24 Hour Intensivist Coverage in the Medical Intensive Care Unit

The Effects of 24-hour Intensivist Coverage in the Medical ICU

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.

Study Overview

• Status: Completed
• Conditions: Critically Ill
• Intervention / Treatment: Other: Nocturnal coverage

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.

• Study Type: Interventional
• Enrollment (Actual): 1609
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MICU Length of Stay	Time from ICU admission to discharge	From time of admission in the MICU until time of discharge from the MICU - assessed up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MICU Mortality	Mortality will be assessed during each patient's stay in the MICU from admission to discharge	From time of admission to MICU until discharge from MICU - assessed up to 12 months
In-hospital Mortality	Mortality will be assessed during each patient's stay in the hospital.	From time of admission to MICU to hospital discharge - assessed up to 12 months
Re-admission to the MICU Within 48 Hours	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.	From time of discharge from MICU, to re-admission to the MICU - assessed up to 12 months
Discharge Home From Hospital	Patients who were discharged from the hospital to their homes	Assessed up to 12 months
Daytime Intensivist Daily Sleep Duration	This will be the primary outcome of the Intensivist Sleep and Work sub-study.	Daily

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Scott D. Halpern, MD, PhD, University of Pennsylvania

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 30, 2011
• First Submitted That Met QC Criteria: September 14, 2011
• First Posted (Estimate): September 15, 2011

Study Record Updates

• Last Update Posted (Actual): May 29, 2018
• Last Update Submitted That Met QC Criteria: September 20, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Sleep Deprivation; Inattention; ICU resource utilization; nocturnal staffing; intensivist staffing; intensivist coverage; ICU patient-centered outcomes; patients admitted to the medical intensive care unit; Work Hours
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: UPenn 814063