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Remote Supervision for Implementing Collaborative Care for Perinatal Depression

Remote Supervision for Implementing Collaborative Care for Perinatal Depression

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02976025
Acronym
MInD-I
Enrollment
20
Registered
2016-11-29
Start date
2017-04-01
Completion date
2021-07-31
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal Depression

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.

Interventions

OTHERLongitudinal 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.

OTHERCollaborative Care

Standard collaborative care implementation training and support.

Sponsors

OCHIN, Inc.
CollaboratorOTHER
Oregon Social Learning Center
CollaboratorOTHER
University of Pennsylvania
CollaboratorOTHER
Washington University School of Medicine
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

Patient Participants: 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.

Exclusion criteria

* Age \<18 or \>45, * Male. Health Center Participating Sites: Inclusion Criteria: * 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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical depression outcomes12 months post-initiation of collaborative carePatient Health Questionnaire-9 (PHQ-9); level of depression symptomatology and functional impairment.

Secondary

MeasureTime frameDescription
Implementation outcomes12 month post-implementation of collaborative careTo assess the degree to which sites in the two conditions complete implementation, the investigators will use the Stages of Implementation Completion tool tailored for collaborative care, SIC-CC.

Other

MeasureTime frameDescription
Cost and cost-effectiveness12-month post-implementation of collaborative careFor a cost-benefit analysis, the investigators will use of the Cost of Implementing New Strategies (COINS) method to assess costs in the two conditions. This methodology takes advantage of the SIC-CC instrument as a costing template to map the use of resources and associated costs to these to study conditions. Costs associated with implementation in each of these conditions will be carried out for all 20 health centers included in the study.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026