Care Managers for Perinatal Depression (CMPD)

Depression Clinical Trial

— CMPD  

Official title:

Care Managers for Perinatal Depression (CMPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773629
• Other study ID #: 2010-38-LGH
• Status: Completed
• Phase: N/A
• First received: January 16, 2013
• Last updated: January 29, 2014
• Start date: September 2010
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Lancaster General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asphyxia Neonatorum
• Depression
• Depressive Disorder
• Pregnancy

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (3)

Lead Sponsor	Collaborator
Lancaster General Hospital	Robert Wood Johnson Foundation, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of major depression within 2 weeks of screening	Patient receipt of timely diagnosis for major depression during perinatal period.	2 weeks after screening	No
Primary	Treatment of major depression within 1 month of diagnosis	Patient receipt of timely initiation of treatment for major depression during the perinatal period.	1 month	No
Primary	Transition of care from pregnancy to postpartum	Patient continuity of care for depression across the transition of care from pregnancy to postpartum within 4 months postpartum.	4 months	No
Secondary	Quantify the costs of implementing a care manager	Employ econometric techniques to quantify the costs of implementing and maintaining the care manager for managing perinatal depression.	3 years	No
Secondary	Qualitative assessment of success in implementation of perinatal depression care management process.	Develop institutional ethnographies of the 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. Qualitative measures include efficacy of core implementation group, commitment of implementation group, commitment of user group and readiness to change.	3 years	No