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24 Hour Intensivist Coverage in the Medical Intensive Care Unit

Primary Purpose

Critically Ill

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nocturnal coverage
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Critically Ill focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention - nocturnal coverage

Control - standard of care

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

MICU Length of Stay
Time from ICU admission to discharge

Secondary Outcome Measures

MICU Mortality
Mortality will be assessed during each patient's stay in the MICU from admission to discharge
In-hospital Mortality
Mortality will be assessed during each patient's stay in the hospital.
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.
Discharge Home From Hospital
Patients who were discharged from the hospital to their homes
Daytime Intensivist Daily Sleep Duration
This will be the primary outcome of the Intensivist Sleep and Work sub-study.

Full Information

First Posted
August 30, 2011
Last Updated
September 20, 2017
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01434823
Brief Title
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1609 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention - nocturnal coverage
Arm Type
Experimental
Arm Description
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.
Arm Title
Control - standard of care
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Nocturnal coverage
Intervention Description
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.
Primary Outcome Measure Information:
Title
MICU Length of Stay
Description
Time from ICU admission to discharge
Time Frame
From time of admission in the MICU until time of discharge from the MICU - assessed up to 12 months
Secondary Outcome Measure Information:
Title
MICU Mortality
Description
Mortality will be assessed during each patient's stay in the MICU from admission to discharge
Time Frame
From time of admission to MICU until discharge from MICU - assessed up to 12 months
Title
In-hospital Mortality
Description
Mortality will be assessed during each patient's stay in the hospital.
Time Frame
From time of admission to MICU to hospital discharge - assessed up to 12 months
Title
Re-admission to the MICU Within 48 Hours
Description
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
From time of discharge from MICU, to re-admission to the MICU - assessed up to 12 months
Title
Discharge Home From Hospital
Description
Patients who were discharged from the hospital to their homes
Time Frame
Assessed up to 12 months
Title
Daytime Intensivist Daily Sleep Duration
Description
This will be the primary outcome of the Intensivist Sleep and Work sub-study.
Time Frame
Daily

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott D. Halpern, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30985450
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.
Results Reference
derived
PubMed Identifier
23688301
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.
Results Reference
derived

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24 Hour Intensivist Coverage in the Medical Intensive Care Unit

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