Clinical trial NCT02976025: Remote Supervision for Implementing Collaborative Care for Perinatal Depression
Official title: Remote Supervision for Implementing Collaborative Care for Perinatal Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perinatal Depression
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: OCHIN, Inc.
name: Oregon Social Learning Center
name: University of Pennsylvania
name: Washington University School of Medicine
name: National Institute of Mental Health (NIMH)
First posted: 2016-11-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: Clinical depression outcomes
timeFrame: 12 months post-initiation of collaborative care
Secondary outcomes:
measure: Implementation outcomes
timeFrame: 12 month post-implementation of collaborative care
Other outcomes:
measure: Cost and cost-effectiveness
timeFrame: 12-month post-implementation of collaborative care
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Ian Bennett
role: PRINCIPAL_INVESTIGATOR
References: