Centralized Virtual SBIRT for Pediatric Primary Care

NCT06486688 | Recruiting

• 1 other identifier: 1951166
• Study Type: interventional
• Target: 22,320
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescent alcohol and other drug (AOD) use is a significant public health problem which contributes to high levels of mortality, morbidity and healthcare costs in young people, and identification and early intervention for these problems is critical to improving outcomes. Screening, Brief Intervention and Referral to Treatment (SBIRT) in pediatric primary care is an evidence-based strategy for addressing these problems, but has not been widely and systematically implemented, for a variety of reasons, including lack of training and staffing resources to support its implementation. This pragmatic, Type 1 Hybrid Comparative Effectiveness Implementation study will examine whether a centralized, virtually-delivered modality of SBIRT, rapidly accessible by multiple pediatric primary care clinics, can be cost-effectively implemented to improve early identification and treatment for AOD use and comorbid mental health problems among adolescents identified as being at high or severe risk of AOD use disorder during adolescent Well Visits.

Conditions

Adolescent Alcohol Use; Mental Health Issue; Alcohol Related Disorders; Adolescents

Keywords

Adolescents; Alcohol; SBIRT; Screening; Drug

Outcome Measures

Primary Outcomes (10)

• Referrals to behavioral health clinicians for SBIRT

  Patients seen by behavioral health clinicians in both intervention arms will be determined via appointment codes

  During the 2 year intervention period

• Brief Interventions

  Brief Interventions will be documented in the Electronic Health Record via administrative Z-codes within 1 week of the index screening visit.

  During the 2-year intervention period

• Referrals

  Referrals to specialty treatment will be coded using the electronic referral program in the Electronic Health Records within 1 week of the Brief Intervention.

  During the 2-year intervention period

• Specialty Treatment Initiation

  Initiation is defined as at least 1 visit to specialty treatment (Addiction Medicine or Child \& Adolescent Psychiatry).

  Within 2 months of the index screening visit.

• Specialty Treatment Engagement

  Engagement is defined as 2 or more specialty treatment encounters.

  Within 34 days of the initial specialty care initiation encounter.

• AOD and Mental Health Diagnoses

  Clinical International Classification of Diseases-10 AOD, depression, and anxiety diagnoses

  within 1 year and 2 years of the index screening visit

• Alcohol and other drug use

  Alcohol and other drug use will be measured by the Screening to Brief Intervention (S2BI) screening tool: "In the past year, how many times have you used: alcohol, marijuana (smoked, edible, dabs), tobacco (cigarettes), vaping nicotine, vaping marijuana, other substances?" Responses: never, once or twice, monthly, weekly or more

  1- and 2-year follow-up visits.

• Depressive symptoms

  Prior two-week depression measures via the Patient Health Questionnaire-2, a validated and commonly used screener for depression: "Over the last 2 weeks how often have you been bothered by the following problems? 1)Little interest or pleasure in doing things; 2) Feeling down, depressed or hopeless?" - Responses: not at all, several days, more than half the days, nearly every day

  1- and 2-year follow-up visits.

• Suicidality

  Suicidality measured by: Have you thought seriously about killing yourself, made a plan, or tried to kill yourself? Responses: Y/N

  1- and 2-year follow-up visits.

• Health Services Utilization

  The number of inpatient and Emergency Department encounters

  Within 1 year and 2 years of the index screening visit.

Study Arms (2)

Usual Care/Traditional SBIRT

ACTIVE COMPARATOR

Clinics where appointment-based brief interventions are delivered by a behavioral health clinician assigned to the clinic (Traditional SBIRT arm)

Behavioral: Centralized Virtual SBIRT

CV SBIRT

EXPERIMENTAL

Clinics where brief interventions are delivered virtually by video or telephone by a centralized behavioral health clinician (CV-SBIRT arm)

Behavioral: Centralized Virtual SBIRT

Interventions

Centralized Virtual SBIRT BEHAVIORAL

Brief interventions are delivered virtually by video or telephone by a centralized behavioral health clinician

CV SBIRT; Usual Care/Traditional SBIRT

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The sample will include all adolescents aged 12 through 17 years seen for a Well Visit, who are at risk of AOD use disorder defined as endorsing monthly or more frequent AOD use OR any AOD use and past-two-week depressive symptoms or suicidality.

You may not qualify if:

• N/A - all adolescents with a Well Visit are eligible

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Division of Research

Pleasanton, California, 94588, United States

RECRUITING

MeSH Terms

Conditions

Underage Drinking; Alcohol-Related Disorders

Condition Hierarchy (Ancestors)

Adolescent Behavior; Behavior; Alcohol Drinking; Drinking Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Stacy A Sterling, DrPH, MSW

CONTACT

5105028619; Stacy.A.Sterling@kp.org

Melanie Jackson-Morris

CONTACT

9162040137; melanie.j.jackson-morris@kp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: July 3, 2024
• Study Start: February 13, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)