NCT Number: NCT01810159
Integrated Collaborative Care for Substance Use Disorders
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Venice Family Clinic-Simms Mann Health Center, Santa Monica, California, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Education and Resources
OtherPrimary outcomes
-
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
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
RAND
Other
Registry information
Acronym: SUMMIT
Important dates
- Study start
- 2014
- Primary completion
- 2016
- Study completion
- 2017
- First posted
- Mar 13, 2013
- Registry last updated
- Apr 27, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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