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

项目总结/文摘

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.