Remote Supervision for Implementing Collaborative Care for Perinatal Depression

NCT02976025 | Unknown DMC

• 2 other identifiers: STUDY000012941R01MH108548-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the impact of a longitudinal remote consultation (LRC) implementation strategy for collaborative care depression treatment among perinatal women. All participating health centers will receive training in collaborative care. Cluster randomization will be used to assign the addition of LRC to select health centers. Differences in implementation success, clinical outcomes, and costs will be compared after a 12 month implementation period and 13-21 month sustainment period.

Conditions

Perinatal Depression

Outcome Measures

Primary Outcomes (1)

• Clinical depression outcomes

  Patient Health Questionnaire-9 (PHQ-9); level of depression symptomatology and functional impairment.

  12 months post-initiation of collaborative care

Secondary Outcomes (1)

• Implementation outcomes

  12 month post-implementation of collaborative care

Other Outcomes (1)

• Cost and cost-effectiveness

  12-month post-implementation of collaborative care

Study Arms (2)

Longitudinal Remote Consultation

EXPERIMENTAL

This is the active treatment arm consisting of 10 cluster randomized health centers receiving both training in collaborative care and longitudinal remote consultation (LRC) support.

Other: Longitudinal Remote Consultation

Collaborative Care

ACTIVE COMPARATOR

This comparator arm will consist of 10 cluster randomized health centers who receive training in collaborative care.

Other: Collaborative Care

Interventions

Longitudinal Remote Consultation OTHER

Longitudinal Remote Consultation utilizes video conferencing to efficiently link providers to consultants who provide timely feedback and training in collaborative care. LRC will be provided in addition to standard collaborative care training and support.

Also known as: LRC

Longitudinal Remote Consultation

Collaborative Care OTHER

Standard collaborative care implementation training and support.

Also known as: CC

Collaborative Care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient participants must be perinatal women,
• Age 18-45,
• Receiving care at one of the 20 OCHIN or non-OCHIN health centers participating in the study and must have major depression as determined by a score of ≥10 on the PHQ-9 depression screener.

You may not qualify if:

• Age \<18 or \>45,
• Male.
• Health Center Participating Sites:
• Use of the shared OCHIN Epic electronic record for perinatal care or use of the secure AIMS CMTS/Caseload Tracker/spreadsheet patient registry for perinatal care and
• A minimum of 50 prenatal patients annually.

Sponsors & Collaborators

• University of Washington: lead
• OCHIN, Inc.: collaborator
• Oregon Social Learning Center: collaborator
• University of Pennsylvania: collaborator
• Washington University School of Medicine: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Grover T, Bennett IM, Campbell M, Vredevoogd M, Saldana L. Implementation cost analysis of collaborative care for perinatal mental health in community health centers. Res Sq [Preprint]. 2024 Nov 27:rs.3.rs-5256122. doi: 10.21203/rs.3.rs-5256122/v1.

  PMID: 39649162 DERIVED

Study Officials

• Ian Bennett

  University of Washington

  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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: November 29, 2016
• Study Start: April 1, 2017
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)