Integrated Collaborative Care for Substance Use Disorders

Substance Use Disorders Clinical Trial

— SUMMIT  

Official title:

Integrated Collaborative Care for Substance Use Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810159
• Other study ID #: R01DA034266
• Status: Completed
• Phase: N/A
• First received: March 11, 2013
• Last updated: April 25, 2017
• Start date: June 2014
• Est. completion date: January 2017

Study information

• Verified date: April 2017
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: January 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Other:
• Integrated collaborative care

• Education and Resources

Locations

Country	Name	City	State
United States	Venice Family Clinic-Simms Mann Health Center	Santa Monica	California
United States	Venice Family Clinic-Rose lAvenue	Venice	California

Sponsors (1)

Lead Sponsor	Collaborator
RAND

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	negative consequences related to substance use	SIP-AD frequency questionnaire	past 3 months
Primary	Functioning	change in SF-12 between baseline and follow up	past 4 weeks
Primary	Engagement	Proportion with at least 2 SUD-related visits within 30 days of initiation, Washington Circle	30 days of initiation
Primary	initiation	Washington Circle initiation indicator--at least one SUD-related visit within 14 days of index visit	Within 14 days of index visit
Primary	heavy alcohol use	among people at baseline with heavy alcohol use, proportion with heavy alcohol use in past 30 days	6 months
Secondary	Proportion initiating Brief therapy	Proportion initiating brief therapy within 6 months	6 months
Secondary	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
Secondary	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