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

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ClinicalTrials.gov Identifier: NCT02408952

Recruitment Status : Active, not recruiting

First Posted : April 6, 2015

Last Update Posted : September 3, 2020

Sponsor:

Information provided by (Responsible Party):

Kaiser Permanente

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	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
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 :	October 2011
Actual Primary Completion Date :	October 2013
Estimated Study Completion Date :	June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse

U.S. FDA Resources

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

Outcome Measures

Primary Outcome Measures :

Screening rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:	12 Years to 80 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408952

Locations

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United States, California
Stacy A Sterling
Oakland, California, United States, 94612

Sponsors and Collaborators

Kaiser Permanente

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sterling S, Kline-Simon AH, Weisner C, Jones A, Satre DD. Pediatrician and Behavioral Clinician-Delivered Screening, Brief Intervention and Referral to Treatment: Substance Use and Depression Outcomes. J Adolesc Health. 2018 Apr;62(4):390-396. doi: 10.1016/j.jadohealth.2017.10.016. Epub 2018 Feb 1.

Sterling S, Kline-Simon AH, Jones A, Satre DD, Parthasarathy S, Weisner C. Specialty addiction and psychiatry treatment initiation and engagement: Results from an SBIRT randomized trial in pediatrics. J Subst Abuse Treat. 2017 Nov;82:48-54. doi: 10.1016/j.jsat.2017.09.005. Epub 2017 Sep 10.

Sterling S, Kline-Simon AH, Satre DD, Jones A, Mertens J, Wong A, Weisner C. Implementation of Screening, Brief Intervention, and Referral to Treatment for Adolescents in Pediatric Primary Care: A Cluster Randomized Trial. JAMA Pediatr. 2015 Nov;169(11):e153145. doi: 10.1001/jamapediatrics.2015.3145. Epub 2015 Nov 2.

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Responsible Party:	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT02408952
Other Study ID Numbers:	11-07796
First Posted:	April 6, 2015 Key Record Dates
Last Update Posted:	September 3, 2020
Last Verified:	September 2020

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

Layout table for MeSH terms

Substance-Related Disorders Chemically-Induced Disorders Mental Disorders

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