Clinical trial NCT01434823: 24 Hour Intensivist Coverage in the Medical Intensive Care Unit
Official title: The Effects of 24-hour Intensivist Coverage in the Medical ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill
Keywords: nocturnal staffing
intensivist staffing
intensivist coverage
ICU patient-centered outcomes
ICU resource utilization
patients admitted to the medical intensive care unit
Sleep Deprivation
Inattention
Work Hours
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2011-09-15
Enrollment: 1609
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients, 18 years and older, who are admitted to the HUP MICU during the 12-month study period will be included in the study.

Exclusion Criteria:

* No patients who meet these inclusion criteria will be excluded from this study.
* For patients admitted more than once to the MICU during the same hospitalization, we will include only their first admission to the MICU for all analyses.
* Subjects under 18 are very rarely seen at the HUP MICU because they are generally treated at the Children's Hospital of Philadelphia.
* In the rare event that a subject under the age of 18 receives care in the MICU his or her data will be excluded from this study.

For the Intensivist Sleep and Work sub-study looking at sleep, work hours, and attention of Daytime Intensivists during their MICU rotations:

* All University of Pennsylvania faculty members and fellows from the Division of Pulmonary, Allergy and Critical Care will be eligible for inclusion in the study if they rotate through the MICU during the study period (January, 2012 through December, 2012).

Exclusion Criteria:

* There are no exclusion criteria for this sub-study.

Primary outcomes:
measure: MICU Length of Stay
timeFrame: From time of admission in the MICU until time of discharge from the MICU - assessed up to 12 months
Secondary outcomes:
measure: MICU Mortality
timeFrame: From time of admission to MICU until discharge from MICU - assessed up to 12 months
measure: In-hospital Mortality
timeFrame: From time of admission to MICU to hospital discharge - assessed up to 12 months
measure: Re-admission to the MICU Within 48 Hours
timeFrame: From time of discharge from MICU, to re-admission to the MICU - assessed up to 12 months
measure: Discharge Home From Hospital
timeFrame: Assessed up to 12 months
measure: Daytime Intensivist Daily Sleep Duration
timeFrame: Daily
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Scott D. Halpern, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bakhru RN, Basner M, Kerlin MP, Halpern SD, Hansen-Flaschen J, Rosen IM, Dinges DF, Schweickert WD. Sleep and Work in ICU Physicians During a Randomized Trial of Nighttime Intensivist Staffing. Crit Care Med. 2019 Jul;47(7):894-902. doi: 10.1097/CCM.0000000000003773.
citation: Kerlin MP, Small DS, Cooney E, Fuchs BD, Bellini LM, Mikkelsen ME, Schweickert WD, Bakhru RN, Gabler NB, Harhay MO, Hansen-Flaschen J, Halpern SD. A randomized trial of nighttime physician staffing in an intensive care unit. N Engl J Med. 2013 Jun 6;368(23):2201-9. doi: 10.1056/NEJMoa1302854. Epub 2013 May 20.