RecruitingNot ApplicableNCT06849869

Collaborative Care Model for Perinatal Wellness Support Services - Population-Level Equity-Centered Systems Change

Collaborative Care Model for Perinatal Depression Support Services -- Population-Level Equity-Centered Systems Change (COMPASS-PLUS): a Hybrid Type 2 Cluster Randomized Trial


Sponsor

Women and Infants Hospital of Rhode Island

Enrollment

14,820 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The collaborative care model (CCM) is a health services intervention that integrates mental health care in primary care settings. The goal of this study is to adapt the CCM to the perinatal care context, including community co-designed adaptations to enhance health equity (COMPASS+). The main objectives of the study are to: 1. Evaluate the effect of COMPASS+ on depression symptom outcomes. Specifically we will evaluate population-level depression symptom trajectories and the prevalence of suicidal ideation among. We will also measure rates of depression response and remission for those who have elevated screen scores (i.e., PHQ9 ≥ 10) 2. Adapt, optimize, and evaluate COMPASS+ implementation strategies to the unique context of perinatal care and evaluate implementation outcomes. The RE-AIM framework will be used to evaluate implementation outcomes (acceptability, appropriateness, feasibility, and fidelity). We hypothesize that variability in effectiveness outcomes will be attributable to variability in fidelity to the implementation strategies or in implementation outcomes. 3. Identify the effect of COMPASS+ on perinatal depression and implementation outcomes across racial and ethnic subgroups.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

  • all pregnant and postpartum people receiving care at participating sites
  • age \> 17 years

Exclusion Criteria1

  • age \< 18 years

Interventions

BEHAVIORALCOMPASS+

COMPASS+ is centered around the integration of a care manager (a licensed mental health clinician) who provides mental health supports (e.g. short-term therapy) and symptom monitoring to perinatal patients. The care manager works closely with the patient and obstetric clinician to create a treatment plan based on the patient's preferences and needs. The care manager also utilizes a care registry to send monthly mental health screeners to patients and track their symptoms. The care manger meets weekly with the obstetric clinician and a consulting psychiatrist to review and modify treatment plans as needed. The care manager services are available throughout pregnancy and up to one year postpartum.


Locations(1)

Women and Infants Hospital

Providence, Rhode Island, United States

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NCT06849869


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