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Recruiting Not applicable NCT06849869

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

No applicable phase (e.g. observational)
Conditions: Perinatal Mental Health

Sponsor: Women and Infants Hospital of Rhode Island

trial.available_in: БГ
Overview
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.
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
Who can participate
Inclusion Criteria: * all pregnant and postpartum people receiving care at participating sites, who reach a gestational age of 20 or more weeks * age \> 17 years Exclusion Criteria: * 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
Interventions
COMPASS+
BEHAVIORAL
Locations 1
United States (1)
Women and Infants Hospital
Providence , Rhode Island
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
03.06.2024
Completion date
30.06.2028
Registry ID
NCT06849869
Source
clinicaltrials.gov
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