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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWomen and Infants Hospital of Rhode Island

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

age > 17 years

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

14,820 Participants
are divided into 2 treatment groups
Group A: COMPASS+Experimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

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.

Time frame
enrollment in prenatal care through end of one year postpartum

Secondary outcomes

1

Suicidal ideation as assessed by the PHQ9

Suicidal ideation is defined as a PHQ-9 question 9 score \> 0 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

Time frame
enrollment in prenatal care through end of one year postpartum
2

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

Among participants who have an elevated screen for depression (i.e., PHQ-9≥10), the proportion of participants who achieve response (50% reduction in PHQ-9 compared to baseline) in their depression symptoms.

Time frame
enrollment in prenatal care through end of one year postpartum
3

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

Among participants who have an elevated screen for depression (i.e., PHQ-9≥10), the proportion of participants who achieve remission (PHQ-9 \< 10) in their depression symptoms.

Time frame
enrollment in prenatal care through end of one year postpartum
4

Acceptability measured by the Acceptability of Intervention Measure (AIM)

The AIM will be completed by clinician champions and clinic stakeholders within each practice

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

Other outcomes

Sponsors and contacts

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Women and Infants Hospital of Rhode Island

Lead sponsor

Brown University

Collaborator

National Institute of Nursing Research (NINR)

Collaborator