Substance Use Disorders Clinical Trial
Official title:
Integrated Collaborative Care for Substance Use Disorders
Primary care settings (PCS) are a missed opportunity for delivering evidence-based
treatments for opiate and alcohol-use disorders (OAUD). The investigators propose to
evaluate the costs and effectiveness of two strategies to increase the delivery of OAUD
treatments in PCS, integrated collaborative care (ICC) and education and resources (E&R).
The investigators hypothesize that ICC will be more effective than E&R in promoting A.
Implementation outcomes B. Service system outcomes and C. Patient outcomes.
Results from our study will help providers choose between two different strategies and
advance the field of implementation research.
Most individuals with opiate and alcohol-use disorders (OAUD) do not receive treatment.
Primary care is an ideal setting in which to deliver OAUD treatment, yet evidence-based OAUD
treatment is rarely provided.
Barriers to delivery include insufficient organizational support and lack of provider role
models and clinical support. The investigators propose to evaluate the effectiveness of two
strategies for increasing use of evidence-based treatment for OAUD within primary care:
integrated collaborative care (ICC) and education and resources (E&R). While both strategies
provide primary care practices with the same clinical information, ICC addresses these
barriers by including organizational and technical support for delivering evidence-based
care. ICC is grounded in the chronic care model and includes a behavioral health provider
working as part of the care team.
Essential elements of ICC strategy include a decision support component to help providers
with complex patients, and a restructuring of the delivery and clinical information systems
to support the delivery of evidence-based care. Our approach to implementing ICC is based on
the organizational transformation model and quality improvement. The investigators define
the E&R strategy as providing printed educational materials and access to resources along
with provider education. Both strategies are designed to increase the delivery of two
evidence-based practices: motivational enhancement therapy and medication assisted therapy.
The investigators propose a 5-year mixed methods study and will conduct a RCT, with
randomization occurring at the level of the care team and patient. The investigators partner
with 5 Venice Family Clinic (VFC) clinics, two hospitals in LA County, and COPE Health
Solutions. VFC is a large federally qualified health center (FQHC) and the largest free
clinic in the United States. Our approach includes document review, focus groups,
interviews, and surveys for obtaining data on the adoption process and implementation
outcomes; analysis of patient records and patient surveys on service system and patient
outcomes; and analysis of provider financial records and patient records and surveys for
estimating costs. The investigators will enroll 400 patients with an OAUD diagnosis and
follow them at 3 and 12 months. Our specific aims are: 1) To measure the process and extent
of ICC and E&R implementation; 2) To test the effectiveness of ICC compared to an E&R
strategy in promoting A. Implementation outcomes B. Service system outcomes and C. Patient
outcomes; and 3) To estimate provider costs for each strategy. The investigators define
implementation outcomes as measures of the acceptability, adoption, appropriateness,
feasibility, and sustainability of evidence-based OAUD treatment. The investigators define
service system outcomes as 1) process measures of treatment quality and 2) treatment
co-morbidities. The investigators define patient outcomes as hospital readmissions, OAUD
outcomes, patient functioning, negative consequences from substance use, and unmet need. The
investigators define cost outcomes as start-up costs, operating costs and
medical/psychiatric cost offsets.
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