A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk Aim 3
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 648
- 试验地点
- 1
- 主要终点
- Provider Fidelity to the Intervention
研究概览
简要总结
Between 2015 and 2019, overdose deaths translated to 1.25 million years of life lost among adolescents and young adults (youth) aged 12 to 24 years, and the percent change in fatal overdose rates among adolescents ages 14 to 18 was higher than adults between 2019 and 2020.3-5 Primary care providers are uniquely positioned to provide evidence-based information to youth to both improve awareness of overdose risk (individual benefit) and simultaneously ensure that youth are prepared to recognize and respond to an overdose (public health benefit). However, currently there is no evidence-based intervention for pediatric primary care to reduce youth overdose risk and ensure youth can recognize and respond to an overdose.
To address the gap in evidence-based overdose prevention interventions for youth, the investigators propose a randomized controlled trial (RCT) to evaluate the efficacy of a brief universal overdose prevention intervention in pediatric primary care. 24 providers and 624 youth patient participants randomized (at the provider level) to receive either the brief overdose prevention intervention or usual care will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physicians and advance practice providers (nurse practitioners and physician assistants) within Pediatric Primary Care and Family Medicine at Boston Medical Center, NeighborHealth, and South Boston Community Health Center
- •≥ 1 clinic session per week
- •Ages 13 - 26
- •Scheduled for a CPE or follow-up clinical appointment with a provider who is participating in the trial
- •English speaking
排除标准
- •Participated as an intervention provider in the R61 pilot RCT (H-45731)
- •Participated in the Community Advisory Board that assisted in the development of the intervention (H-45388)
- •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 be able to complete the requirements of the research
- •Young adults ages 18-26 with a legal guardian
- •Any medical/psychiatric condition that causes acute distress and requires emergency evaluation
- •Under legal custody of the Department of Children and Families (DCF)
- •Participated in the intervention arm of the R61 pilot RCT (H-45731)
研究组 & 干预措施
Intervention group
Providers randomized to the intervention group will complete two 30-minute trainings in person or over Teams via videoconference. In the first training, providers will receive overdose prevention education and learn about the brief overdose prevention intervention. In the second training, providers will practice conducting the intervention and filling out the fidelity checklist that will be completed at the end of each appointment.
干预措施: Brief youth overdose prevention education (Behavioral)
Control group
Providers randomized to the control group will conduct the youths' comprehensive physical exam (CPE) or follow-up clinical appointment as usual.
干预措施: Usual Standard of Care (Other)
结局指标
主要结局
Provider Fidelity to the Intervention
时间窗: 12 months
Providers in the intervention arm will complete a checklist after all CPEs and follow-up clinical appointments with youth ages 13 to 26 years. The checklist will assess provider consistency in delivery of the intervention including adherence to intervention topics and the provision of naloxone.
Youth Fidelity to the Intervention
时间窗: 12 months
Youth in the intervention arm will complete a checklist after their CPEs and follow-up clinical appointments. The checklist will assess consistency in intervention delivery including adherence to intervention topics and whether naloxone was offered to the youth.
Youth knowledge of risk associated with exposure to fentanyl and other emerging drugs
时间窗: Baseline, 3 months, 6 months, 9 months, and 12 months.
Assessed using a 4-point Likert-scale question measuring perceived risk of harm from taking prescription medication that was not prescribed or taking medication other than prescribed.
次要结局
- Youth knowledge of strategies to reduce overdose risk(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Youth's ability to recognize and respond to an overdose(Baseline, 3 months, 6 months, 9 months, and 12 months.)