iCOMPARE - DCC

 描述(由申请人提供)：在美国和其他国家，限制医学研究生教育值班时间的政策在过去十年中经历了重大修改，并成为一个中心辩论点。来自人类时间生物学和睡眠的证据表明，应该缩短轮班时间，因为疲劳会导致错误。然而，来自运筹学的证据支持更多的连续性，因为病人的移交也会导致错误，并可能降低培养独立临床医生所需的教育的有效性。来自这两个领域的证据令人信服，导致对于如何最好地配置疲劳管理、高质量患者护理和实习生教育的值班时间标准存在不确定性。2011年，医学研究生教育认证委员会(ACGME)对所有受训人员实施了更严格的值班时间标准。新的值班时间增加了研究生一年级(PGY1)实习生每天的工作时间不超过16小时。这一变化大大增加了患者交接的频率。因此，已经提出了替代工作时间表，将更长的轮班时间结合起来，以保持患者护理的连续性，并努力管理疲劳。我们建议对58个内科(IM)培训计划进行整群随机试验，以比较当前的值班时间标准(贯穿本提案的“Curr”)和更灵活的时间表(“Flex”)，该时间表基于当代对睡眠和患者安全的理解，并由三条规则定义：[1]每周工作不超过80小时；[2]通话频率不超过每3个晚上；[3]7天中休息1天-均超过4周。我们的主要假设针对的是患者的安全性：在Flex模式下30天的患者死亡率不会超过(不会低于 至)在货币下的死亡率。我们的第二个假设解决了教育、睡眠和疲劳：(A)与Curr的实习生相比，Flex的实习生在直接患者护理和教育方面花费的时间更多；(B)Flex的实习生平均每天获得的睡眠不少于(不低于)Curr的实习生。ICOMPARE(最优化患者安全和住院医生教育模型的个性化比较有效性)将提供严格的比较有效性数据，这些数据对于制定优化护理质量和未来医生能力的值班时间政策至关重要。此外，同样的两个时间表，Curr和新的Flex方案，正在进行的普通外科住院医生的第一次试验中进行了比较。主要在程序性和非程序性领域进行精心设计的单独审判的结合，将填补尚未满足的对高质量、可概括的证据的需求，以便为国家值班时间政策提供信息。

 DESCRIPTION (provided by applicant): In the US and other countries, policy limiting duty hours in graduate medical education has undergone significant revision in the last decade and become a central point of debate. Evidence from human chronobiology and sleep argues for shorter shifts because fatigue leads to errors. However, evidence from operations research argues for more continuity because patient handoffs also lead to errors and may reduce the effectiveness of education necessary to produce independent clinicians. The evidence from both fields is compelling, resulting in uncertainty regarding how to best configure duty hour standards for fatigue management, high quality patient care, and trainee education. In 2011, the Accreditation Council for Graduate Medical Education (ACGME) imposed more restrictive duty hour standards for all trainees. The new duty hours added that post-graduate year 1 (PGY1) trainees (interns) work no more than 16h duty periods in a day. This change greatly increased the frequency of patient handoffs. As a result, alternative work schedules have been proposed that combine longer shifts to maintain continuity of patient care with efforts to manage fatigue. We propose a cluster randomized trial of 58 Internal Medicine (IM) training programs to compare the current duty hour standards ("Curr" throughout this proposal) with a more flexible schedule ("Flex") that is grounded in contemporary understanding of sleep and patient safety and defined by three rules: [1] work no more than 80 hours per week; [2] call no more frequent than every 3rd night; [3] 1 day off in 7-all averaged over 4 weeks. Our primary hypothesis addresses patient safety: 30-day patient mortality under Flex will not exceed (will not be inferior to) mortality under Curr. Our secondary hypotheses address education and sleep and fatigue: (a) Interns in Flex will spend greater time in direct patient care and education compared to interns in Curr; (b) Average daily sleep obtained by interns in Flex will not be less than (will no be inferior to) that of interns in Curr. iCOMPARE (Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education) will provide the rigorous comparative effectiveness data essential to setting duty hour policies that optimize quality of care and the competency of our future physicians. Moreover, the same two schedules, Curr vs. the novel Flex scheme, are being compared in the ongoing FIRST trial in residents in general surgery. The combination of well-designed separate trials in both primarily procedural and non-procedural fields will fill the unmet need for a high-quality, generalizable body of evidence to inform national duty hour policy.