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，使医疗保健造成的伤害成为全国第三大死因。此外，2010年11月，Landrigan et al.《新英格兰医学杂志》报道了一项为期6年、由10个中心进行的关于医疗伤害的研究结果；医院中的伤害流行病似乎有增无减。住院医生反复延长工作班次导致的睡眠不足和昼夜节律失调可能是导致这一流行病的重要因素。最近，一系列研究发现，医学院毕业第一年的住院医生(PGY1)连续轮班工作超过16小时，比那些工作时间更短的人犯更严重的医疗错误，遭受更多的职业伤害。经过长达一年的研究，其中包括对文献的全面回顾，医学研究所(IOM)在2009年得出结论，“科学证据基础表明，人类在16小时清醒后表现开始恶化”，并呼吁取消所有不超过16小时睡眠的住院医生轮班。作为回应，从2011年7月开始，医学研究生教育认证委员会(ACGME)将限制PGY1住院医生的连续工作时间不超过16个小时。然而，第二年(PGY2)和更高级别的居民将继续工作长达28小时。ACGME选择不对PGY2和更高级别的住院医生--占所有受训医生的80%--的时间进行更实质性的限制，这表明关于这些更高级的受训人员的数据不足，无法采取行动。通过临床和翻译科学奖(CTSA)资助的睡眠研究网络(美国最大也是唯一由联邦政府资助的睡眠科学网络)，我们提议在六个儿科ICU进行一项多中心随机交叉试验，以比较基于睡眠和昼夜科学(SCS)的干预计划与包括24小时或更长频繁轮班的传统计划的安全性。我们将确定在SCS计划下，患者安全(通过使用密集观察方法收集的不良事件和险些发生的比率来衡量)、居民安全(通过基于Optalert的Johns昏昏量表(一种最先进的实时驾驶安全衡量标准)衡量)、居民睡眠(通过活动记录和睡眠记录衡量)和居民神经行为表现(通过精神运动警觉性测试衡量)是否有所改善。此外，我们将收集遗传物质，用于未来测试个人对睡眠不足和昼夜节律失调不利影响的遗传易感性，并将开始建立和测试数学建模工具，以促进实施优化的驻地工作时间表。这项工作将提供明确的数据，说明将睡眠和昼夜节律科学应用于住院医生日程安排的有效性，鉴于住院医生在向全国病情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.