Care Managers for Perinatal Depression (CMPD)

This study has been completed.
Sponsor:
Collaborators:
University of Pennsylvania
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Lancaster General Hospital
ClinicalTrials.gov Identifier:
NCT01773629
First received: January 16, 2013
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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).

Condition Intervention
Depression
Pregnancy
Other: Intervention
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Care Managers for Perinatal Depression (CMPD)

Resource links provided by NLM:


Further study details as provided by Lancaster General Hospital:

Primary Outcome Measures:
  • Diagnosis of major depression within 2 weeks of screening [ Time Frame: 2 weeks after screening ] [ Designated as safety issue: No ]
    Patient receipt of timely diagnosis for major depression during perinatal period.

  • Treatment of major depression within 1 month of diagnosis [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Patient receipt of timely initiation of treatment for major depression during the perinatal period.

  • Transition of care from pregnancy to postpartum [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Patient continuity of care for depression across the transition of care from pregnancy to postpartum within 4 months postpartum.


Secondary Outcome Measures:
  • Quantify the costs of implementing a care manager [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Employ econometric techniques to quantify the costs of implementing and maintaining the care manager for managing perinatal depression.

  • Qualitative assessment of success in implementation of perinatal depression care management process. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 194
Study Start Date: September 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773629

Locations
United States, Pennsylvania
Downtown Family Medicine
Lancaster, Pennsylvania, United States, 17604
Southeast Lancaster Health Services
Lancaster, Pennsylvania, United States, 17608
Haddington Health Center
Philadelphia, Pennsylvania, United States, 19139
Broad Street Health Center
Philadelphia, Pennsylvania, United States, 19122
Sponsors and Collaborators
Lancaster General Hospital
University of Pennsylvania
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Stephen Ratcliffe, MD, MSPH Lancaster General Hospital
Principal Investigator: Ian M Bennett, MD, PhD University of Pennsylvania
Principal Investigator: Donna Cohen, MD, MS Lancaster General Hospital
Principal Investigator: Michael A Horst, PhD, MPHS, MS Lancaster General Hospital
  More Information

No publications provided

Responsible Party: Lancaster General Hospital
ClinicalTrials.gov Identifier: NCT01773629     History of Changes
Other Study ID Numbers: 2010-38-LGH
Study First Received: January 16, 2013
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Lancaster General Hospital:
Depression
Pregnancy
Postpartum
Perinatal

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014