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

Primary Purpose

Perinatal Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRogram In Support of Moms (PRISM)
MCPAP for Moms
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Perinatal Depression focused on measuring Depression, Pregnancy, Postpartum

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Female
  2. Age 18-55 years
  3. English speaking
  4. 4-36 weeks gestational age (GA) or 2-12 weeks postpartum
  5. Receiving care from one of the 4 participating clinics (2 clinics which will participate in PRISM and 2 with access to MCPAP for Moms)
  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 consent

Exclusion Criteria:

  1. Lack of verbal and written English fluency
  2. Under age 18 or over age 55
  3. Current active substance use disorder
  4. Bipolar disorder diagnosis as determined by the Mini-international Neuropsychiatric Interview (M.I.N.I.)
  5. Psychotic component to illness as determined by the M.I.N.I.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Program In Support of Moms PRISM

    MCPAP for Moms

    Arm Description

    PRISM includes MCPAP for Moms and training, implementation support, and toolkits for Ob/Gyn practices on depression screening, assessment and treatment.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    October 4, 2016
    Last Updated
    April 30, 2018
    Sponsor
    University of Massachusetts, Worcester
    Collaborators
    National Institutes of Health (NIH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02935504
    Brief Title
    PRogram In Support of Moms (PRISM): A Pilot Study
    Acronym
    PRISM-Pilot
    Official Title
    PRogram In Support of Moms (PRISM): A Pilot Group Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Massachusetts, Worcester
    Collaborators
    National Institutes of Health (NIH)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Perinatal Depression
    Keywords
    Depression, Pregnancy, Postpartum

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Program In Support of Moms PRISM
    Arm Type
    Experimental
    Arm Description
    PRISM includes MCPAP for Moms and training, implementation support, and toolkits for Ob/Gyn practices on depression screening, assessment and treatment.
    Arm Title
    MCPAP for Moms
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    PRogram In Support of Moms (PRISM)
    Other Intervention Name(s)
    Rapid Access to Perinatal Psychiatric care in Depression, RAPPID
    Intervention Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    MCPAP for Moms
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Depression Severity
    Description
    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.
    Time Frame
    Baseline to 10-35 weeks follow-up
    Secondary Outcome Measure Information:
    Title
    Provider Fidelity
    Description
    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.
    Time Frame
    Baseline to 1 year follow-up (post intervention)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nancy Byatt, DO, MS, MBA
    Organizational Affiliation
    • UMass Memorial Medical Center/UMass Medical School
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    PRogram In Support of Moms (PRISM): A Pilot Study

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