Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT01434823
The Hospital of the University of Pennsylvania's Medical ICU (MICU) is implementing a model of 24-hour intensivist staffing in September 2011. Funds and resources are not available to cover the entire year, only certain weeks will be covered. The investigators propose a randomized clinical trial to study the comparative effectiveness of nocturnal intensivist staffing in the HUP MICU on patient outcomes. The investigators will be collecting and analyzing patient data of all patients admitted to the MICU from September 12, 2011, to September 11, 2012.
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All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Available evidence suggests that intensivist management of critically ill patients improves patient outcome, suggesting that greater intensivist coverage might be better still. However, the effects of 24-hour intensivist coverage in ICUs are unknown. In FY11, leadership of the Hospital of the University of Pennsylvania (HUP) decided to roll-out a program for partial night-coverage of the Medical Intensive Care Unit (MICU). In light of this natural experiment, the investigators propose to study the comparative effectiveness of nocturnal intensivist staffing in the HUP Medical Intensive Care Unit. To do so, the investigators propose a randomized clinical trial comparing the presence of a nocturnal intensivist (in-hospital call) to a traditional model of nocturnal coverage with an intensivist available by phone (home call) in the HUP MICU, with respect to patient-centered outcomes and resource utilization. The investigators will randomly assign seven consecutive days (Monday through Sunday) at a time to in-hospital or home call, in two-week blocks. The investigators will conduct primary analyses of all patients admitted during night hours and secondary analyses of various subgroups of patients admitted during night hours as well as all patients admitted during any time of day during the study period from September, 2011, to June, 2011.
A sub-study designed to measure sleep and work duration, sleepiness, and attention in Daytime Intensivists (faculty and fellows) during their medical ICU rotation will be conducted. The variables measured will be compared between periods with and without in-house nocturnal intensivist staffing. All fellows and faculty who rotate through the medical ICU during this study period, Jan 2012 to Dec 2012 will be approached for possible recruitment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For the Intensivist Sleep and Work sub-study looking at sleep, work hours, and attention of Daytime Intensivists during their MICU rotations:
Exclusion criteria
The investigators will randomize, by week, nocturnal coverage. During the intervention weeks, intensivists will be in the MICU from 7pm until 7am.
For the Intensivist Sleep and Work sub-study:
Measurements of Daytime Intensivist work hours, sleep, and attention will be measured with actigraphy, PVT, Sleep and Work Diaries, and Surveys. Results will be compared between periods with standard staffing to periods with overnight intensivist coverage.
Time frame: From time of admission in the MICU until time of discharge from the MICU - assessed up to 12 months
Time from ICU admission to discharge
Time frame: From time of admission to MICU until discharge from MICU - assessed up to 12 months
Mortality will be assessed during each patient's stay in the MICU from admission to discharge
Time frame: From time of admission to MICU to hospital discharge - assessed up to 12 months
Mortality will be assessed during each patient's stay in the hospital.
Time frame: From time of discharge from MICU, to re-admission to the MICU - assessed up to 12 months
The investigators will measure, in hours, the time spent from discharge from the MICU until a patient is re-admitted to the MICU during the same hospital stay.
Time frame: Assessed up to 12 months
Patients who were discharged from the hospital to their homes
Time frame: Daily
This will be the primary outcome of the Intensivist Sleep and Work sub-study.
University of Pennsylvania
Other
The Effects of 24-hour Intensivist Coverage in the Medical ICU
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