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.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Health Services Research
- Masking: None (Open Label)
- Study Primary Completion Date: June 2020
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.
- Other: 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.
- Other: Collaborative Care
- Standard collaborative care implementation training and support.
Arms, Groups and Cohorts
- Experimental: 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.
- Active Comparator: Collaborative Care
- This comparator arm will consist of 10 cluster randomized health centers who receive training in collaborative care.
Clinical Trial Outcome Measures
- Clinical depression outcomes
- Time Frame: 12 months post-initiation of collaborative care
- Patient Health Questionnaire-9 (PHQ-9); level of depression symptomatology and functional impairment.
- Implementation outcomes
- Time Frame: 12 month post-implementation of collaborative care
- To 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.
Participating in This Clinical Trial
- 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.
- Age <18 or >45,
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.
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Washington
- Ochin, Inc.
- Provider of Information About this Clinical Study
- Principal Investigator: Ian Bennett, Professor – University of Washington
- Overall Official(s)
- Ian Bennett, Principal Investigator, University of Washington
- Overall Contact(s)
- Mindy Vredevoogd, MS, 206-543-4981, email@example.com
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