Clinical trial NCT06849869: Collaborative Care Model for Perinatal Wellness Support Services - Population-Level Equity-Centered Systems Change
Official title: Collaborative Care Model for Perinatal Depression Support Services -- Population-Level Equity-Centered Systems Change (COMPASS-PLUS): a Hybrid Type 2 Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perinatal Mental Health
Keywords: health services interventions
mental health
collaborative care model
compass+
perinatal care
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: Brown University
name: National Institute of Nursing Research (NINR)
First posted: 2025-02-27
Enrollment: 14820
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: randomized stepped wedge design
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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.

Detailed description: One in five women experiences perinatal depression (PD), defined as an episode of major depressive disorder, during pregnancy or postpartum. PD can have devastating consequences for the individual, family, and community. In its most extreme form, PD can lead directly to suicide, a leading contributor to maternal mortality (MM). Untreated PD also indirectly contributes to severe maternal morbidity (SMM) and MM via associated behavioral risk factors. Despite evidence-based recommendations for PD, only 3-5% of women with PD will achieve remission of their depressive symptoms. Gaps in addressing social determinants of mental health (SDoMH), including structural racism and discrimination, contribute to the lack of success in treating PD, particularly among pregnant and postpartum individuals. Our team has identified marked racial disparities in both screening for PD and in its actual treatment.

In contrast to the existing, but failing, systems for PD care, the collaborative care model (CCM) is an established integrated supportive care intervention built on four equity-centered core principles: 1) patient-centered team care, 2) population-based care, 3) measurement-optimized treatment, and 4) evidence-based care. In primary care settings, over 80 randomized trials have demonstrated the efficacy of the CCM for improving depression outcomes. However, CCM is not broadly utilized in obstetric care. There are two major reasons for this gap from evidence to practice. The first is the lack of rigorous and generalizable evidence to support the impact of the perinatal CCM (pCCM) on population-level depression outcomes. Second, substantive differences between obstetric and primary care, which occur at the patient, provider, and system-levels, require tailored implementation strategies for pCCM.

Our prior formative research generated an optimized package of strategies for effectively implementing pCCM within diverse perinatal care settings through COMPASS (Collaborative Care Model for Perinatal Depression Support Services). We demonstrated that COMPASS improves the steps necessary for PD care, including screening and recommending treatment for PD. Moreover, our research has demonstrated that COMPASS reduces racial disparities in the steps required for PD care. Nonetheless the small samples sizes of the available studies preclude robust analyses of impact on the racial and ethnic disparities in PD outcomes. The lack of a rigorous approach to identifying and addressing SDoMH renders even the successes of COMPASS inadequate.

The critical need to equitably and adequately care for mental health conditions in pregnancy and postpartum informs the creation of COMPASS-PLUS (Collaborative Care Model for Perinatal Depression Support Services - Population-Level Equity-Centered Systems Change) (herein referred to as COMPASS+). COMPASS+ is built upon the foundations of COMPASS and embeds an anti-racist approach to addressing SDoMH via 1) a health equity advocate and 2) race and ethnicity-centered support groups for pregnancy and postpartum people, irrespective of any identified mental health needs. We propose a multi-site hybrid type 2 implementation effectiveness stepped wedge cluster randomized trial to test our central hypothesis that COMPASS+ is more effective and equitable than standard care for PD outcomes. To test this hypothesis, six diversely structured clinics across Rhode Island will be randomized to receive COMPASS+ or usual care to address the following specific aims:

Aim 1: Evaluate the effect of COMPASS+ on depression symptom severity and rate of depression response and remission. We hypothesize that implementing COMPASS+ will improve Patient Health Questionnaire 9 (PHQ9) scores (primary outcome) and reduce suicidal ideation across the study population. We hypothesize that implementing COMPASS+ will increase depression response (50% reduction in PHQ9 compared to baseline) and depression remission (PHQ9 ≤ 9) among those with PD.

Aim 2: To 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.

Aim 3: Identify the effect of COMPASS+ on perinatal depression and implementation outcomes across racial and ethnic subgroups. We hypothesize that COMPASS+ will reduce Latinx and Black versus White disparities in COMPASS+ reach and in the aforementioned PD outcomes. A subset of women (n=30) will undergo qualitative interviews regarding their experiences with COMPASS+ to evaluate racial and ethnic differences in acceptability and accessibility, using the RE-AIM framework.

The expected outcome of this project is to generate the empiric evidence needed to understand the effect of the CCM in general, and COMPASS+ specifically, on PD-related outcomes. We will generate an optimized package of successful implementation strategies for COMPASS+ to promote broad dissemination. Findings from this trial will be broadly applicable to women throughout the United States who face challenges in receiving adequate mental health care. Moreover, our results will have a substantial impact on identifying and addressing the critical factors that contribute to racial and ethnic disparities in PD-related outcomes.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* age \< 18 years

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ9) trajectories
timeFrame: enrollment in prenatal care through end of one year postpartum
Secondary outcomes:
measure: Suicidal ideation as assessed by the PHQ9
timeFrame: enrollment in prenatal care through end of one year postpartum
measure: Depression symptom response: Number of participants with a PHQ9≥10 who achieve a 50% reduction in PHQ9
timeFrame: enrollment in prenatal care through end of one year postpartum
measure: Depression symptom remission: Number of participants with a PHQ9≥10 who achieve a PHQ9<10
timeFrame: enrollment in prenatal care through end of one year postpartum
measure: Acceptability measured by the Acceptability of Intervention Measure (AIM)
timeFrame: early implementation (1-2 months), mid-implementation (6-7 months), and sustainment (12-13 months)
measure: Appropriateness measured using the Intervention Appropriateness Measure (IAM)
timeFrame: early implementation (1-2 months), mid-implementation (6-7 months), and sustainment (12-13 months)
measure: Feasibility measured using the Feasibility of Intervention Measure (FIM)
timeFrame: early implementation (1-2 months), mid-implementation (6-7 months), and sustainment (12-13 months)
measure: Maintenance measured using the Clinical Sustainability Assessment Tool (CSAT)
timeFrame: 12-13 months after implementation at each site
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
Study officials:
References: