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iCOMPARE - DCC

基本信息

批准号：
9306926
负责人：
James A Tonascia
金额：
$ 75.08万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-08-12 至 2019-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9306926
关键词：
Accreditation Address Affect Americas Behavioral Caring Chronobiology Clinical Cluster randomized trial Competence Complication Continuity of Patient Care Country Data Drowsiness Education Educational process of instructing Effectiveness Ensure Faculty Fatigue Frequencies Future Goals Grant Hour Human Inferior Internal Medicine Internships Lead Length of Stay Measures Medical Errors Medicare Modeling Monitor Operations Research Operative Surgical Procedures Ownership Patient Care Patient Education Patients Perception Physicians Policies Polysomnography Post Graduate Year Quality of Care Randomized Randomized Controlled Trials Reporting Research Safety Schedule Scheme Sleep Standardization Structure Supervision System Teaching Hospitals Testing Time Training Training Programs Uncertainty United States United States Agency for Healthcare Research and Quality Work actigraphy alertness burnout comparative effectiveness cost design diaries direct patient care experience flexibility graduate medical education hospital readmission interest mortality novel patient safety payment primary outcome programs public health relevance satisfaction

项目摘要

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.