Screening for Youth Alcohol and Drug Use: A Study of Primary Care Providers

Sponsor

Kaiser Permanente (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02408952

Collaborator

(none)

9,084

Enrollment

Location

Arms

140

Duration (Months)

64.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Substance Related Disorders	Behavioral: Primary Care Physician Behavioral: Behavioral Medicine Specialist	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

9084 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Screening for Youth Alcohol and Drug Use: A Study of Primary Care Providers

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Oct 1, 2013

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Primary Care Physician 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	Behavioral: Primary Care Physician The screening, brief intervention and referral to treatment is delivered by the Primary Care Physician
Experimental: Behavioral Medicine Specialist 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: Behavioral Medicine Specialist The screening, brief intervention and referral to treatment is delivered by the Behavioral Medicine Specialist.
No Intervention: Usual Care Care is administered as usual

Arm

Intervention/Treatment

Experimental: Primary Care Physician

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

Behavioral: Primary Care Physician

The screening, brief intervention and referral to treatment is delivered by the Primary Care Physician

Experimental: Behavioral Medicine Specialist

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: Behavioral Medicine Specialist

The screening, brief intervention and referral to treatment is delivered by the Behavioral Medicine Specialist.

No Intervention: Usual Care

Care is administered as usual

Outcome Measures

Primary Outcome Measures

Screening rate [Initial screening rate - at index well-visit]
The proportion of patients who are screened with the Teen Well Check Questionnaire AOD use or Mood symptom questions, among all patients with Teen well-child visits.
Problem Identification rate [Initital problem identification rate - at index well-visit, following screening]
The proportion of patients screened who answer "yes" to AOD use or Mood symptoms in past 12 months and "yes" to at least one non-car CRAFFT question. (Being in a car with someone using AOD may not be related to child's problem, but to having a parent/other adult who has driven while drinking/using).
Assessment rate [Within 2 weeks following index well-visit date]
Proportion of patients screening positive for alcohol or other drug, or mental health risk, who are assessed further using the CRAFFT tool.
Brief Intervention rate [Within 14 days of assessment at index well visit]
The proportion of patients who receive an intervention within 14 days, among those who are identified with AOD risk (based on CRAFFT score). Documented in EHR by clinicians, using an ICD-9 Administrative V-code for substance use counseling or behavioral counseling.
Referral to specialty treatment rate [Within 6 months of index well-visit]
The proportion of patients who receive referrals to specialty behavioral health treatment, among those identified through the CRAFFT as needing such treatment. Documented in the EHR.

Secondary Outcome Measures

Specialty Behavioral Health Treatment Initiation [Within 2 years post-intervention]
Defined as the percent referred, who have at least one specialty behavioral health visit among those identified with a behavioral health problem. Documented in the EHR.
Alcohol and other drug use [Use in past 6 months, at 1 and 2 years post-intervention]
Alcohol and drug use: The items in the EHR measure past 30-day and 6-month use of alcohol, marijuana and other drugs and tobacco, including days of use, quantity consumed (any, 3+ and 5+ drinks), and days of binge drinking (3+ and 5+).
Substance Use-related outcomes [in past 6 months, at 1 and 2 years post-intervention]
AOD-related legal, school, and family problems: The EHR questions also include measures from the Comprehensive Adolescent Severity Inventory (CASI),148 a semi-structured questionnaire which measures adolescent health and functioning across education, legal, and family relations domains.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stacy A Sterling	Oakland	California	United States	94612

Sponsors and Collaborators

Kaiser Permanente

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Kaiser Permanente

ClinicalTrials.gov Identifier:

NCT02408952

Other Study ID Numbers:

11-07796

First Posted:

Apr 6, 2015

Last Update Posted:

Sep 8, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Substance-Related Disorders

Study Results

No Results Posted as of Sep 8, 2021