Centralized Virtual SBIRT for Pediatric Primary Care

Virtual SBIRT for Pediatric Primary Care: Increasing Access to Screening, Brief Intervention and Referral to Treatment for Alcohol and Other Drug Use Via Telehealth

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Related Disorders; Mental Health Issue; Adolescents; Adolescent Alcohol Use
• Intervention / Treatment: Behavioral: Centralized Virtual SBIRT

Detailed Description

Adolescent alcohol and other drug (AOD) use is a major public health concern posing significant challenges to healthcare providers, patients and families. It is associated with comorbid psychiatric and medical conditions, poor educational and employment outcomes, accidents and injuries, and avoidable health services utilization and costs (e.g., emergency and inpatient). Early AOD use initiation is associated with alcohol use disorders in adulthood. Screening, Brief Intervention and Referral to Treatment (SBIRT) delivered in pediatric primary care is an effective approach to early identification and intervention and can reduce both AOD use and consequences and co-occurring mental health symptoms, yet widespread implementation is lacking, due to a variety of barriers, including the time constraints and competing priorities faced by pediatricians and lack of trained staff. Research on efficient and cost-effective modalities of SBIRT delivery in pediatric primary care is critical to expanding the evidence base and supporting broader implementation. Accelerated by the pandemic, behavioral telemedicine approaches to addressing adolescent AOD use, and mental health problems are gaining momentum and offer the potential to increase the reach and impact of SBIRT in pediatric primary care. This study's objective is to 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 and comorbid mental health problems among adolescents at high or severe risk of AOD use disorder. In this wholly pragmatic, Type 1 Hybrid Comparative Effectiveness Implementation study, set in a large, real-world health system with a highly diverse population, we will compare outcomes in two models of busy, general pediatric primary care clinics with an eligible population of approximately 22,320 12-17 year old adolescents: 1) clinics where brief interventions are delivered virtually by video or telephone by a centralized behavioral health clinician (CV-SBIRT arm), or 2) clinics where appointment-based brief interventions are delivered by a behavioral health clinician assigned to the clinic (Traditional SBIRT arm).

• Study Type: Interventional
• Enrollment (Estimated): 22320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stacy A Sterling, DrPH, MSW; Phone Number: 5105028619; Email: Stacy.A.Sterling@kp.org
• Study Contact Backup: Name: Melanie Jackson-Morris; Phone Number: 9162040137; Email: melanie.j.jackson-morris@kp.org

Study Locations

• United States
  • California
    • Pleasanton, California, United States, 94588
      • Recruiting
      • Kaiser Permanente Division of Research
      • Contact: Melanie Jackson-Morris; Phone Number: 9162040137; Email: melanie.j.jackson-morris@kp.org
      • Contact: Stacy A Sterling, DrPH, MSW; Phone Number: 510-502-8619; Email: Stacy.A.Sterling@kp.org
      • Principal Investigator: Stacy A Sterling, DrPH, MSW

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care/Traditional SBIRT; Clinics where appointment-based brief interventions are delivered by a behavioral health clinician assigned to the clinic (Traditional SBIRT arm)	Behavioral: Centralized Virtual SBIRT; Brief interventions are delivered virtually by video or telephone by a centralized behavioral health clinician
Experimental: CV SBIRT; Clinics where brief interventions are delivered virtually by video or telephone by a centralized behavioral health clinician (CV-SBIRT arm)	Behavioral: Centralized Virtual SBIRT; Brief interventions are delivered virtually by video or telephone by a centralized behavioral health clinician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Screening; Alcohol; SBIRT; Drug
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Substance-Related Disorders; Alcohol Drinking; Alcohol-Related Disorders; Underage Drinking
• Other Study ID Numbers: 1951166

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No