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

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.

Conditions

• Depression, Postpartum

Interventions

BEHAVIORAL

LICF

Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone "booster" meeting.

BEHAVIORAL

HICF

Enhanced implementation plus high intensity will receive will receive everything that the clinics in LICF receive, but at a higher intensity.

BEHAVIORAL

EIAU

Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment,

Sponsors & Collaborators

• Butler Hospital

  collaborator OTHER

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

  collaborator OTHER

• Palo Alto Veterans Institute for Research

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• University of Massachusetts, Worcester

  collaborator OTHER

• Pacific Institute for Research and Evaluation

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Michigan State University

  lead OTHER

Principal Investigators

• Jennifer E Johnson, Ph.D. · Michigan State University

• Raven Miller, M.A. · Michigan State University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-12

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• United States

Study Locations