PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology Clinics

Study Overview
=================
Brief Summary
-----------------
The primary goal of this study is to develop, evaluate, and share a new low-cost program for Obstetrics/Gynecology (Ob/Gyn) practices which will help to improve depression treatment for women during pregnancy and after childbirth.

Detailed Description
-----------------
Upwards of 1 in 5 women suffer from depression during pregnancy or within a year after giving birth. It has negative effects on birth outcomes, infant attachment, and children's behavior/development. Maternal suicide causes 20% of postpartum deaths in depressed women. Although the vast majority of perinatal women are amenable to being screened for depression, screening alone does not improve treatment rates or patient outcomes. Ob/Gyn practices need supports in place to adequately address depression in their patient populations. Thus, the Investigators developed and pilot tested the PRogram In Support of Moms (PRISM), to create a comprehensive intervention that is proactive, multifaceted, and practical. PRSIM aims to improve perinatal depression treatment and treatment response rates through: (1) access to immediate resource provision/referrals and psychiatric telephone consultation for Ob/Gyn providers; (2) clinic-specific implementation of stepped care, including training support and toolkits; and, (3) proactive treatment engagement, patient monitoring, and stepped treatment response to depression screening/assessment. PRISM builds on a low-cost and widely disseminated population-based model for delivering psychiatric care in primary care settings developed by our team. Because it uses existing infrastructure and resources, PRISM, has the potential to be feasible, sustainable and transportable to other practice settings. The Investigators will compare PRISM vs. enhanced usual care (access to resource provision/referrals and psychiatric telephone consultation) in a clinical trial in which Investigators will randomize 12 Ob/Gyn practices to either PRISM or enhanced usual care intervention. Provider and staff participants will participate in either PRISM or enhanced usual care, depending on what intervention their practice is assigned to. The Investigators will compare the effectiveness of PRISM vs. enhanced usual care to improve depression severity and treatment participation in pregnancy through 12 months postpartum among 300 patients (n=150/group, 25 per clinic). The Investigators will also determine change in knowledge, attitudes, and practices toward depression screening and treatment in the PRISM group compared to enhanced usual care group.

Official Title
-----------------
PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology Clinics

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: PRogram In Support of Moms (PRISM)
* Behavioral: Enhanced Usual Care group (Access to MCPAP for Moms)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age 18-55 years English speaking >4 weeks gestational age (GA) until 4 months postpartum Receiving care from one of the 12 participating practices (six will participate in PRISM (intervention group) and six will have access to enhanced usual care (comparison group) Edinburgh Postnatal Depression Scale score (EPDS) ≥10 Able to communicate in written and spoken English; and Cognitively able to participate in informed verbal consent Exclusion Criteria: Lack of verbal and written English fluency Under age 18 or over age 55 Ongoing substance abuse Screen positive for bipolar disorder via the MDQ (Mood Disorder Questionnaire) Prisoner Inclusion criteria for provider participants: Prenatal care providers and support staff including physician, advanced practice nurse, nurse, patient care assistant, psychologists and social workers serving women at the recruited clinical sites Exclusion criteria for provider participants: Not a prenatal care provider or support person as indicated above from one of the study designated sites

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prism Intervention<br>PRogram In Support of Moms (PRISM) | Behavioral: PRogram In Support of Moms (PRISM)<br>* PRogram In Support of Moms Toolkit with Stepped Care Algorithms Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform Customization of depression screening for each practice Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS) Employ psychoeducation and Motivational Interviewing to engage patients with depression medical assistant champion and psychiatrist contact bi-weekly to review cases Stepped care treatment to depression screening/assessment<br>* Other names: Rapid Access to Perinatal Psychiatric care in Depression;|
| Experimental: Enhanced Usual Care<br>Enhanced Usual Care group (Access to MCPAP for Moms) | Behavioral: Enhanced Usual Care group (Access to MCPAP for Moms)<br>* 30-60 minute presentation on perinatal depression Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation Access to assessment and treatment protocols in Provider Toolkit Resource provision/referrals<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edinburgh Postnatal Depression Scale (EPDS) | Depressed perinatal patients receiving care from practices enrolled in PRISM will experience more improvement in depression symptoms than patients receiving care from the enhanced usual care practices (2 point difference-of-difference in EPDS). | The change in EPDS scores from baseline (0 -20 weeks GA, 20-40 weeks GA or 0-12 weeks pp) to final assessment (11-13 months pp) will be compared between the 2 arms (enhanced usual care vs PRISM). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Health Utilization Questionnaire | Depressed perinatal patients receiving care from practices enrolled in PRISM will have improved treatment initiation and sustainment (as measured by attendance and one initial mental health assessment or treatment visit and an average ≥1 mental health visit every 1 month until remission of symptoms or study assessment) as compared to women receiving care from practices enrolled in enhanced usual care. | 4-20 wks GA, 20-40 wks GA, 0-12 wks pp, 5-7 mos pp, 11-13 mos pp, Depending on when recruited the Mental Health Utilization Questionnaire will be administered 3 to 5 times throughout the study. Recruitment can happen in the first 3 time periods. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression