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

限制PGY2的多中心试验

基本信息

批准号：
8544488
负责人：
Charles A Czeisler
金额：
$ 160.51万
依托单位：
BRIGHAM AND WOMEN'S HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-09-15 至 2017-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8544488
关键词：
ABCB1 gene Accreditation Address Adverse effects Adverse event Affect American Automobile Driving Award Caring Cause of Death Childhood Chronic Circadian Rhythms Clinical Sciences Communities Critical Care Cross-Over Studies Data Databases Drowsiness Effectiveness Epidemic Failure Fatigue Funding Future Genetic Materials Genetic Predisposition to Disease Home environment Hospitals Hour Human Individual Injury Institute of Medicine (U.S.)Intensive Care Units Intervention Journals Knowledge Laboratories Lead Measures Medical Medical Errors Medicine Methodology New England Occupational Occupations Patient Care Patients Performance Physicians Play Policies Policy Maker Provider Public Health Randomized Reaction Time Recurrence Reporting Research Residencies Review Literature Risk Safety Saliva Sampling Schedule Science Series Sleep Sleep Deprivation Testing Time Training Translational Research Vehicle crash Visual Wakefulness Work Wrist abstracting actigraphy alertness base care systems evidence base experience graduate medical education improved injured mathematical model medical schools neurobehavioral patient safety response satisfaction shift work tool vigilance

项目摘要

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.

描述（由申请人提供）： 2010年，监察长办公室估计，由于医疗服务，每年多达18万美国人死亡，由于医疗而造成伤害，这是全国第三大死亡原因。此外，2010年11月，Landrigan等人。报道了新英格兰医学杂志上一项为期10个中心的6年伤害研究的结果；医院的伤害流行似乎没有减弱。居民医师经常发生的延长工作转变导致的睡眠剥夺和昼夜节律不对对准可能是这种流行病的重要原因。最近，一系列的研究发现，在医学院（PGY1）连续16个小时内进行反复转变后的第一年，居民比那些工作较短的转变并遭受更多职业伤害的居民会导致更严重的医疗错误。经过一年的研究，包括对文献进行全面综述的研究，医学研究所（IOM）在2009年得出结论，“科学证据基础确定，在清醒16个小时后，人类的绩效开始恶化”，并呼吁消除所有居民 - 医学家的转变，而无需超过16个小时的睡眠。作为回应，从2011年7月开始，研究生医学教育认证委员会（ACGME）将连续限制PGY1居民连续16个工作时间。但是，第二年（PGY2）和更高的居民将连续长达28个小时继续工作。 ACGME在选择不更加实质性地限制PGY2和更高居民的小时时间（占所有培训医生的80％）表明，这些更多的高级学员的数据不足以采取行动。通过临床和转化科学奖（CTSA）资助的睡眠研究网络，该网络是美国最大，唯一的由联邦资助的睡眠科学网络，我们建议在六个儿科ICU中进行多中心的随机交叉试验，以比较一个睡眠和基于昼夜科学（SCS）的干预时间表与传统的时间表的安全性，其中包括24个小时或更多小时或更多时间。 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.此外，我们还将收集遗传材料，以将来对单个遗传易感性对睡眠剥夺和昼夜节律错位的不利影响进行测试，并将开始构建和测试数学建模工具，以促进实施优化的居民工作时间表。这项工作将提供有关将睡眠和昼夜科学应用于居住时间安排的有效性的明确数据，鉴于居民在为美国最恶心的患者提供护理方面的关键作用可能会产生重大的公共卫生影响。