Remote Supervision for Implementing Collaborative Care for Perinatal Depression

NCT ID: NCT02976025

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2021-07-31

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.

Detailed Description

Depression is a common and serious disorder among pregnant women but few from low income groups receive effective treatment. The highly evidence based collaborative care (CC) model for depression has been shown to work for women in pregnancy but has not been widely implemented in this population. The proposed study targets improving dissemination of the evidence based CC treatment model for pregnant and postpartum women with depression, a common disorder of the perinatal period (pregnancy and the first year following birth). Longitudinal remote consultation (LRC) is an implementation strategy that has been have shown to improve fidelity to evidence-based practices and patient outcomes for mental health innovations. The investigators believe LRC can be used with equal benefit for complex interventions such as CC.

The purpose of this study is to compare two implementation strategies for Collaborative Care depression treatment: 1) standard implementation and 2) standard implementation + Longitudinal Remote Consultation (LRC). This research is being done in order to assess implementation and patient outcomes in sites receiving a standard implementation approach with and without LRC. The results of the proposed study will provide information on the benefits and relative value of ongoing consultation, such as LRC, for implementation of complex interventions like collaborative care.

The proposed study will involve twenty health centers providing prenatal care which are part of the national OCHIN Network or other health center network. All sites will receive a standard implementation approach. After pre-implementation training ten of the sites will be randomly selected to receive LRC. Implementation and clinical outcomes as well as costs will be compared between the study conditions after a 12 month implementation period and a 13-21 month sustainment period. The results of the proposed study will provide critical generalizable knowledge regarding the benefits of ongoing consultation for implementation of complex interventions like collaborative care.

Conditions

Perinatal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Longitudinal Remote Consultation

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.

Group Type: EXPERIMENTAL

Longitudinal Remote Consultation

Intervention Type: 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.

Collaborative Care

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

Group Type: ACTIVE_COMPARATOR

Collaborative Care

Intervention Type: OTHER

Standard collaborative care implementation training and support.

Interventions

Longitudinal Remote Consultation

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.

Intervention Type: OTHER

Collaborative Care

Standard collaborative care implementation training and support.

Intervention Type: OTHER

Other Intervention Names

LRC; CC

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

Exclusion Criteria

• Age <18 or >45,
• Male.

Health Center Participating Sites:

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

OCHIN, Inc.

OTHER

Sponsor Role: collaborator

Oregon Social Learning Center

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Ian Bennett

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ian Bennett

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39649162 (View on PubMed)

Other Identifiers

1R01MH108548-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001294

Identifier Type: -

Identifier Source: org_study_id