Integrated Collaborative Care for Substance Use Disorders (SUMMIT)
Primary Purpose
Substance Use Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated collaborative care
Education and Resources
Sponsored by
About this trial
This is an interventional health services research trial for Substance Use Disorders focused on measuring substance use disorders, implementation science, collaborative care, opiate disorders, alcohol disorders
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
Sites / Locations
- Venice Family Clinic-Simms Mann Health Center
- Venice Family Clinic-Rose lAvenue
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ICC
E&R
Arm Description
Integrated collaborative care
Education and Resources--enhanced usual care
Outcomes
Primary Outcome Measures
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
abstinent from alcohol and opioid use, past 30 days
change in abstinence from alcohol and opioid use between baseline and 6 month follow up
negative consequences related to substance use
SIP-AD frequency questionnaire
Functioning
change in SF-12 between baseline and follow up
Engagement
Proportion with at least 2 SUD-related visits within 30 days of initiation, Washington Circle
initiation
Washington Circle initiation indicator--at least one SUD-related 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
Secondary Outcome Measures
Proportion initiating Brief therapy
Proportion initiating brief therapy within 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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01810159
Brief Title
Integrated Collaborative Care for Substance Use Disorders
Acronym
SUMMIT
Official Title
Integrated Collaborative Care for Substance Use Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
substance use disorders, implementation science, collaborative care, opiate disorders, alcohol disorders
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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
Allocation
Randomized
Enrollment
397 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICC
Arm Type
Experimental
Arm Description
Integrated collaborative care
Arm Title
E&R
Arm Type
Active Comparator
Arm Description
Education and Resources--enhanced usual care
Intervention Type
Other
Intervention Name(s)
Integrated collaborative care
Intervention Type
Other
Intervention Name(s)
Education and Resources
Primary Outcome Measure Information:
Title
unmet need
Description
Of those identified as screening positive for an opiate or alcohol use disorder, proportion who did not receive treatment for their substance use
Time Frame
past 6 months
Title
abstinent from alcohol and opioid use, past 30 days
Description
change in abstinence from alcohol and opioid use between baseline and 6 month follow up
Time Frame
past 30 days
Title
negative consequences related to substance use
Description
SIP-AD frequency questionnaire
Time Frame
past 3 months
Title
Functioning
Description
change in SF-12 between baseline and follow up
Time Frame
past 4 weeks
Title
Engagement
Description
Proportion with at least 2 SUD-related visits within 30 days of initiation, Washington Circle
Time Frame
30 days of initiation
Title
initiation
Description
Washington Circle initiation indicator--at least one SUD-related visit within 14 days of index visit
Time Frame
Within 14 days of index visit
Title
heavy alcohol use
Description
among people at baseline with heavy alcohol use, proportion with heavy alcohol use in past 30 days
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion initiating Brief therapy
Description
Proportion initiating brief therapy within 6 months
Time Frame
6 months
Title
Proportion initiating MAT
Description
Proportion initiating MAT within 6 months, among those eligible for MAT, and if N's are large enough, stratified by type of MAT
Time Frame
6 months
Title
abstinence from alcohol, opioids and all other drugs in the previous 30 days
Description
abstinence from alcohol, opioids and all other drugs in the past 30 days
Time Frame
collected at six months at the past 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Venice Family Clinic-Simms Mann Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90405
Country
United States
Facility Name
Venice Family Clinic-Rose lAvenue
City
Venice
State/Province
California
ZIP/Postal Code
90291
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29914524
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.
Results Reference
derived
PubMed Identifier
28846769
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.
Results Reference
derived
PubMed Identifier
25951953
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.
Results Reference
derived
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Integrated Collaborative Care for Substance Use Disorders
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