NCT01810159

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
397

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

2.3 years

First QC Date

March 11, 2013

Last Update Submit

April 25, 2017

Conditions

Keywords

substance use disordersimplementation sciencecollaborative careopiate disordersalcohol disorders

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • negative consequences related to substance use

    SIP-AD frequency questionnaire

    past 3 months

  • Functioning

    change in SF-12 between baseline and follow up

    past 4 weeks

  • Engagement

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

    30 days of initiation

  • initiation

    Washington Circle initiation indicator--at least one SUD-related visit within 14 days of index 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

    6 months

Secondary Outcomes (3)

  • Proportion initiating Brief therapy

    6 months

  • Proportion initiating MAT

    6 months

  • abstinence from alcohol, opioids and all other drugs in the previous 30 days

    collected at six months at the past 30 days

Study Arms (2)

ICC

EXPERIMENTAL

Integrated collaborative care

Other: Integrated collaborative care

E&R

ACTIVE COMPARATOR

Education and Resources--enhanced usual care

Other: Education and Resources

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • opiate or alcohol use disorder
  • not currently in substance use disorder treatment
  • past 30 day use of alcohol or opioids
  • English or Spanish speaking

You may not qualify if:

  • co-morbid severe mental illness
  • medically unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Venice Family Clinic-Simms Mann Health Center

Santa Monica, California, 90405, United States

Location

Venice Family Clinic-Rose lAvenue

Venice, California, 90291, United States

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Substance-Related DisordersAlcohol-Related Disorders

Interventions

Educational StatusHealth Resources

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsHealth PlanningHealth Care Economics and OrganizationsDelivery of Health CareHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 13, 2013

Study Start

June 1, 2014

Primary Completion

September 1, 2016

Study Completion

January 1, 2017

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations