An interventional study of Longitudinal Remote Consultation and Collaborative Care in Perinatal Depression, sponsored by University of Washington. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by University of Washington · Not applicable, Interventional, and Health services research
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.
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.
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Patient Participants:
Inclusion Criteria:
Exclusion Criteria:
Health Center Participating Sites:
Inclusion Criteria:
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
This comparator arm will consist of 10 cluster randomized health centers who receive training in collaborative care.
Other: Collaborative Care
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
Standard collaborative care implementation training and support.
Also known as: CC
Clinical depression outcomes
Patient Health Questionnaire-9 (PHQ-9); level of depression symptomatology and functional impairment.
Time frame: 12 months post-initiation of collaborative care
Implementation outcomes
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.
Time frame: 12 month post-implementation of collaborative care
Cost and cost-effectiveness
For 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.
Time frame: 12-month post-implementation of collaborative care
Plan to share: Yes — We intend to share de-identified data once study is complete.
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This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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