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Integrated Collaborative Care for Substance Use Disorders

Integrated Collaborative Care for Substance Use Disorders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01810159
Acronym
SUMMIT
Enrollment
397
Registered
2013-03-13
Start date
2014-06-30
Completion date
2017-01-31
Last updated
2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use Disorders

Keywords

substance use disorders, implementation science, collaborative care, opiate disorders, alcohol disorders

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.

Interventions

OTHERIntegrated collaborative care
OTHEREducation and Resources

Sponsors

RAND
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

We used an R software random number generator to randomly assign eligible participants to either CC or usual care. We used a concealed randomization protocol where neither participant nor researcher (outside of the statistician doing the randomization) was aware of the randomization until after the baseline interview. None of the participants or providers was blinded to treatment allocation after randomization. Interviewers were blinded to treatment allocation

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
heavy alcohol use6 monthsamong people at baseline with heavy alcohol use, proportion with heavy alcohol use in past 30 days
Functioningpast 4 weekschange in SF-12 between baseline and follow up
Engagement30 days of initiationProportion with at least 2 SUD-related visits within 30 days of initiation, Washington Circle
initiationWithin 14 days of index visitWashington Circle initiation indicator--at least one SUD-related visit within 14 days of index visit
unmet needpast 6 monthsOf those identified as screening positive for an opiate or alcohol use disorder, proportion who did not receive treatment for their substance use
abstinent from alcohol and opioid use, past 30 dayspast 30 dayschange in abstinence from alcohol and opioid use between baseline and 6 month follow up
negative consequences related to substance usepast 3 monthsSIP-AD frequency questionnaire

Secondary

MeasureTime frameDescription
Proportion initiating MAT6 monthsProportion initiating MAT within 6 months, among those eligible for MAT, and if N's are large enough, stratified by type of MAT
abstinence from alcohol, opioids and all other drugs in the previous 30 dayscollected at six months at the past 30 daysabstinence from alcohol, opioids and all other drugs in the past 30 days
Proportion initiating Brief therapy6 monthsProportion initiating brief therapy within 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026