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

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ClinicalTrials.gov Identifier: NCT02760004
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Nancy Byatt, University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: PRogram In Support of Moms (PRISM) Behavioral: Enhanced Usual Care group (Access to MCPAP for Moms) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology Clinics
Study Start Date : April 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prism Intervention
PRogram In Support of Moms (PRISM)
Behavioral: PRogram In Support of Moms (PRISM)
  • 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 Name: Rapid Access to Perinatal Psychiatric care in Depression

Experimental: Enhanced Usual Care
Enhanced Usual Care group (Access to MCPAP for Moms)
Behavioral: Enhanced Usual Care group (Access to 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




Primary Outcome Measures :
  1. Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 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). ]
    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).


Secondary Outcome Measures :
  1. Mental Health Utilization Questionnaire [ Time Frame: 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. ]
    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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 12 participating practices (six will participate in PRISM (intervention group) and six will have access to enhanced usual care (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. Ongoing substance abuse
  4. Screen positive for bipolar disorder via the MDQ (Mood Disorder Questionnaire)
  5. 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760004


Contacts
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Contact: Padma Sankaran, MA 508-856-8505 padma.sankaran@umassmed.edu
Contact: Linda Brenckle, MS, RD, PMP 508-856-8491 Linda.brenckle@umassmed.edu

Locations
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United States, Massachusetts
UMass Medical School/UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Padma Sankaran, MA    508-856-8505    Padma.Sankaran@umassmed.edu   
Sponsors and Collaborators
University of Massachusetts, Worcester
Centers for Disease Control and Prevention
Investigators
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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

Additional Information:
Publications:
Agency for Healthcare Research and Quality. Efficacy and Safety of Screening for Postpartum Depression. Rockville, MD: Agency for Healthcare Research and Quality 2013.
Weathers F, Litz B, Huska J, Keane T. PTSD checklist—civilian version. In. Boston: Nation Center for PTSD. Behavioral Sciences Division. ; 1994
Little R. Statistical Analysis with Missing Data. New York: John Wiley and Sons; 1987
Karlson K, Holm A. Decomposing primary and secondary effects: A new decomposition method. Research in Social Stratification and Mobility 2011;29:221-37.

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Responsible Party: Nancy Byatt, Associate Professor of Psychiatry and Obstetrics & Gynecology, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT02760004     History of Changes
Other Study ID Numbers: H00009163
1U01DP006093 ( U.S. NIH Grant/Contract )
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nancy Byatt, University of Massachusetts, Worcester:
Depression

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms