Clinical trial NCT02408952: Screening for Youth Alcohol and Drug Use: A Study of Primary Care Providers
Official title: Screening for Youth Alcohol and Drug Use: A Study of Primary Care Providers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance Related Disorders
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2015-04-06
Enrollment: 9084
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Screening rate
timeFrame: Initial screening rate - at index well-visit
measure: Problem Identification rate
timeFrame: Initital problem identification rate - at index well-visit, following screening
measure: Assessment rate
timeFrame: Within 2 weeks following index well-visit date
measure: Brief Intervention rate
timeFrame: Within 14 days of assessment at index well visit
measure: Referral to specialty treatment rate
timeFrame: Within 6 months of index well-visit
Secondary outcomes:
measure: Specialty Behavioral Health Treatment Initiation
timeFrame: Within 2 years post-intervention
measure: Alcohol and other drug use
timeFrame: Use in past 6 months, at 1 and 2 years post-intervention
measure: Substance Use-related outcomes
timeFrame: in past 6 months, at 1 and 2 years post-intervention
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Stacy A Sterling
state: California
Study officials:
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