Clinical trial NCT06486688: Centralized Virtual SBIRT for Pediatric Primary Care
Official title: Virtual SBIRT for Pediatric Primary Care: Increasing Access to Screening, Brief Intervention and Referral to Treatment for Alcohol and Other Drug Use Via Telehealth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Alcohol Use
Mental Health Issue
Alcohol Related Disorders
Adolescents
Keywords: Adolescents
Alcohol
SBIRT
Screening
Drug
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 22320
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Referrals to behavioral health clinicians for SBIRT
timeFrame: During the 2 year intervention period
measure: Brief Interventions
timeFrame: During the 2-year intervention period
measure: Referrals
timeFrame: During the 2-year intervention period
measure: Specialty Treatment Initiation
timeFrame: Within 2 months of the index screening visit.
measure: Specialty Treatment Engagement
timeFrame: Within 34 days of the initial specialty care initiation encounter.
measure: AOD and Mental Health Diagnoses
timeFrame: within 1 year and 2 years of the index screening visit
measure: Alcohol and other drug use
timeFrame: 1- and 2-year follow-up visits.
measure: Depressive symptoms
timeFrame: 1- and 2-year follow-up visits.
measure: Suicidality
timeFrame: 1- and 2-year follow-up visits.
measure: Health Services Utilization
timeFrame: Within 1 year and 2 years of the index screening visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: Kaiser Permanente Division of Research
state: California
Study officials:
References: