ABSTRACT
Introduction: School based health centers (SBHCs) are comprehensive primary care facilities that reduce barriers to education by providing in-school access to healthcare. Students enrolled in SBHCs can access confidential healthcare independently during school hours - making SBHCs an ideal setting to address substance use. SBHC providers report lack of time, training, and treatment access as implementation barriers to screening, brief intervention, and referral to treatment (SBIRT) for alcohol and other substance use. We describe the implementation of a novel telemedicine-based adolescent addiction medicine consult service for middle and high school students within SBHCs. Method(s): In January 2020, the Yale Program in Addiction Medicine, Fair Haven Community Health Care (FHCHC;a federally qualified health center), and Yale Department of Pediatrics partnered to integrate substance use screening, treatment, and prevention services into pediatric primary care. FHCHC provides medical and behavioral healthcare to over 18,000 pediatric patients across 14 sites, including 6 middle and high school based SBHCs. From January to March 2020, the SBHC providers, leadership from pediatrics, and a pediatrician board certified in addiction-medicine used a partnered, consensus building approach to establish an SBHC-integrated adolescent addiction medicine outpatient consult service. Protocols were created to standardize: 1) Referral criteria (at risk for suspension due to substance use (including vaping), positive screen for substance use, >= monthly use of any substance);2) referral and scheduling (EHR-based referral system, direct scheduling of appointments);3) overall principles of care (up to 6 sessions of voluntary and confidential care, encouraging parental involvement and linkage to ongoing mental health and substance use treatment services);4) infrastructure needs (tele-video enabled, internet-connected device, private room in the SBHC for patient);5) staffing needs (one pediatric addiction medicine specialist, one SBHC healthcare provider, and one support staff );and 6) SBHC training needs (education on best practices for screening, how to describe service to students, parents and administrators). Given the ongoing COVID-19 pandemic and local addiction medicine workforce capacity, the service was designed to occur via telemedicine with a pediatrician board-certified in addiction medicine or a family-medicine-trained addiction medicine fellow. Result(s): Starting in March 2020, Adolescent Addiction Medicine Tele-Consult Services were available during one four-hour block/week when school was in session. Between March 2020 and December 2021, the service completed 57 encounters with 25 adolescents aged 13-18 years. Telemedicine encounters lasted 20-40 minutes and the student completed the visit in a private room within the SBHC during school hours. Services included: diagnosis of substance use disorders, psychoeducation, referral to and coordination with mental health services, nicotine use disorder treatment with medications, harm reduction and return to use prevention counseling. Diagnoses included: Nicotine use disorder (vaping) (n = 9 patients), cannabis use disorder (n = 5), alcohol use (n = 7), nicotine use (n = 8), cannabis use (n = 11) and prescription opioid misuse (n = 2). Conclusion(s): Here we describe the development and early implementation of an Adolescent Addiction Medicine Tele-Consult Service within SBHCs. Next steps for program development include formal tracking of patient-level outcomes, evaluations of acceptability among adolescents, SBHCs and schools, and further development of training opportunities for residents and fellows.
ABSTRACT
Background. Casirivimab and imdevimab (CAS/IMDEV) is authorized for emergency use in the US for outpatients with COVID-19. We present results from patient cohorts receiving low flow or no supplemental oxygen at baseline from a phase 1/2/3, randomized, double-blinded, placebo (PBO)-controlled trial of CAS/IMDEV in hospitalized patients (pts) with COVID-19. Methods. Hospitalized COVID-19 pts were randomized 1:1:1 to 2.4 g or 8.0 g of IV CAS/IMDEV (co-administered) or PBO. Primary endpoints were time-weighted average (TWA) change in viral load from baseline (Day 1) to Day 7;proportion of pts who died or went on mechanical ventilation (MV) through Day 29. Safety was evaluated through Day 57. The study was terminated early due to low enrollment (no safety concerns). Results. Analysis was performed in pooled cohorts (low flow or no supplemental oxygen) as well as combined treatment doses (2.4 g and 8.0 g). The prespecified primary virologic analysis was in seronegative (seroneg) pts (combined dose group n=360;PBO n=160), where treatment with CAS/IMDEV led to a significant reduction in viral load from Day 1-7 (TWA change: LS mean (SE): -0.28 (0.12);95% CI: -0.51, -0.05;P=0.0172;Fig. 1). The primary clinical analysis had a strong positive trend, though it did not reach statistical significance (P=0.2048), and 4/6 clinical endpoints prespecified for hypothesis testing were nominally significant (Table 1). In seroneg pts, there was a 47.0% relative risk reduction (RRR) in the proportion of pts who died or went on MV from Day 1-29 (10.3% treated vs 19.4% PBO;nominal P=0.0061;Fig. 2). There was a 55.6% (6.7% treated vs 15.0% PBO;nominal P=0.0032) and 35.9% (7.3% treated vs 11.5% PBO;nominal P=0.0178) RRR in the prespecified secondary endpoint of mortality by Day 29 in seroneg pts and the overall population, respectively (Fig. 2). No harm was seen in seropositive patients, and no safety events of concern were identified. Conclusion. Co-administration of CAS/IMDEV led to a significant reduction in viral load in hospitalized, seroneg pts requiring low flow or no supplemental oxygen. In seroneg pts and the overall population, treatment also demonstrated clinically meaningful, nominally significant reductions in 28-day mortality and proportion of pts dying or requiring MV.