Computer-facilitated Screening and Brief Intervention in pediatric primary care to reduce underage drinking: a large multi-site randomized trial

项目摘要/摘要 这是一项行政补充，以支持家长资助(5R01AA027253)，该资助允许 将对研究材料和程序进行修改，以应对对我们研究成果的挑战 旨在应对最近新冠肺炎大流行带来的儿科初级保健方面的变化。目标是 家长拨款的一部分是测试一项前景光明的计算机辅助青少年筛查和 短暂干预(CSBI)系统，旨在由儿科初级保健临床医生以集群形式提供- 对14-17岁经筛查确定的患者进行年度探视的随机对照试验 1)存在不健康饮酒的风险，或2)在过去12个月内与受损的司机一起骑车。在… 将招募约10家诊所的至少36名儿科初级保健临床医生，并随机分为 通常护理或cSBI ARM，他们的至少1,268名年龄在14-17岁之间的符合条件的患者将抵达探井 已注册。我们的主要目标是测试cSBI对青少年在12-12岁期间大量饮酒的影响。 3个月的随访期。第二个目的是测试cSBI对与受损司机或 在受损的情况下驾驶。这项试验将在美国儿科学会(AAP)儿科学会进行 办公室环境研究(PROS)以实践为基础的国家研究网络，在 在过去的30年里，有数百家儿科诊所。CSBI系统由1)计算机自身组成 青少年在看临床医生之前完成的筛查，2)简短的互动 关于物质使用健康风险的心理教育页面，以及3)带有筛选结果的临床医生报告表 以及咨询提示，用于指导临床医生提供个性化咨询，包括 激励性面试技巧。因为新冠肺炎大流行需要儿科实践来减少 并限制了可以在现场练习的个人数量，我们改变了研究实施 从依赖研究人员现场招聘的计划转变为完全可以在 与实习人员建立伙伴关系。此外，虽然cSBI系统最初打算在 IPad在办公室，我们现在必须为患者在远程医疗访问中被看到的可能性做好计划，因为 大流行，而不是在办公室里面对面。这些变化需要发展新的在线 允许研究人员实施远程研究和远程访问的系统和策略 在远程医疗访问的情况下，由临床医生和患者共同参与cSBI的干预。行政部门 附录支持与创建这些新的在线产品相关的增加的计算机编程成本 允许通过安全的HIPAA实施远程研究和干预交付的技术- 可在所有可能使用的操作系统和设备上正常运行的合规网站 在实践和青少年之间。虽然成本更高，但从长远来看，这样的在线系统是有利的 由于它提高了广泛获取和传播cSBI的便利性，如果显示该系统， 有效。如果有效，cSBI系统可以通过aap教育渠道广泛传播给 67,000名儿科医生成员，极大地增加了酒精筛查对人群的潜在影响 并对美国青少年进行短暂干预。

PROJECT SUMMARY/ABSTRACT This is an administrative supplement in support of the parent grant (5R01AA027253) which allows modifications to be made to study materials and procedures to address challenges to achievement of our study aims stemming from recent changes in pediatric primary care brought on by the COVID-19 pandemic. The goal of the parent grant is to test the effectiveness of a promising computer-facilitated adolescent Screening and Brief Intervention (cSBI) system, designed for delivery by pediatric primary care clinicians, in a cluster- randomized controlled trial in patients aged 14-17 years arriving for annual well-visits who are screen-identified as 1) at risk for unhealthy alcohol use or 2) having ridden in the past 12 months with an impaired driver. At least 36 pediatric primary care clinicians across ~10 practices will be recruited and randomized into either a Usual Care or cSBI arm, and at least 1,268 of their eligible patients aged 14-17 arriving for well-visits will be enrolled. Our primary aim is to test the effect of cSBI on adolescents’ heavy episodic drinking during a 12- months follow-up period. A secondary aim is to test the effect of cSBI on risk of riding with an impaired driver or driving while impaired. This trial will be conducted in the American Academy of Pediatrics’ (AAP) Pediatric Research in Office Settings (PROS) national practice-based research network which has conducted studies in hundreds of pediatric practices over the past 30+ years. The cSBI system is comprised of 1) computer self- administered screening that adolescents complete prior to seeing their clinician, 2) brief interactive psychoeducational pages on substance use health risks, and 3) a Clinician Report Form with screen results and counseling prompts that guide clinicians use in providing individualized counseling that incorporates motivational interviewing techniques. Because the COVID-19 pandemic required pediatric practices to reduce and limit the number of individuals that can be on-site at practices, we transformed our study implementation plan from one that relied on on-site recruitment by study staff to one that can be conducted entirely remotely in partnership with practice staff. In addition, while the cSBI system was initially intended to be delivered on an iPad in the office, we now have to plan for the possibility of patients being seen in telemedicine visits due to the pandemic, rather than in-person in the office. These changes necessitated the development of new online systems and strategies that would allow for remote study implementation by research staff and remote access to the cSBI intervention by both clinicians and patients in the event of telemedicine visits. The administrative supplement supports the increased computer programming costs associated with creation of these new online technologies that allow remote study implementation and intervention delivery through secure HIPAA- compliant websites that perform appropriately on all possible operating systems and devices that may be used across practices and adolescents. While more costly, such an online system is advantageous in the long-term as it enhances ease of widespread access to and dissemination of cSBI, should the system be shown effective. If effective, the cSBI system could be widely disseminated through AAP educational channels to its 67,000 pediatrician members, greatly increasing the potential for population-level impact of alcohol screening and brief intervention for U.S. adolescents.