Care Managers for Perinatal Depression (CMPD)

NCT ID: NCT01773629

Last Updated: 2014-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-12-31

Brief Summary

The investigators will evaluate effects of introducing the care manager on:

1. Patient receipt of timely diagnosis and initiation of treatment for major depression (diagnosis within 2 weeks of screening and treatment within 1 month of diagnosis); and

2. Patient continuity of care for depression across the transition of care from pregnancy to postpartum (within 4 months postpartum).

Detailed Description

The first two specific research aims of this proposed randomized study will evaluate the benefits of introducing site specific care managers into established multi-component enhancements of perinatal depression care. The four study sites are members of the IMPLICIT perinatal quality improvement network and provide prenatal care to a diverse population of low income minority women using a common set of care processes within diverse practice models including Obstetric, Family Medicine, and Nurse Practitioner/Midwifery settings. The established processes of care include evidence based screening, diagnosis, treatment protocols and quality improvement care teams.

The investigators will evaluate effects of introducing the care manager on:

1. Patient receipt of timely diagnosis and initiation of treatment for major depression (diagnosis within 2 weeks of screening and treatment within 1 month of diagnosis); and

2. Patient continuity of care for depression across the transition of care from pregnancy to postpartum (within 4 months postpartum).

For the third and fourth specific research aims we will conduct supplementary econometric and qualitative analyses to aid in understanding the provider and system context in which this intervention is implemented across the four study sites. Results of this evaluation will be used to understand for whom and in which systems of care this model is most successful as well as the costs of delivering this intervention.

Specifically the investigators will:

1. Employ econometric techniques to quantify the costs of implementing and maintaining the IMPLICIT collaborative care maternal depression intervention; and

2. Develop institutional ethnographies of the four study sites and identify factors associated with relative success in implementing perinatal depression care managers and improving timely diagnosis, initiation, and continuity of depression care.

Achieving these aims will provide the foundation for dissemination of this innovative approach to perinatal depression care delivery throughout the entire growing IMPLICIT network which now extends across the northeast and mid-Atlantic regions of the US; sites which provide perinatal care for low income minority women in urban, rural, and suburban communities. These sites include prenatal practices in the Robert Wood Johnson Foundation Aligning Forces for Quality initiative, the Healthy York County Coalition which is partnering with us to disseminate this work in their region.

Conditions

Depression; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

Participants in the intervention arm will receive standard care plus the addition of a care manager. Care managers will function to provide culturally competent and linguistically appropriate support for the care of women identified as being at high risk for depression in pregnancy. Working with both the care providers and these study participants care managers will serve as connectors, coaches, collaborators, and negotiators working to overcome barriers to depression care delivery.

Group Type: EXPERIMENTAL

Intervention

Intervention Type: OTHER

Participants in the intervention arm will receive standard care plus the addition of a care manager. Care managers will function to provide culturally competent and linguistically appropriate support for the care of women identified as being at high risk for depression in pregnancy. Working with both the care providers and these study participants care managers will serve as connectors, coaches, collaborators, and negotiators working to overcome barriers to depression care delivery.

Control

Standard of care: within the current care processes, a woman initiating prenatal care completes a depression risk assessment using a two-step approach. Women with high risk of depression are then scheduled for a separate visit with a member of the care team (a physician, psychologist, or other mental health provider) referred to as a "perinatal depression champion" for a timely formal diagnostic interview.

Group Type: OTHER

Control

Intervention Type: OTHER

Standard of care: within the current care processes, a woman initiating prenatal care completes a depression risk assessment using a two-step approach. Women with high risk of depression are then scheduled for a separate visit with a member of the care team (a physician, psychologist, or other mental health provider) referred to as a "perinatal depression champion" for a timely formal diagnostic interview.

Interventions

Intervention

Participants in the intervention arm will receive standard care plus the addition of a care manager. Care managers will function to provide culturally competent and linguistically appropriate support for the care of women identified as being at high risk for depression in pregnancy. Working with both the care providers and these study participants care managers will serve as connectors, coaches, collaborators, and negotiators working to overcome barriers to depression care delivery.

Intervention Type: OTHER

Control

Standard of care: within the current care processes, a woman initiating prenatal care completes a depression risk assessment using a two-step approach. Women with high risk of depression are then scheduled for a separate visit with a member of the care team (a physician, psychologist, or other mental health provider) referred to as a "perinatal depression champion" for a timely formal diagnostic interview.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Female
• Current pregnancy or experienced pregnancy in the past 6 weeks
• Score >= 12 on PHQ9

Exclusion Criteria

• < age 13
• Mental illness
• Primary language other than English or Spanish

• Minimum Eligible Age: 13 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Robert Wood Johnson Foundation

OTHER

Sponsor Role: collaborator

Lancaster General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Ratcliffe, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Ian M Bennett, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Donna Cohen, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Michael A Horst, PhD, MPHS, MS

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Locations

Downtown Family Medicine

Lancaster, Pennsylvania, United States

Southeast Lancaster Health Services

Lancaster, Pennsylvania, United States

Broad Street Health Center

Philadelphia, Pennsylvania, United States

Haddington Health Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

2010-38-LGH

Identifier Type: -

Identifier Source: org_study_id