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

NCT06849869 | Recruiting DMC

• 2 other identifiers: 2100211R01NR021126
• Study Type: interventional
• Target: 14,820
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.Identify the effect of COMPASS+ on perinatal depression and implementation outcomes across racial and ethnic subgroups.

Conditions

Perinatal Mental Health

Keywords

health services interventions; mental health; collaborative care model; compass+; perinatal care

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire-9 (PHQ9) trajectories

  Depression symptom trajectories will be measured using the PHQ9 PHQ9 scores will be collected by the perinatal practice in each trimester and again postpartum for all pregnant and postpartum people receiving prenatal care. PHQ9 scores will also be collected by the care manager every 30 days for those referred to the COMPASS+ program until one year postpartum. Each of these scores will be entered into the trajectory analysis.

  enrollment in prenatal care through end of one year postpartum

Secondary Outcomes (7)

• Suicidal ideation as assessed by the PHQ9

  enrollment in prenatal care through end of one year postpartum

• Depression symptom response: Number of participants with a PHQ9≥10 who achieve a 50% reduction in PHQ9

  enrollment in prenatal care through end of one year postpartum

• Depression symptom remission: Number of participants with a PHQ9≥10 who achieve a PHQ9<10

  enrollment in prenatal care through end of one year postpartum

• Acceptability measured by the Acceptability of Intervention Measure (AIM)

  early implementation (1-2 months), mid-implementation (6-7 months), and sustainment (12-13 months)

• Appropriateness measured using the Intervention Appropriateness Measure (IAM)

  early implementation (1-2 months), mid-implementation (6-7 months), and sustainment (12-13 months)

Study Arms (2)

COMPASS+

EXPERIMENTAL

COMPASS+ services are embedded into the perinatal practice. COMPASS+ includes mental health support services and monitoring by a behavioral health care manager, a patient registry to track participant response to treatment, and weekly team huddles supervised by a perinatal psychiatrist to discussed new participants in the program or individuals who are not symptomatically improving. Patients are eligible for referral to COMPASS+ during pregnancy through one year postpartum.

Behavioral: COMPASS+

Usual care

NO INTERVENTION

Perinatal care practices support the mental health needs of patients providing usual care workflows at their clinic (e.g. screening for depression and anxiety symptoms in each trimester and postpartum, referring patients to community resources)

Interventions

COMPASS+ BEHAVIORAL

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.

COMPASS+

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all pregnant and postpartum people receiving care at participating sites, who reach a gestational age of 20 or more weeks
• age \> 17 years

You may not qualify if:

• age \< 18 years
• all pregnant and postpartum people receiving care at participating sites, who do not reach a gestational age of 20 or more weeks

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead
• Brown University: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Women and Infants Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Emily Miller, MD

CONTACT

401- 274-1100; emmiller@wihri.org

Andrea Chu

CONTACT

andrea_chu@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized stepped wedge design

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 27, 2025
• Study Start: June 3, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-02

Locations

US (1)