Clinical trial NCT01810159: Integrated Collaborative Care for Substance Use Disorders
Official title: Integrated Collaborative Care for Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Keywords: substance use disorders
implementation science
collaborative care
opiate disorders
alcohol disorders
Lead sponsor: RAND
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* opiate or alcohol use disorder
* not currently in substance use disorder treatment
* past 30 day use of alcohol or opioids
* English or Spanish speaking

Exclusion Criteria:

* co-morbid severe mental illness
* medically unstable

Primary outcomes:
measure: unmet need
timeFrame: past 6 months
measure: abstinent from alcohol and opioid use, past 30 days
timeFrame: past 30 days
measure: negative consequences related to substance use
timeFrame: past 3 months
measure: Functioning
timeFrame: past 4 weeks
measure: Engagement
timeFrame: 30 days of initiation
measure: initiation
timeFrame: Within 14 days of index visit
measure: heavy alcohol use
timeFrame: 6 months
Secondary outcomes:
measure: Proportion initiating Brief therapy
timeFrame: 6 months
measure: Proportion initiating MAT
timeFrame: 6 months
measure: abstinence from alcohol, opioids and all other drugs in the previous 30 days
timeFrame: collected at six months at the past 30 days
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Venice Family Clinic-Simms Mann Health Center
state: California
city: Venice
country: United States
facility: Venice Family Clinic-Rose lAvenue
state: California
Study officials:
References:
citation: Hunter SB, Ober AJ, McCullough CM, Storholm ED, Iyiewuare PO, Pham C, Watkins KE. Sustaining alcohol and opioid use disorder treatment in primary care: a mixed methods study. Implement Sci. 2018 Jun 18;13(1):83. doi: 10.1186/s13012-018-0777-y.
citation: Watkins KE, Ober AJ, Lamp K, Lind M, Setodji C, Osilla KC, Hunter SB, McCullough CM, Becker K, Iyiewuare PO, Diamant A, Heinzerling K, Pincus HA. Collaborative Care for Opioid and Alcohol Use Disorders in Primary Care: The SUMMIT Randomized Clinical Trial. JAMA Intern Med. 2017 Oct 1;177(10):1480-1488. doi: 10.1001/jamainternmed.2017.3947.
citation: Ober AJ, Watkins KE, Hunter SB, Lamp K, Lind M, Setodji CM. An organizational readiness intervention and randomized controlled trial to test strategies for implementing substance use disorder treatment into primary care: SUMMIT study protocol. Implement Sci. 2015 May 8;10:66. doi: 10.1186/s13012-015-0256-7.