Integrated Collaborative Care for Substance Use Disorders (SUMMIT)

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.

Study Overview

• Status: Completed
• Conditions: Substance Use Disorders
• Intervention / Treatment: Other: Integrated collaborative care; Other: Education and Resources

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.

• Study Type: Interventional
• Enrollment (Actual): 397
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90405
      • Venice Family Clinic-Simms Mann Health Center
    • Venice, California, United States, 90291
      • Venice Family Clinic-Rose lAvenue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICC; Integrated collaborative care	Other: Integrated collaborative care
Active Comparator: E&R; Education and Resources--enhanced usual care	Other: Education and Resources

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
unmet need	Of those identified as screening positive for an opiate or alcohol use disorder, proportion who did not receive treatment for their substance use	past 6 months
abstinent from alcohol and opioid use, past 30 days	change in abstinence from alcohol and opioid use between baseline and 6 month follow up	past 30 days
negative consequences related to substance use	SIP-AD frequency questionnaire	past 3 months
Functioning	change in SF-12 between baseline and follow up	past 4 weeks
Engagement	Proportion with at least 2 SUD-related visits within 30 days of initiation, Washington Circle	30 days of initiation
initiation	Washington Circle initiation indicator--at least one SUD-related visit within 14 days of index visit	Within 14 days of index visit
heavy alcohol use	among people at baseline with heavy alcohol use, proportion with heavy alcohol use in past 30 days	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion initiating Brief therapy	Proportion initiating brief therapy within 6 months	6 months
Proportion initiating MAT	Proportion initiating MAT within 6 months, among those eligible for MAT, and if N's are large enough, stratified by type of MAT	6 months
abstinence from alcohol, opioids and all other drugs in the previous 30 days	abstinence from alcohol, opioids and all other drugs in the past 30 days	collected at six months at the past 30 days

Collaborators and Investigators

• Sponsor: RAND

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: March 11, 2013
• First Submitted That Met QC Criteria: March 12, 2013
• First Posted (Estimate): March 13, 2013

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: implementation science; substance use disorders; collaborative care; opiate disorders; alcohol disorders
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Disease
• Other Study ID Numbers: R01DA034266 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No