Skip to main content
OpenTrials
Completed

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.

Completed

Looking for future studies?

Notify Me

Key information

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

Loading trial locations.

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

Integrated collaborative care

Other

Education and Resources

Other

Primary outcomes

  1. 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

  2. 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

  3. negative consequences related to substance use

    Time frame: past 3 months

    SIP-AD frequency questionnaire

  4. Functioning

    Time frame: past 4 weeks

    change in SF-12 between baseline and follow up

  5. Engagement

    Time frame: 30 days of initiation

    Proportion with at least 2 SUD-related visits within 30 days of initiation, Washington Circle

  6. 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

  7. 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

  1. Proportion initiating Brief therapy

    Time frame: 6 months

    Proportion initiating brief therapy within 6 months

  2. 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

  3. 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.

Published trials that share one or more normalized conditions with this study.