Integrated Collaborative Care for Substance Use Disorders (SUMMIT)

• ClinicalTrials.gov Identifier: NCT01810159
• Recruitment Status: Completed
• First Posted: March 13, 2013
• Last Update Posted: April 27, 2017
• Sponsor: RAND
• Information provided by (Responsible Party): RAND

Tracking Information

• First Submitted Date: March 11, 2013
• First Posted Date: March 13, 2013
• Last Update Posted Date: April 27, 2017
• Study Start Date: June 2014
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 25, 2017)

• unmet need [ Time Frame: past 6 months ]
  Of 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 days [ Time Frame: past 30 days ]
  change in abstinence from alcohol and opioid use between baseline and 6 month follow up
• negative consequences related to substance use [ Time Frame: past 3 months ]
  SIP-AD frequency questionnaire
• Functioning [ Time Frame: past 4 weeks ]
  change in SF-12 between baseline and follow up
• Engagement [ Time Frame: 30 days of initiation ]
  Proportion with at least 2 SUD-related visits within 30 days of initiation, Washington Circle
• initiation [ Time Frame: Within 14 days of index visit ]
  Washington Circle initiation indicator--at least one SUD-related visit within 14 days of index visit
• heavy alcohol use [ Time Frame: 6 months ]
  among people at baseline with heavy alcohol use, proportion with heavy alcohol use in past 30 days

Original Primary Outcome Measures (submitted: March 12, 2013)

• frequency of substance use [ Time Frame: past 30 days ]
  Past 30 days frequency of opiate or alcohol use
• Frequency of binge drinking [ Time Frame: past 30 days ]
  Frequency of drinking 5 or more drinks for men or 4 or more drinks for women in the past 30 days.
• negative consequences related to substance use [ Time Frame: past 3 months ]
  SIP-AD frequency questionnaire
• unmet need [ Time Frame: past 3 months ]
  Of those identified as screening positive for an opiate or alcohol use disorder, proportion who did not receive treatment for their substance use
• Functioning [ Time Frame: past 4 weeks ]
  change in SF-12 between baseline and follow up

Current Secondary Outcome Measures (submitted: April 25, 2017)

• Proportion initiating Brief therapy [ Time Frame: 6 months ]
  Proportion initiating brief therapy within 6 months
• Proportion initiating MAT [ Time Frame: 6 months ]
  Proportion 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 days [ Time Frame: collected at six months at the past 30 days ]
  abstinence from alcohol, opioids and all other drugs in the past 30 days

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Integrated Collaborative Care for Substance Use Disorders
• Official Title: Integrated Collaborative Care for Substance Use 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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

Primary Purpose: Health Services Research

• Condition: Substance Use Disorders

Intervention

• Other: Integrated collaborative care
• Other: Education and Resources

Study Arms

• Experimental: ICC
  Integrated collaborative care
  Intervention: Other: Integrated collaborative care
• Active Comparator: E&R
  Education and Resources--enhanced usual care
  Intervention: Other: Education and Resources

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 15, 2016): 397
• Original Estimated Enrollment (submitted: March 12, 2013): 400
• Actual Study Completion Date: January 2017
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01810159
• Other Study ID Numbers: R01DA034266( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: RAND
• Study Sponsor: RAND
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: RAND
• Verification Date: April 2017