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

儿科初级保健中计算机辅助筛查和简短干预以减少未成年人饮酒：一项大型多中心随机试验

• 批准号: 10553448
• 负责人: Sion Kim Harris
• 金额: $ 19.24万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-10 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10553448
• 关键词: Academy; Achievement; Address; Administrative Supplement; Adolescent; Advisory Committees; Advocacy; American; COVID-19 pandemic; Childhood; Computers; Counseling; Development; Devices; Education; Educational process of instructing; Enrollment; Event; Goals; Health; Health Insurance Portability and Accountability Act; Impairment; Individual; Intervention; Modification; Online Systems; Operating System; Patients; Pediatric Research; Pediatrics; Persons; Population; Preventive service; Primary Health Care; Procedures; Randomized; Randomized Controlled Trials; Reporting; Research; Risk; Screening Result; Secure; Self Administration; Site; System; Techniques; Technology; Telemedicine; Testing; Visit; adolescent patient; aged; alcohol misuse; alcohol screening; alcohol screening and brief intervention; binge drinking; brief intervention; computer program; cost; design; driving safety; effectiveness testing; follow-up; impaired driving performance; implementation intervention; intervention delivery; member; motivational enhancement therapy; pandemic disease; parent grant; pediatrician; practice-based research network; psychoeducational; randomized trial; recruit; screening; screening and brief intervention; stem; substance use; treatment arm; treatment as usual; underage drinking reduction; web site

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.

项目概要/摘要 这是支持家长补助金 (5R01AA027253) 的行政补充，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 该目标源自最近因 COVID-19 大流行而给儿科初级保健带来的变化。目标 家长补助金的一部分是为了测试有前途的计算机辅助青少年筛查和 简短干预（cSBI）系统，旨在由儿科初级保健临床医生在集群中提供 随机对照试验，对象为 14-17 岁、每年进行健康检查、经筛查确定的患者 1) 有不健康饮酒的风险，或 2) 在过去 12 个月内曾与不健康的驾驶员一起骑行。在 大约 10 个诊所的至少 36 名儿科初级保健临床医生将被招募并随机分配到 Usual Care 或 cSBI 部门，以及至少 1,268 名年龄在 14 至 17 岁之间且符合条件的患者前来就诊，将接受 已注册。我们的主要目的是测试 cSBI 对青少年在 12-12 年间的间歇性酗酒的影响。 几个月的随访期。第二个目的是测试 cSBI 对与受损驾驶员或驾驶员一起骑行的风险的影响 受伤时驾驶。该试验将在美国儿科学会 (AAP) 儿科进行 办公室环境研究（PROS）国家基于实践的研究网络，该网络已在 在过去 30 多年里，进行了数百次儿科实践。 cSBI 系统由 1) 计算机自 青少年在看临床医生之前完成的筛查，2) 简短的互动 有关药物使用健康风险的心理教育页面，以及 3) 包含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，其中包括 动机访谈技巧。因为 COVID-19 大流行需要儿科实践来减少 并限制可以现场练习的人数，我们改变了我们的研究实施 计划从依赖研究人员现场招聘的计划改为可以完全远程进行的计划 与实践人员的伙伴关系。此外，虽然 cSBI 系统最初打算在 由于办公室里有 iPad，我们现在必须计划一下患者在远程医疗就诊中看到的可能性，因为 流行病，而不是亲自到办公室。这些变化需要开发新的在线服务 允许研究人员进行远程研究和远程访问的系统和策略 临床医生和患者在远程医疗就诊时进行 cSBI 干预。行政方面 补充支持与创建这些新的在线内容相关的增加的计算机编程成本 允许通过安全的 HIPAA 进行远程研究实施和干预提供的技术 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 跨越实践和青少年。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，如果该系统被展示 有效的。如果有效，cSBI 系统可以通过 AAP 教育渠道广泛传播给其 67,000 名儿科医生会员，大大增加了酒精筛查对人群影响的潜力 以及对美国青少年的简短干预。