PRogram In Support of Moms (PRISM): A Pilot Study

Study Overview
=================
Brief Summary
-----------------
The primary goal of this study is to evaluate the PRogram In Support of Moms (PRISM) that aims to improve women's access to and participation in perinatal depression treatment and thereby improve depression outcomes

Detailed Description
-----------------
Major depressive disorder continues to be the leading cause of disability among women of reproductive age and major public health concern. 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, behavior and development. Maternal suicide causes 20% of postpartum deaths in depressed women. Although the majority of women are amenable to depression screening, screening alone does not improve treatment entry or outcome. Despite the availability of effective evidence-based treatments and frequent contact with obstetric providers, less than one-third of women who screen positive for depression receive treatment. Ob/Gyn practices need supports in place to adequately address depression in their patient populations. Thus, the Investigators developed a program called PRogram In Support of Moms (PRISM) that aims to leverage existing roles and resources to target patient, provider, and system level barriers to perinatal depression treatment. PRISM aims to improve perinatal depression treatment and treatment response rates through: (1) access to 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. Four practices were randomly assigned to PRISM versus an active comparison group called MCPAP for Moms which is a state-wide telephonic perinatal psychiatry program. The Investigators will compare the effectiveness of PRISM vs. MCPAP for Moms to improve depression severity and treatment participation in pregnancy through 3 months postpartum among patients.

Official Title
-----------------
PRogram In Support of Moms (PRISM): A Pilot Group Randomized Controlled Trial

Conditions
-----------------
Perinatal Depression

Intervention / Treatment
-----------------
* Behavioral: PRogram In Support of Moms (PRISM)
* Behavioral: MCPAP for Moms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age 18-55 years English speaking 4-36 weeks gestational age (GA) or 2-12 weeks postpartum Receiving care from one of the 4 participating clinics (2 clinics which will participate in PRISM and 2 with access to MCPAP for Moms) Edinburgh Postnatal Depression Scale score (EPDS) ≥10 Able to communicate in written and spoken English; and Cognitively able to participate in informed consent Exclusion Criteria: Lack of verbal and written English fluency Under age 18 or over age 55 Current active substance use disorder Bipolar disorder diagnosis as determined by the Mini-international Neuropsychiatric Interview (M.I.N.I.) Psychotic component to illness as determined by the M.I.N.I.

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: Program In Support of Moms PRISM<br>PRISM includes MCPAP for Moms and training, implementation support, and toolkits for Ob/Gyn practices on depression screening, assessment and treatment. | Behavioral: PRogram In Support of Moms (PRISM)<br>* PRISM Intervention Provider and staff training Webinar Delivered in person Engage providers - Registered Nurses (RN) and Patient Care Assistants (PCA) and ensure they attend: Toolkit Care coordination Psychiatric consultation Implementation support Engage clinic leaders and staff Identify leadership group and prepare for change Assess readiness to implement PRISM Identify steps to achieve goals Implement PRISM components into the clinic Support, encourage and sustain change Office prompts Screening procedures Plus all MCPAP for Moms intervention<br>* Other names: RAPPID;|
| Active Comparator: MCPAP for Moms<br>Consists of access to psychiatric consultation and resources and referrals through MCPAP for Moms - MCPAP for Moms is available free of charge to all Ob/Gyn practices in Massachusetts. | Behavioral: MCPAP for Moms<br>* MCPAP for Moms Provider and staff training Delivered via web RN and PCA admin staff recommended to attend 30-60 minute presentation on perinatal depression Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns Access to one-time face-face evaluation with patient by a MCPAP for Moms psychiatrist for assessment and treatment recommendations for Ob/Gyn provider Access to Provider Toolkit which includes assessment and treatment protocols (available at www.mcpapformoms.org) Resource provision/referrals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Severity | To compare changes in depression severity as measured by Edinburgh Postnatal Depression Scale (EPDS) from baseline to follow-up (10-35 weeks) among pregnant and postpartum women in PRISM versus MCPAP for Moms. | Baseline to 10-35 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provider Fidelity | To determine change in knowledge, attitudes, and practices as measured by S-KAP toward depression screening and treatment from baseline (pre implementation) to 1 year follow-up (post implementation) among providers in PRISM versus MCPAP for Moms practices. | Baseline to 1 year follow-up (post intervention) | 

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