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Care Managers for Perinatal Depression (CMPD) (CMPD)

Primary Purpose

Depression, Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Control
Sponsored by
Lancaster General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring Depression, Pregnancy, Postpartum, Perinatal

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Downtown Family Medicine
  • Southeast Lancaster Health Services
  • Broad Street Health Center
  • Haddington Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Diagnosis of major depression within 2 weeks of screening
Patient receipt of timely diagnosis for major depression during perinatal period.
Treatment of major depression within 1 month of diagnosis
Patient receipt of timely initiation of treatment for major depression during the perinatal period.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 16, 2013
Last Updated
January 29, 2014
Sponsor
Lancaster General Hospital
Collaborators
University of Pennsylvania, Robert Wood Johnson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01773629
Brief Title
Care Managers for Perinatal Depression (CMPD)
Acronym
CMPD
Official Title
Care Managers for Perinatal Depression (CMPD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lancaster General Hospital
Collaborators
University of Pennsylvania, Robert Wood Johnson Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators will evaluate effects of introducing the care manager on: 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 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: 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 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: Employ econometric techniques to quantify the costs of implementing and maintaining the IMPLICIT collaborative care maternal depression intervention; and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Pregnancy
Keywords
Depression, Pregnancy, Postpartum, Perinatal

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
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
Intervention Name(s)
Intervention
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnosis of major depression within 2 weeks of screening
Description
Patient receipt of timely diagnosis for major depression during perinatal period.
Time Frame
2 weeks after screening
Title
Treatment of major depression within 1 month of diagnosis
Description
Patient receipt of timely initiation of treatment for major depression during the perinatal period.
Time Frame
1 month
Title
Transition of care from pregnancy to postpartum
Description
Patient continuity of care for depression across the transition of care from pregnancy to postpartum within 4 months postpartum.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Quantify the costs of implementing a care manager
Description
Employ econometric techniques to quantify the costs of implementing and maintaining the care manager for managing perinatal depression.
Time Frame
3 years
Title
Qualitative assessment of success in implementation of perinatal depression care management process.
Description
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.
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Ratcliffe, MD, MSPH
Organizational Affiliation
Lancaster General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ian M Bennett, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Donna Cohen, MD, MS
Organizational Affiliation
Lancaster General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael A Horst, PhD, MPHS, MS
Organizational Affiliation
Lancaster General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Downtown Family Medicine
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Southeast Lancaster Health Services
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17608
Country
United States
Facility Name
Broad Street Health Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States
Facility Name
Haddington Health Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States

12. IPD Sharing Statement

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Care Managers for Perinatal Depression (CMPD)

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