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

NCT ID: NCT02935504

Last Updated: 2018-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-06-30

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.

Conditions

Perinatal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Program In Support of Moms PRISM

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

Group Type: EXPERIMENTAL

PRogram In Support of Moms (PRISM)

Intervention Type: BEHAVIORAL

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

1. Engage clinic leaders and staff

2. Identify leadership group and prepare for change

3. Assess readiness to implement PRISM

4. Identify steps to achieve goals

5. Implement PRISM components into the clinic

6. Support, encourage and sustain change Office prompts Screening procedures Plus all MCPAP for Moms intervention

MCPAP for Moms

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.

Group Type: ACTIVE_COMPARATOR

MCPAP for Moms

Intervention Type: BEHAVIORAL

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

Interventions

PRogram In Support of Moms (PRISM)

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

1. Engage clinic leaders and staff

2. Identify leadership group and prepare for change

3. Assess readiness to implement PRISM

4. Identify steps to achieve goals

5. Implement PRISM components into the clinic

6. Support, encourage and sustain change Office prompts Screening procedures Plus all MCPAP for Moms intervention

Intervention Type: BEHAVIORAL

MCPAP for Moms

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Rapid Access to Perinatal Psychiatric care in Depression; RAPPID

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Nancy Byatt

Associate Professor of Psychiatry and Obstetrics & Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy Byatt, DO, MS, MBA

Role: PRINCIPAL_INVESTIGATOR

• UMass Memorial Medical Center/UMass Medical School

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Other Identifiers

UL1TR000161

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H00004195

Identifier Type: -

Identifier Source: org_study_id