24 Hour Intensivist Coverage in the Medical Intensive Care Unit

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Pennsylvania.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Scott Halpern, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01434823
First received: August 30, 2011
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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, 2011, to June, 2011.


Condition Intervention
Critically Ill
Other: Nocturnal coverage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Effects of 24-hour Intensivist Coverage in the Medical ICU

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • MICU length of stay [ Time Frame: From time of admission in the MICU until time of discharge from the MICU - assessed up to 10 months ] [ Designated as safety issue: No ]
    This is the length of time that a patient spends in the MICU. It could be anywhere from hours to months.


Secondary Outcome Measures:
  • MICU Mortality [ Time Frame: From time of admission to MICU until discharge from MICU - assessed up to 10 months ] [ Designated as safety issue: No ]
    Mortality will be assessed during each patient's stay in the MICU. A stay in the MICU could be hours to months.

  • In-hospital mortality [ Time Frame: From time of admission to MICU to hospital discharge - assessed up to 10 months ] [ Designated as safety issue: No ]
    Mortality will be assessed during each patient's stay in the hospital stay. A stay in the hospital could be hours to months.

  • Procedure events, success, and complications [ Time Frame: From time of admission to MICU to discharge from the MICU - assessed up to 10 months ] [ Designated as safety issue: Yes ]
    During a patient's stay in the MICU a number of procedures may be performed. Procedures, their success, and any subsequent complications will be assessed over their length of stay in the MICU which could be hours to months.

  • Need for re-intubation [ Time Frame: From time of intubation to extubation to re-intubation during stay in MICU - assessed up to 10 months ] [ Designated as safety issue: No ]
    Time of intubation to extubation will be measured, in hours, over the course of patient's stay in the MICU. If a patient is extubated and needs to be re-intubated, that will be measured, in hours, as well.

  • Hospital length of stay [ Time Frame: From time of hospital admission to time of hospital discharge - assessed up to 10 months ] [ Designated as safety issue: No ]
    This is the length of time that a patient spends in the hospital. It could be anywhere from hours to months.

  • Re-admission to the MICU [ Time Frame: From time of discharge from MICU, to re-admission to the MICU - assessed up to 10 months ] [ Designated as safety issue: No ]
    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.

  • Frequency and volume of blood transfusions [ Time Frame: From time of admission to the MICU to the time of discharge from the MICU - assessed up to 10 months ] [ Designated as safety issue: Yes ]
    The investigators will assess how often and how much blood is transfused over the course of a patient's stay in the MICU. A stay in the MICU could be hours to months.

  • Daytime Intensivist Daily Sleep Duration [ Time Frame: Daily ] [ Designated as safety issue: No ]
    This will be the primary outcome of the Intensivist Sleep and Work sub-study.

  • Daytime Intensivist Sleep Efficiency [ Time Frame: Daily ] [ Designated as safety issue: No ]
    This will be a secondary outcome of the Intensivist Sleep and Work sub-study.

  • Number of interruptions per night for Daytime Intensivists [ Time Frame: Daily ] [ Designated as safety issue: No ]
    This will be a secondary outcome of the Intensivist Sleep and Work sub-study.

  • Maximal Uninterrupted Sleep Duration for Daytime Intensivists [ Time Frame: Daily ] [ Designated as safety issue: No ]
    This will be a secondary outcome of the Intensivist Sleep and Work sub-study.

  • Reaction Time of Daytime Intensivists (on Vigilance Testing) [ Time Frame: Daily on Weekdays ] [ Designated as safety issue: No ]
    This will be a secondary outcome of the Intensivist Sleep and Work sub-study.

  • Daytime Intensivist Lapses in Attention (on Vigilance Testing) [ Time Frame: Daily on Weekdays ] [ Designated as safety issue: No ]
    This will be a secondary outcome of the Intensivist Sleep and Work sub-study.

  • Daytime Intensivist False starts (on Vigilance Testing) [ Time Frame: Daily on Weekdays ] [ Designated as safety issue: No ]
    This will be a secondary outcome of the Intensivist Sleep and Work sub-study.

  • Daytime Intensivist Hours worked per week (without home call) [ Time Frame: Weekly ] [ Designated as safety issue: No ]
    This will be a secondary outcome of the Intensivist Sleep and Work sub-study.

  • Daytime Intensivist Hours worked per week (Inclusive of home call) [ Time Frame: Weekly ] [ Designated as safety issue: No ]
    This will be a secondary outcome of the Intensivist Sleep and Work sub-study.

  • Total Number of Calls per night for Daytime Intensivist [ Time Frame: Daily ] [ Designated as safety issue: No ]
    This will be a secondary outcome of the Intensivist Sleep and Work sub-study.

  • Duration of Rounds for Daytime Intensivist [ Time Frame: Daily ] [ Designated as safety issue: No ]
    This will be a secondary outcome of the Intensivist Sleep and Work sub-study.


Estimated Enrollment: 1300
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients, 18 years and older, who are admitted to the HUP MICU during the 10-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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434823

Contacts
Contact: Elizabeth Cooney, MPH 215.573.9461 elcooney@upenn.edu
Contact: Meeta Prasad, MD 215.614.0627 meeta.prasad@uphs.upenn.edu

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Elizabeth Cooney    215-573-9461      
Principal Investigator: Scott D. Halpern, MD, PhD         
Sub-Investigator: Meeta Prasad, MD, MSCE         
Sub-Investigator: William Schweickert, MD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Scott D. Halpern, MD, PhD University of Pennsylvania
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Scott Halpern, Assistant Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01434823     History of Changes
Other Study ID Numbers: UPenn 814063
Study First Received: August 30, 2011
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014