iCOMPARE - DCC

 描述（由申请人提供）：在美国和其他国家，在过去十年中，限制研究生医学教育工作时间的政策经历了重大修订，并成为辩论的中心点。来自人类时间生物学和睡眠的证据支持更短的轮班，因为疲劳会导致错误。然而，来自运筹学的证据表明需要更多的连续性，因为患者的失误也会导致错误，并可能降低培养独立临床医生所必需的教育的有效性。来自这两个领域的证据是令人信服的，导致不确定性，如何最好地配置值班时间标准的疲劳管理，高质量的病人护理，和学员教育。2011年，研究生医学教育认证理事会（ACGME）对所有学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（PGY 1）学员（实习生）每天工作不超过16小时的值班时间。这一变化大大增加了患者的流产频率。因此，有人提出了替代工作时间表，将联合收割机更长的轮班时间与管理疲劳的努力结合起来，以保持病人护理的连续性。我们提出了一个58个内科（IM）培训计划的集群随机试验，以比较目前的值班时间标准（在本提案中称为“Curr”），具有更灵活的时间表（“Flex”），该时间表基于对睡眠和患者安全的当代理解，并由三条规则定义：[1]每周工作不超过80小时; [2]通话频率不超过每三个晚上;[3] 7天中有1天休息-平均超过4周。我们的主要假设涉及患者安全性：Flex下的30天患者死亡率不会超过（不会劣效于 至）低于Curr的死亡率。我们的次要假设涉及教育、睡眠和疲劳：（a）与Curr的实习生相比，Flex的实习生将花费更多的时间进行直接患者护理和教育;（B）Flex的实习生获得的平均每日睡眠不会少于（不会劣于）Curr的实习生。iCOMPARE（优化患者安全和住院医师教育的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我们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与新的Flex计划，正在进行的第一次试验中进行比较的居民在普通外科。在主要是程序性和非程序性领域进行精心设计的单独审判，将满足为国家值班时间政策提供高质量、可推广的证据这一尚未得到满足的需求。

 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.