NCT02760004

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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. PRISM 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. MCPAP for Moms which provides access to resource provision/referrals and psychiatric telephone consultation, in a clinical trial in which Investigators will randomize 10 Ob/Gyn practices to either PRISM or MCPAP for Moms (Massachusetts Child Psychiatry Access Program for Moms) - intervention. Patient participants will participate in either PRISM or MCPAP for Moms, depending on what intervention their practice is assigned to. The Investigators will compare the effectiveness of PRISM vs. MCPAP for Moms to improve depression severity and treatment participation in pregnancy through 13 months postpartum among 340 patients (n=170/group).

Conditions

• Depression

Interventions

Type	Name	Description
BEHAVIORAL	PRogram In Support of Moms (PRISM)	* Access to MCPAP for Moms * 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
BEHAVIORAL	MCPAP for Moms	* 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

Timeline

• Start date: 2017-10-11
• Primary completion: 2022-03-16
• Completion: 2022-05-31
• First posted: 2016-05-03
• Last updated: 2024-06-10
• Results posted: 2024-06-10

Locations

1 site across 1 country: United States