A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk

Boston Medical Center (BMC)

Status: Enrolling

Conditions: Overdose

Treatments: Other: Information about Naloxone; Behavioral: Brief youth overdose prevention education; Other: Usual standard of care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07022717

R61DA062217 (U.S. NIH Grant/Contract)

H-45731

Details and patient eligibility

About

Adolescent (ages 10-19) overdose deaths are the third leading cause of pediatric death and continue to rise in the United States. Healthcare providers have regular and trusted relationships with youth and have experience in providing public health injury prevention counseling. Youth have different motivations for using drugs, and many who experience fatal overdose do not have a history of opioid use. Primary care pediatric providers regularly provide developmentally appropriate injury prevention counseling for leading causes of pediatric fatal and nonfatal injury such as drowning prevention and firearms safety. However, there are no recommended, evidence-based overdose prevention interventions for youth, including in health care settings, even though research supports pediatricians and youth-serving clinicians providing harm reduction strategies such as naloxone distribution and overdose education. Among adults, overdose prevention education reduces overdose, is cost-effective, and can be learned by laypersons. Content commonly includes awareness of fentanyl in the drug supply, risk reduction (e.g., not using alone, risks of polysubstance use), and how to recognize and respond to an overdose, including the use of naloxone.

This study is a pilot two-arm cluster randomized controlled trial (RCT) of a brief overdose prevention education intervention that will be developed in collaboration with the Community Advisory Board (CAB). The primary outcome of this study is to assess the feasibility and acceptability of the brief youth overdose prevention intervention as measured by provider feasibility and acceptability as well as youth acceptability.

Enrollment: 24 estimated patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for providers:

• Physicians and advance practice providers within Pediatric Primary Care and Family Medicine at Boston Medical Center (BMC)
• ≥ 2 clinic sessions per/week

Exclusion Criteria for providers:

• None

Inclusion criteria for youth:

• Ages 13-26
• Scheduled for a comprehensive physical exam with a provider who is participating in the trial
• English speaking

Exclusion criteria for youth:

• Caregivers of youth ages 13-17 unable to provide informed consent or are not English speaking
• Cognitive limitation or intellectual disability that in the opinion of their provider would not
• Any medical/psychiatric condition that causes acute distress and requires emergency evaluation
• Under legal custody of the Department of Children and Families (DCF)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Intervention group

Experimental group

Description:

Providers randomized into this arm will complete a 45-minute intervention training. The training will occur either in person or via Zoom teleconference and include overdose prevention education, the pilot brief overdose prevention education intervention, intervention practice, and how to complete the fidelity checklist to be completed at the end of each visit.

Treatment:

Behavioral: Brief youth overdose prevention education

Other: Information about Naloxone

Control group

Active Comparator group

Description:

Providers randomized into this arm will deliver usual care to the youth patients.

Treatment:

Other: Usual standard of care