This trial is active, not recruiting.

Condition substance related disorders
Treatments primary care physician, behavioral medicine specialist
Sponsor University of California, San Francisco
Collaborator Kaiser Permanente
Start date October 2011
End date October 2013
Trial size 9084 participants
Trial identifier NCT02408952, 11-07796


This study evaluates the implementation and effectiveness of two modalities of Screening, Brief Intervention and Referral to Treatment (SBIRT) to reduce adolescent alcohol and other drug (AOD) use in a large pediatrics clinic.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose screening
If the adolescent is identified at risk for substance use, the screening and brief intervention referral to treatment delivered is by the primary care physician
primary care physician
The screening, brief intervention and referral to treatment is delivered by the Primary Care Physician
If the adolescent is identified at risk for substance use, the screening and brief intervention referral to treatment delivered by the behavioral medicine specialist
behavioral medicine specialist
The screening, brief intervention and referral to treatment is delivered by the Behavioral Medicine Specialist.
(No Intervention)
Care is administered as usual

Primary Outcomes

Screening rate
time frame: Initial screening rate - at index well-visit
Problem Identification rate
time frame: Initital problem identification rate - at index well-visit, following screening
Assessment rate
time frame: Within 2 weeks following index well-visit date
Brief Intervention rate
time frame: Within 14 days of assessment at index well visit
Referral to specialty treatment rate
time frame: Within 6 months of index well-visit

Secondary Outcomes

Specialty Behavioral Health Treatment Initiation
time frame: Within 2 years post-intervention
Alcohol and other drug use
time frame: Use in past 6 months, at 1 and 2 years post-intervention
Substance Use-related outcomes
time frame: in past 6 months, at 1 and 2 years post-intervention

Eligibility Criteria

Male or female participants from 12 years up to 80 years old.

There are two study populations as described below thus the large age limit range. Inclusion Criteria: - All adolescent primary care providers at the pediatric primary care clinic will be included. - All adolescent patient electronic records, ages 12-18, at the pediatric primary care will be examined. Exclusion Criteria: - Any adolescent primary care providers not practicing at the pediatric primary care clinic research site will be excluded. - Adolescents electronic records who are not part of the research site pediatric clinic will be excluded.

Additional Information

Official title Screening for Youth Alcohol and Drug Use: A Study of Primary Care Providers
Description Health systems have not implemented Screening, Brief Intervention and Referral to Treatment (SBIRT) for adolescents despite research demonstrating its effectiveness. Based on prior research that identified barriers to AOD screening for adolescents in pediatric Primary Care (PC) and a pilot study that found SBIRT was feasible, well-received and promoted referrals to and initiation of specialty treatment, the current research application proposes to randomize 45 Primary Care Physicians (PCPs) in the pediatrics clinic of a medical center within a large, managed care health system, Kaiser Permanente Northern California, to three arms - 1) Usual Care; 2) SBIRT delivered by PCPs; and 3) SBIRT delivered by Behavioral Medicine Specialists (BMS). The study objective is to compare the implementation, effectiveness and cost-effectiveness of SBIRT for adolescents in PC in the three study arms. Patients will complete evidence-based screening and AOD assessment measures which have been embedded in the health plan's electronic medical record (EMR). A mixed model will be used to compare implementation outcomes (rates of screening and identification, brief intervention, referral to Chemical Dependency treatment and treatment initiation), and effectiveness (patient outcomes of AOD use and abstinence) at 12 months. The model accounts for the intra-class correlations across patients within providers. Cost-effectiveness relative to implementation and patient outcomes will be examined. Barriers and facilitators of implementation, and feasibility via qualitative interviews with clinicians and administrators will be examined as well. The study is significant in that it examines issues that must be addressed to spur widespread adaptation of SBIRT. The proposed interventions are highly feasible in the current environment of health reform due to increased resources and training to Federally Qualified Health Centers and private health plans. It is innovative in using the EMR to change clinical practice and systematically integrate AOD in PC, and as a platform for collecting research data.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by University of California, San Francisco.