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

U

University of Massachusetts, Worcester

Status

Completed

Conditions

Depression

Treatments

Behavioral: Enhanced Usual Care group (Access to MCPAP for Moms)
Behavioral: PRogram In Support of Moms (PRISM)

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT02760004
H00009163
1U01DP006093 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

312 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female
  • Age 18-55 years
  • English speaking
  • >4 weeks gestational age (GA) until 4 months postpartum
  • 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)
  • Edinburgh Postnatal Depression Scale score (EPDS) ≥10
  • Able to communicate in written and spoken English; and
  • Cognitively able to participate in informed verbal consent

Exclusion criteria

  • Lack of verbal and written English fluency
  • Under age 18 or over age 55
  • Ongoing substance abuse
  • Screen positive for bipolar disorder via the MDQ (Mood Disorder Questionnaire)
  • 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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

312 participants in 2 patient groups

Prism Intervention
Experimental group
Description:
PRogram In Support of Moms (PRISM)
Treatment:
Behavioral: PRogram In Support of Moms (PRISM)
Enhanced Usual Care
Experimental group
Description:
Enhanced Usual Care group (Access to MCPAP for Moms)
Treatment:
Behavioral: Enhanced Usual Care group (Access to MCPAP for Moms)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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