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; 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.

项目摘要/摘要 这是支持父母赠款（5R01AA027253）的行政补充 修改要研究材料和程序以应对实现我们的研究的挑战 目的是源于Covid-19大流行带来的小儿初级保健的最新变化。目标 父母的赠款是测试有希望的计算机采用青少年筛查和 简短干预（CSBI）系统，旨在由小儿初级保健临床医生提供， 年龄在14-17岁的患者的随机对照试验，该试验是对筛网识别的年度待遇 AS 1）有不健康的酒精使用风险，或2）在过去的12个月中骑车而受损的驾驶员。 在约10个实践中，至少有36位儿科初级保健临床医生将被招募并随机分为 通常的护理或CSBI臂，以及至少有1,268名14-17岁的合格患者到达待遇 注册。我们的主要目的是测试CSBI对12--的青少年大量饮酒的影响 几个月的随访期。次要目的是测试CSBI对受损驾驶员骑行风险的影响或 受损时开车。该试验将在美国儿科学院（AAP）小儿进行 办公室环境研究（PRO）基于国家实践的研究网络，该网络已进行了研究 在过去的30多年中，数百种小儿做法。 CSBI系统已完成1）计算机自我 管理青少年在看到临床之前完成的筛查，2）简短互动 关于药物使用健康风险的心理教育页面，以及3）带有屏幕结果的临床医生报告表 咨询促使指导临床医生在提供合并的个性化咨询方面使用 动机采访技术。因为COVID-19大流行需要儿科实践来减少 并限制可以在实践中现场的个人数量，我们改变了研究实施 从研究人员依靠现场招聘的一项计划到可以完全远程进行的计划 与实践人员合作。此外，虽然CSBI系统最初打算在 iPad在办公室中，我们现在必须计划由于远程医疗探访患者的可能性 大流行，而不是在办公室面对面。这些变化有必要开发新在线 系统和策略将允许研究人员和远程访问进行远程研究的实施 在远程医疗就诊时，临床医生和患者的CSBI干预。行政 补充支持与创建这些新在线创建的计算机编程成本增加 通过安全的HIPAA-允许远程研究实施和干预提供的技术 在所有可能使用的可能使用的操作系统和设备上执行适当执行的​​符合性网站 练习和青少年。虽然更昂贵，但这种在线系统在长期内是有利的 随着它可以增强宽度的易于访问和传播CSBI，如果显示系统 有效的。如果有效，CSBI系统可以通过AAP教育渠道广泛传播 67,000名儿科成员，大大增加了酒精筛查的人口水平影响的潜力 以及对美国青少年的简短干预。