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

Primary Purpose

Substance Related Disorders

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primary Care Physician
Behavioral Medicine Specialist
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Substance Related Disorders

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Stacy A Sterling

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Primary Care Physician

Behavioral Medicine Specialist

Usual Care

Arm Description

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

If the adolescent is identified at risk for substance use, the screening and brief intervention referral to treatment delivered by the behavioral medicine specialist

Care is administered as usual

Outcomes

Primary Outcome Measures

Screening rate
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
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
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
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
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
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
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
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.

Full Information

First Posted
March 20, 2015
Last Updated
July 14, 2023
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT02408952
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2011 (Actual)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Related Disorders

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9084 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary Care Physician
Arm Type
Experimental
Arm Description
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
Arm Title
Behavioral Medicine Specialist
Arm Type
Experimental
Arm Description
If the adolescent is identified at risk for substance use, the screening and brief intervention referral to treatment delivered by the behavioral medicine specialist
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Care is administered as usual
Intervention Type
Behavioral
Intervention Name(s)
Primary Care Physician
Intervention Description
The screening, brief intervention and referral to treatment is delivered by the Primary Care Physician
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Medicine Specialist
Intervention Description
The screening, brief intervention and referral to treatment is delivered by the Behavioral Medicine Specialist.
Primary Outcome Measure Information:
Title
Screening rate
Description
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.
Time Frame
Initial screening rate - at index well-visit
Title
Problem Identification rate
Description
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).
Time Frame
Initital problem identification rate - at index well-visit, following screening
Title
Assessment rate
Description
Proportion of patients screening positive for alcohol or other drug, or mental health risk, who are assessed further using the CRAFFT tool.
Time Frame
Within 2 weeks following index well-visit date
Title
Brief Intervention rate
Description
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.
Time Frame
Within 14 days of assessment at index well visit
Title
Referral to specialty treatment rate
Description
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.
Time Frame
Within 6 months of index well-visit
Secondary Outcome Measure Information:
Title
Specialty Behavioral Health Treatment Initiation
Description
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.
Time Frame
Within 2 years post-intervention
Title
Alcohol and other drug use
Description
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+).
Time Frame
Use in past 6 months, at 1 and 2 years post-intervention
Title
Substance Use-related outcomes
Description
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.
Time Frame
in past 6 months, at 1 and 2 years post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Stacy A Sterling
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States

12. IPD Sharing Statement

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Sterling S, Parthasarathy S, Jones A, Weisner C, Metz V, Hartman L, Saba K, Kline-Simon AH. Young Adult Substance Use and Healthcare Use Associated With Screening, Brief Intervention and Referral to Treatment in Pediatric Primary Care. J Adolesc Health. 2022 Oct;71(4S):S15-S23. doi: 10.1016/j.jadohealth.2021.11.033.
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Parthasarathy S, Kline-Simon AH, Jones A, Hartman L, Saba K, Weisner C, Sterling S. Three-Year Outcomes After Brief Treatment of Substance Use and Mood Symptoms. Pediatrics. 2021 Jan;147(1):e2020009191. doi: 10.1542/peds.2020-009191.
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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.
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Screening for Youth Alcohol and Drug Use: A Study of Primary Care Providers

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