Minimum Intervention to Maintain a Postpartum Depression Prevention Program in Clinics Serving Low-income Women

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.

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: