Care Managers for Perinatal Depression (CMPD)

Sponsor
Lancaster General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01773629
Collaborator
University of Pennsylvania (Other), Robert Wood Johnson Foundation (Other)
194
4
2
39
48.5
1.2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Intervention
  • Other: Control
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
194 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Care Managers for Perinatal Depression (CMPD)
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Diagnosis of major depression within 2 weeks of screening [2 weeks after screening]

    Patient receipt of timely diagnosis for major depression during perinatal period.

  2. Treatment of major depression within 1 month of diagnosis [1 month]

    Patient receipt of timely initiation of treatment for major depression during the perinatal period.

  3. Transition of care from pregnancy to postpartum [4 months]

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

Secondary Outcome Measures

  1. Quantify the costs of implementing a care manager [3 years]

    Employ econometric techniques to quantify the costs of implementing and maintaining the care manager for managing perinatal depression.

  2. Qualitative assessment of success in implementation of perinatal depression care management process. [3 years]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Downtown Family Medicine Lancaster Pennsylvania United States 17604
2 Southeast Lancaster Health Services Lancaster Pennsylvania United States 17608
3 Broad Street Health Center Philadelphia Pennsylvania United States 19122
4 Haddington Health Center Philadelphia Pennsylvania United States 19139

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lancaster General Hospital
ClinicalTrials.gov Identifier:
NCT01773629
Other Study ID Numbers:
  • 2010-38-LGH
First Posted:
Jan 23, 2013
Last Update Posted:
Jan 30, 2014
Last Verified:
Jan 1, 2014
Keywords provided by Lancaster General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 30, 2014