Christopher S Parshuram1, Andre C K B Amaral2, Niall D Ferguson2, G Ross Baker2, Edward E Etchells2, Virginia Flintoft2, John Granton2, Lorelei Lingard2, Haresh Kirpalani2, Sangeeta Mehta2, Harvey Moldofsky2, Damon C Scales2, Thomas E Stewart2, Andrew R Willan2, Jan O Friedrich2. 1. Department of Critical Care Medicine (Parshuram) and The Center for Safety Research at Child Health Evaluative Sciences (Parshuram, Willan), The Hospital for Sick Children, Toronto, Ont.; Interdepartmental Division of Critical Care Medicine (Parshuram, Amaral, Ferguson, Granton, Mehta, Scales, Friedrich,), Institute for Health Policy, Management and Evaluation (Baker, Flintoft), Department of Medicine (Etchells, Granton, Stewart), Department of Anaesthesia (Stewart) and Dalla Lana School of Public Health (Willan), University of Toronto, Toronto, Ont.; Department of Critical Care (Friedrich) and Li Ka Shing Knowledge Institute (Friedrich), St. Michael's Hospital, Toronto, Ont.; Sunnybrook Research Institute (Amaral, Scales), Department of Critical Care Medicine (Amaral, Scales) and Division of General Internal Medicine (Etchells), Sunnybrook Health Sciences Centre, Toronto, Ont.; Critical Care Medicine (Granton), University Health Network, Toronto, Ont.; Centre for Education Research and Innovation (Lingard) and Department of Medicine and Dentistry (Lingard), Western University, London, Ont.; Perelman School of Medicine (Kirpalani), University of Pennsylvania, Philadelphia, Pa.; Neonatology (Kirpalani), The Children's Hospital of Philadelphia, Philadelphia, Pa.; Department of Medicine, Division of Respirology and Critical Care Program (Ferguson, Mehta), Mount Sinai Hospital and University Health Network, Toronto, Ont.; Department of Medicine, (Mehta) Mount Sinai Hospital, Toronto, Ont.; Sleep Disorders Clinic of the Centre for Sleep and Chronobiology (Moldofsky), Toronto, Ont.; Department of Clinical Epidemiology and Biostatistics (Willan), McMaster University, Hamilton, Ont.; Research Institute (Ferguson), Toronto General Hospital, Toronto, Ont. christopher.parshuram@sickkids.ca. 2. Department of Critical Care Medicine (Parshuram) and The Center for Safety Research at Child Health Evaluative Sciences (Parshuram, Willan), The Hospital for Sick Children, Toronto, Ont.; Interdepartmental Division of Critical Care Medicine (Parshuram, Amaral, Ferguson, Granton, Mehta, Scales, Friedrich,), Institute for Health Policy, Management and Evaluation (Baker, Flintoft), Department of Medicine (Etchells, Granton, Stewart), Department of Anaesthesia (Stewart) and Dalla Lana School of Public Health (Willan), University of Toronto, Toronto, Ont.; Department of Critical Care (Friedrich) and Li Ka Shing Knowledge Institute (Friedrich), St. Michael's Hospital, Toronto, Ont.; Sunnybrook Research Institute (Amaral, Scales), Department of Critical Care Medicine (Amaral, Scales) and Division of General Internal Medicine (Etchells), Sunnybrook Health Sciences Centre, Toronto, Ont.; Critical Care Medicine (Granton), University Health Network, Toronto, Ont.; Centre for Education Research and Innovation (Lingard) and Department of Medicine and Dentistry (Lingard), Western University, London, Ont.; Perelman School of Medicine (Kirpalani), University of Pennsylvania, Philadelphia, Pa.; Neonatology (Kirpalani), The Children's Hospital of Philadelphia, Philadelphia, Pa.; Department of Medicine, Division of Respirology and Critical Care Program (Ferguson, Mehta), Mount Sinai Hospital and University Health Network, Toronto, Ont.; Department of Medicine, (Mehta) Mount Sinai Hospital, Toronto, Ont.; Sleep Disorders Clinic of the Centre for Sleep and Chronobiology (Moldofsky), Toronto, Ont.; Department of Clinical Epidemiology and Biostatistics (Willan), McMaster University, Hamilton, Ont.; Research Institute (Ferguson), Toronto General Hospital, Toronto, Ont.
Abstract
BACKGROUND: Shorter resident duty periods are increasingly mandated to improve patient safety and physician well-being. However, increases in continuity-related errors may counteract the purported benefits of reducing fatigue. We evaluated the effects of 3 resident schedules in the intensive care unit (ICU) on patient safety, resident well-being and continuity of care. METHODS:Residents in 2 university-affiliated ICUs were randomly assigned (in 2-month rotation-blocks from January to June 2009) to in-house overnight schedules of 24, 16 or 12 hours. The primary patient outcome was adverse events. The primary resident outcome was sleepiness, measured by the 7-point Stanford Sleepiness Scale. Secondary outcomes were patient deaths, preventable adverse events, and residents' physical symptoms and burnout. Continuity of care and perceptions of ICU staff were also assessed. RESULTS: We evaluated 47 (96%) of 49 residents, all 971 admissions, 5894 patient-days and 452 staff surveys. We found no effect of schedule (24-, 16- or 12-h shifts) on adverse events (81.3, 76.3 and 78.2 events per 1000 patient-days, respectively; p = 0.7) or on residents' sleepiness in the daytime (mean rating 2.33, 2.61 and 2.30, respectively; p = 0.3) or at night (mean rating 3.06, 2.73 and 2.42, respectively; p = 0.2). Seven of 8 preventable adverse events occurred with the 12-hour schedule (p = 0.1). Mortality rates were similar for the 3 schedules. Residents' somatic symptoms were more severe and more frequent with the 24-hour schedule (p = 0.04); however, burnout was similar across the groups. ICU staff rated residents' knowledge and decision-making worst with the 16-hour schedule. INTERPRETATION: Our findings do not support the purported advantages of shorter duty schedules. They also highlight the trade-offs between residents' symptoms and multiple secondary measures of patient safety. Further delineation of this emerging signal is required before widespread system change. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT00679809.
RCT Entities:
BACKGROUND: Shorter resident duty periods are increasingly mandated to improve patient safety and physician well-being. However, increases in continuity-related errors may counteract the purported benefits of reducing fatigue. We evaluated the effects of 3 resident schedules in the intensive care unit (ICU) on patient safety, resident well-being and continuity of care. METHODS: Residents in 2 university-affiliated ICUs were randomly assigned (in 2-month rotation-blocks from January to June 2009) to in-house overnight schedules of 24, 16 or 12 hours. The primary patient outcome was adverse events. The primary resident outcome was sleepiness, measured by the 7-point Stanford Sleepiness Scale. Secondary outcomes were patient deaths, preventable adverse events, and residents' physical symptoms and burnout. Continuity of care and perceptions of ICU staff were also assessed. RESULTS: We evaluated 47 (96%) of 49 residents, all 971 admissions, 5894 patient-days and 452 staff surveys. We found no effect of schedule (24-, 16- or 12-h shifts) on adverse events (81.3, 76.3 and 78.2 events per 1000 patient-days, respectively; p = 0.7) or on residents' sleepiness in the daytime (mean rating 2.33, 2.61 and 2.30, respectively; p = 0.3) or at night (mean rating 3.06, 2.73 and 2.42, respectively; p = 0.2). Seven of 8 preventable adverse events occurred with the 12-hour schedule (p = 0.1). Mortality rates were similar for the 3 schedules. Residents' somatic symptoms were more severe and more frequent with the 24-hour schedule (p = 0.04); however, burnout was similar across the groups. ICU staff rated residents' knowledge and decision-making worst with the 16-hour schedule. INTERPRETATION: Our findings do not support the purported advantages of shorter duty schedules. They also highlight the trade-offs between residents' symptoms and multiple secondary measures of patient safety. Further delineation of this emerging signal is required before widespread system change. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT00679809.
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