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

Study acronym: COMPASS+
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Jun 30, 2028 → Jan 30, 2029
See other at-risk trials from Women and Infants Hospital of Rhode Island

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 30, 2028 to Jan 30, 2029
    • Study completion pushed from Jun 30, 2028 to Mar 30, 2029
    v4
  2. Primary and study completion dates: Jun 2028 to Jun 30, 2028
    • Start date: Feb 24, 2025 to Jun 3, 2024
    • Eligibility criteria expanded, about 32 words
    v3
  3. Start date: Feb 4, 2025 to Feb 24, 2025
    • Secondary endpoints: details revised at 1 of 7 entries
    • Study description revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06849869
Lead Sponsor Women and Infants Hospital of Rhode Island
Collaborators: Brown University, National Institute of Nursing Research (NINR)
Conditions
(from sponsor)		 Perinatal Mental Health
Related terms Psychological Well-Being
Enrollment 14,820 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov