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

June 7, 2024 updated by: Nancy Byatt, University of Massachusetts, Worcester
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Medical School/UMass Memorial Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female
  2. Age 18-55 years
  3. English speaking
  4. >4 weeks Gestational age (GA) until 4 months postpartum
  5. Receiving care from one of the 10 participating practices (five will participate in PRISM (intervention group) and five will have access to MCPAP For Moms (comparison group)
  6. Edinburgh Postnatal Depression Scale score (EPDS) ≥10
  7. Able to communicate in written and spoken English; and
  8. Cognitively able to participate in informed verbal consent

Exclusion Criteria:

  1. Lack of verbal and written English fluency
  2. Under age 18 or over age 55
  3. substance use disorder as determined by the questions in 4 Ps questionnaire
  4. Screen positive for bipolar disorder via the Mood Disorder Questionnaire (MDQ)
  5. Prisoner
  6. Women participating in 'Moms do care' study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prism Intervention
PRogram In Support of Moms (PRISM)
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
Other Names:
  • Rapid Access to Perinatal Psychiatric care in Depression
Experimental: MCPAP for Moms Intervention
MCPAP for Moms (Massachusetts Child Psychiatry Access Program for Moms)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Edinburgh Postnatal Depression Scale Score (EPDS)
Time Frame: Baseline up to 13 months postpartum
EPDS - Edinburgh Postnatal Depression Scale is an instrument used to measure depression. The score range is 0 to 30. A higher score means more depressed. Depressed perinatal patients receiving care from practices enrolled in PRISM will experience more improvement in depression symptoms than patients receiving care from the MCPAP for Moms practices (2 point difference-of-difference in EPDS).
Baseline up to 13 months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants Initiating Treatment
Time Frame: Baseline to up to 13 months postpartum
Number of depressed perinatal patients receiving care from practices enrolled in PRISM who initiated treatment measured by attendance (i,e. one initial mental health assessment or treatment visit) as compared to women receiving care from practices enrolled in MCPAP for Moms.
Baseline to up to 13 months postpartum
Participants Sustaining Mental Health Treatment
Time Frame: Baseline to up to 13 months postpartum
Sustainment of mental health treatment for depressed perinatal patients receiving care from practices enrolled in PRISM. as measured 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 MCPAP for Moms.
Baseline to up to 13 months postpartum

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Provider/staff fidelity to PRISM intervention
Time Frame: Measured by survey questionnaire at baseline 0-12 months pre-intervention, 0-12 months post intervention, 12-24 months post intervention and final assessment (study completion)
Measured by longitudinal pre and post-intervention data through individual surveys to evaluate depression screening practices, acceptability of screening, perceived gaps in screening/referral supports, and attitudes and practices towards perinatal depression. The post-implementation interviews will measure acceptability of PRISM components.
Measured by survey questionnaire at baseline 0-12 months pre-intervention, 0-12 months post intervention, 12-24 months post intervention and final assessment (study completion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Nancy Byatt, DO, MS, MBA, University of Massachusetts Medical School/UMass Memorial Health Care
  • Principal Investigator: Tiffany A Moore Simas, MD, MPH, MEd, University of Massachusetts Medical School/UMass Memorial Health Care
  • Principal Investigator: Jeroan J Allison, MD, MS, University of Massachusetts Medical School/UMass Memorial Health Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2017

Primary Completion (Actual)

March 16, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimated)

May 3, 2016

Study Record Updates

Last Update Posted (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 7, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H00009163
  • 1U01DP006093 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD sharing plan is as applicable with CDC requirements and policy. All IPD that underlie results in a publication will be shared. Analysis of the data by approved researchers will only be conducted as delineated in the approved proposal. Only the minimum amount of data necessary to accomplish the proposed analysis will be released and must be destroyed after the specified analysis has been completed. All analyses will be subjected to independent verification.

IPD Sharing Time Frame

Starting 6 months after main publication up to a period of 3 years.

IPD Sharing Access Criteria

All researchers who work with the PRISM data will submit a proposal and sign a data-sharing agreement. Researchers will first submit a proposal which will be reviewed by the PRISM Publication Committee. If the proposal is approved, the researcher will sign a data-sharing agreement in which they commit to 1) using the data only for research purposes, 2) keeping the data secure using proper technological precautions, 3) destroying the data after analyses are completed, and 4) only conduct analyses described in the approved proposal.

Our research team will create de-identified analytical datasets and share them with approved researchers as .CSV files that will be transferred by secure encrypted transfer using a secure managed data transfer server.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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