates over time at each clinic) and reach (number of patients enrolled in and completing the ROSE program).
3. Return on Investment (costs and cost-effectiveness of each sustainment step).
4. Hypothesized mechanisms include sustainment of: (a) clinical and organizational capacity to deliver core elements, and (b) a sense of engagement/ownership by key clinic staff, Examine predictors and processes to determine which kinds of clinics need which level of support.
5. Explore which clinic characteristics (e.g., organizational and state policy contexts) and hypothesized mechanisms (Aim 4) are associated with best sustainment to determine tailoring variables for choosing/sequencing EIAU, LICF, HICF in the future.
6. Document implementation/sustainment effort processes, their timing relative to desired outcomes, critical incidents to explore factors most related to sustainment after accounting for hypothesized mechanisms.

To our knowledge, this study will be the first randomized trial evaluating the ROI of a stepped approach to sustainment, a critical unanswered question in implementation science. The study will also examine a set of strategies to promote sustainment of an effective PPD prevention intervention for low-income women, reducing negative consequences for mother and child. The proposal directly addresses the goal of PAR-16-238 to conduct longitudinal studies on "factors that contribute to the sustainability of evidence-based interventions," to test strategies to improve quality of care among underserved populations, examine mediators and moderators, and examine cost-effectiveness or other economic outcomes. Thus, the study will advance implementation science, knowledge of implementation science mechanisms, and clinical care for an at-risk population.

Eligibility criteria: Study enrollment and randomization takes place at the clinic level. Study participants will be clinical and operational staff representatives of participating clinics.

To be included in the study, clinics will:

* provide outpatient prenatal services
* estimate that at least 50% of their pregnant patients receive some kind of public assistance (such as federal or state assistance in the form of cash assistance such as Temporary Assistance for Needy Families \[TANF\], food stamps, subsidized housing, and/or health care such as Medicaid)
* have at least 10 new pregnant women per month on average (i.e., enough patient flow to run ROSE)
* agree to study procedures.

Exclusion Criteria:

* None

Primary outcomes:
measure: Sustainment of core program elements
timeFrame: Measured at 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline
Secondary outcomes:
measure: Total length of time any ROSE services were offered
timeFrame: Measured at 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline
measure: Health impact: Postpartum depression (PPD) rates over time at each clinic
timeFrame: Quarterly over 30 months
measure: ROSE Intervention reach
timeFrame: Quarterly over 30 months
measure: Cost-effectiveness
timeFrame: Measured at 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline
Other outcomes:
measure: Hypothesized mechanism: Sustainment of clinical and organizational capacity to deliver core elements
timeFrame: Measured at baseline, 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline
measure: Hypothesized mechanism: Sustainment of a sense of engagement/ownership by key clinic staff.
timeFrame: Measured at baseline, 3, 6, 9, 12, 15, 18, 24, and 30 months after baseline
Locations:
city: Flint
country: United States
facility: Michigan State University
state: Michigan
Study officials:
affiliation: Michigan State University
name: Jennifer E Johnson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan State University
name: Raven Miller, M.A.
role: STUDY_DIRECTOR
References:
citation: Johnson JE, Wiltsey-Stirman S, Sikorskii A, Miller T, King A, Blume JL, Pham X, Moore Simas TA, Poleshuck E, Weinberg R, Zlotnick C. 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. Implement Sci. 2018 Aug 22;13(1):115. doi: 10.1186/s13012-018-0807-9.