24 Hour Intensivist Coverage in the Medical Intensive Care Unit
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|ClinicalTrials.gov Identifier: NCT01434823|
Recruitment Status : Completed
First Posted : September 15, 2011
Results First Posted : January 5, 2016
Last Update Posted : May 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Critically Ill||Other: Nocturnal coverage||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1609 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||The Effects of 24-hour Intensivist Coverage in the Medical ICU|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Experimental: Intervention - nocturnal coverage
Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
Other: Nocturnal coverage
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.
No Intervention: Control - standard of care
The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
- MICU Length of Stay [ 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
- MICU Mortality [ 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
- In-hospital Mortality [ 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.
- Re-admission to the MICU Within 48 Hours [ 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.
- Discharge Home From Hospital [ Time Frame: Assessed up to 12 months ]Patients who were discharged from the hospital to their homes
- Daytime Intensivist Daily Sleep Duration [ Time Frame: Daily ]This will be the primary outcome of the Intensivist Sleep and Work sub-study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434823
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Scott D. Halpern, MD, PhD||University of Pennsylvania|