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

项目总结/摘要 这是一个行政补充，以支持父母补助金（5 R 01 AA 027253），允许 对研究材料和程序进行修改，以应对实现我们研究的挑战 我们的目标源于最近COVID-19大流行带来的儿科初级保健变化。目标 父母补助金的目的是测试一种有前途的计算机辅助青少年筛查和 简短干预（cSBI）系统，专为儿科初级保健临床医生提供，在一个集群- 在筛选确定的14-17岁患者中进行的一项随机对照试验， 1）有不健康的酒精使用风险或2）在过去12个月内与受损的司机一起骑行。在 将招募约10个诊所的至少36名儿科初级保健临床医生，并随机分配至 患者护理或cSBI组，至少有1，268名14-17岁的合格患者将接受井访视， 注册了我们的主要目的是测试cSBI对青少年重度间歇性饮酒的影响， 个月的随访期。第二个目的是测试cSBI对与受损驾驶员一起骑行的风险的影响， 驾驶时受损。这项试验将在美国儿科学会（AAP）儿科 办公室环境研究（PROS）国家实践研究网络，该网络在以下领域开展了研究： 在过去的30多年里，有数百个儿科实践。cSBI系统由1）计算机自 青少年在看医生之前完成的管理筛选，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）带有筛查结果的临床医生报告表 以及指导临床医生提供个性化咨询的咨询提示， 动机面试技巧由于COVID-19大流行需要儿科实践来减少 并限制可以在实践现场的人数，我们改变了我们的研究实施 计划从一个依赖于研究人员现场招募的计划转变为一个可以完全远程进行的计划， 与实践人员的合作伙伴关系。此外，虽然cSBI系统最初打算在 iPad在办公室，我们现在必须计划的可能性，病人被视为在远程医疗访问，由于 而不是在办公室里亲自进行。这些变化需要开发新的在线 允许研究人员实施远程研究和远程访问的系统和战略 临床医生和患者在远程医疗访问中进行cSBI干预。行政 补充支持增加计算机编程成本与创建这些新的在线 通过安全的HIPAA实现远程研究实施和干预交付的技术- 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 在实践和青少年中。虽然成本较高，但从长远来看，这种在线系统是有利的 因为它提高了cSBI的广泛访问和传播的便利性，如果该系统显示 有效如果有效，cSBI系统可以通过AAP教育渠道广泛传播， 67，000名儿科医生成员，大大增加了酒精筛查对人口水平影响的潜力 和对美国青少年的简短干预。

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.