Care Managers for Perinatal Depression (CMPD)

NCT01773629 | Completed

• 1 other identifier: 2010-38-LGH
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 4

Brief Summary

The investigators will evaluate effects of introducing the care manager on:

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

Conditions

Depression; Pregnancy

Keywords

Depression; Pregnancy; Postpartum; Perinatal

Outcome Measures

Primary Outcomes (3)

• Diagnosis of major depression within 2 weeks of screening

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

  2 weeks after screening

• 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

• 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

Secondary Outcomes (2)

• Quantify the costs of implementing a care manager

  3 years

• Qualitative assessment of success in implementation of perinatal depression care management process.

  3 years

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

OTHER

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

Interventions

Intervention OTHER

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

Control OTHER

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.

Control

Eligibility Criteria

• Age: 13 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Current pregnancy or experienced pregnancy in the past 6 weeks
• Score \>= 12 on PHQ9

You may not qualify if:

• \< age 13
• Mental illness
• Primary language other than English or Spanish

Sponsors & Collaborators

• Lancaster General Hospital: lead
• University of Pennsylvania: collaborator
• Robert Wood Johnson Foundation: collaborator

Study Sites (4)

Downtown Family Medicine

Lancaster, Pennsylvania, 17604, United States

Location

Southeast Lancaster Health Services

Lancaster, Pennsylvania, 17608, United States

Location

Broad Street Health Center

Philadelphia, Pennsylvania, 19122, United States

Location

Haddington Health Center

Philadelphia, Pennsylvania, 19139, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 23, 2013
• Study Start: September 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 30, 2014

Record last verified: 2014-01

Locations

US (4)