Centralized Virtual SBIRT for Pediatric Primary Care

NCT ID: NCT06486688

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-13
• Study Completion Date: 2027-08-31

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care/Traditional SBIRT

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

Group Type: ACTIVE_COMPARATOR

Centralized Virtual SBIRT

Intervention Type: BEHAVIORAL

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

CV SBIRT

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

Group Type: EXPERIMENTAL

Centralized Virtual SBIRT

Intervention Type: BEHAVIORAL

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

Interventions

Centralized Virtual SBIRT

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaiser Permanente Division of Research

Pleasanton, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stacy A Sterling, DrPH, MSW

Role: CONTACT

Stacy.A.Sterling@kp.org

5105028619

Melanie Jackson-Morris

Role: CONTACT

melanie.j.jackson-morris@kp.org

9162040137

Facility Contacts

Stacy A Sterling, DrPH, MSW

Role: primary

Stacy.A.Sterling@kp.org

510-502-8619

Melanie Jackson-Morris

Role: backup

melanie.j.jackson-morris@kp.org

9162040137

Other Identifiers

1951166

Identifier Type: -

Identifier Source: org_study_id