Multi-Center Trial of Limiting PGY2&3 Resident Work Hours on Patient Safety-CCC

描述（由申请人提供）： 2010年，监察长办公室估计，每年有多达18万美国人死于医疗保健，使医疗保健伤害成为全国第三大死亡原因。此外，2010年11月，Landrigan等人在《新英格兰医学杂志》上报告了一项为期6年的10个中心的医疗护理伤害研究结果;医院伤害的流行似乎有增无减。 住院医师经常性的长时间轮班可能是导致这种流行病的一个重要因素。最近，一系列的研究发现，在医学院毕业后的第一年（PGY 1），连续工作超过16个小时的反复轮班的居民比那些工作时间较短的人更严重的医疗错误，并遭受更多的职业伤害。经过长达一年的研究，包括对文献的全面审查，医学研究所（IOM）在2009年得出结论，“科学证据基础确定，人类的表现在16小时清醒后开始恶化”，并呼吁取消所有住院医生轮班，而睡眠时间不超过16小时。作为回应，从2011年7月开始，研究生医学教育认证理事会（ACGME）将限制PGY 1居民不超过16个连续工作小时。第二年（PGY 2）和更高的居民，但是，将继续工作长达28个小时连续。在选择不更实质性地限制PGY 2和更高的居民-谁代表80%的所有医生在培训-ACGME表示，这些更高级的学员采取行动的数据不足。 通过临床和转化科学奖（CTSA）资助的睡眠研究网络，美国最大的也是唯一的联邦资助的睡眠科学网络，我们建议在6个儿科ICU中进行一项多中心随机交叉试验，以比较基于睡眠和昼夜节律科学（SCS）的干预方案与包括24小时或更长时间频繁轮班的传统方案的安全性。我们将确定病人的安全（通过使用强化观察方法收集的不良事件和未遂事件的发生率来衡量），居民安全（通过基于Optalert的Johns Drowsiness Scale测量，这是一种最先进的实时驾驶安全措施），常驻睡眠（通过活动记录仪和睡眠日志测量）和居民神经行为表现（以精神警觉测试量度）在能力标准计划下有所改善。此外，我们将收集遗传材料，用于未来测试个人对睡眠剥夺和昼夜节律失调的不利影响的遗传易感性，并将开始构建和测试数学建模工具，以促进优化住院医师工作时间表的实施。这项工作将提供关于将睡眠和昼夜节律科学应用于住院医师日程安排的有效性的确切数据，鉴于住院医师在为全国最严重的患者提供护理方面发挥的关键作用，这可能会对公共卫生产生重大影响。

DESCRIPTION (provided by applicant): In 2010, the Office of the Inspector General estimated that up to 180,000 Americans die each year as a result of medical care, making harm due to medical care the 3rd leading cause of death nationwide. In addition, in November 2010, Landrigan et al. reported the results of a 10-center, 6-year study of harm due to medical care in the New England Journal of Medicine; the epidemic of harm in hospitals appeared unabated. Sleep deprivation and circadian misalignment resulting from resident physicians' recurrent extended work shifts may be an important contributor to this epidemic. Recently, a series of studies have found that residents in their first year after medical school (PGY1s) working recurrent shifts over 16 consecutive hours make more serious medical errors than do those working shorter shifts, and suffer more occupational injuries. After a year- long study that included a comprehensive review of the literature, the Institute of Medicine (IOM) concluded in 2009 that "the scientific evidence base establishes that human performance begins to deteriorate after 16 hours of wakefulness," and called for the elimination of all resident-physician shifts without sleep exceeding 16 hours. In response, beginning in July 2011, the Accreditation Council for Graduate Medical Education (ACGME) will limit PGY1 residents to no more than 16 consecutive work hours. Second year (PGY2) and higher residents, however, will continue to work for up to 28 consecutive hours. In choosing not to more substantively limit the hours of PGY2 and higher residents - who represent 80% of all physicians-in-training - the ACGME indicated that insufficient data existed on these more senior trainees to take action. Through the Clinical and Translational Science Award (CTSA)-funded Sleep Research Network, the largest and only federally funded sleep science network in the U.S., we propose to conduct a multi-center randomized crossover trial in six pediatric ICUs to compare the safety of a sleep and circadian science-based (SCS) intervention schedule with a traditional schedule that includes frequent shifts of 24 or more hours. We will determine whether patient safety (as measured by rates of adverse events and near misses, collected using an intensive observational methodology), resident safety (as measured by the Optalert-based Johns Drowsiness Scale, a state-of-the-art real-time driving safety measure), resident sleep (measured by actigraphy and sleep logs) and resident neurobehavioral performance (measure by Psychomotor Vigilance Testing) is improved under the SCS schedule. In addition, we will gather genetic material for future testing of individual genetic susceptibility to the adverse effects of sleep deprivation and circadian misalignment, and will begin building and testing mathematical modeling tools to facilitate the implementation of optimized resident work schedules. This work will provide definitive data on the effectiveness of applying sleep and circadian science to residency scheduling, which, given the key role residents play in delivering care to the nation's sickest patients, could have major public health implications.