Clinical trial NCT01773629: Care Managers for Perinatal Depression (CMPD)
Official title: Care Managers for Perinatal Depression (CMPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Pregnancy
Keywords: Depression
Pregnancy
Postpartum
Perinatal
Lead sponsor: Lancaster General Hospital
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Robert Wood Johnson Foundation
First posted: 2013-01-23
Enrollment: 194
Sex: FEMALE
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Diagnosis of major depression within 2 weeks of screening
timeFrame: 2 weeks after screening
measure: Treatment of major depression within 1 month of diagnosis
timeFrame: 1 month
measure: Transition of care from pregnancy to postpartum
timeFrame: 4 months
Secondary outcomes:
measure: Quantify the costs of implementing a care manager
timeFrame: 3 years
measure: Qualitative assessment of success in implementation of perinatal depression care management process.
timeFrame: 3 years
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Downtown Family Medicine
state: Pennsylvania
city: Lancaster
country: United States
facility: Southeast Lancaster Health Services
state: Pennsylvania
city: Philadelphia
country: United States
facility: Broad Street Health Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Haddington Health Center
state: Pennsylvania
Study officials:
affiliation: Lancaster General Hospital
name: Stephen Ratcliffe, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Ian M Bennett, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Donna Cohen, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Michael A Horst, PhD, MPHS, MS
role: PRINCIPAL_INVESTIGATOR
References: