24 Hour Intensivist Coverage in the Medical Intensive Care Unit

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Scott Halpern, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01434823
First received: August 30, 2011
Last updated: November 30, 2015
Last verified: November 2015
Results First Received: March 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Critically Ill
Intervention: Other: Nocturnal coverage

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We enrolled all patients admitted to the medical ICU (MICU) service at the Hospital of the University of Pennsylvania for one year from September 12, 2011, to September 11, 2012. In-hospital follow-up was conducted for an additional 90 days.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusions included patients who were readmitted to the ICU within the same hospitalization (we included their first ICU admission), patients who were admitted during the holiday block (no nighttime coverage), and patients who had ICU stays so brief they were either were not exposed to nighttime hours or ineligible for APACHE score calculation.

Reporting Groups
  Description
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.

Randomization was blocked such that 1 week of a 2-week attending block of service was randomized to nocturnal coverage. We also calculated the proportion of "covered nights" for each patient's ICU stay in secondary analyses.

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).

Randomization was blocked such that 1 week of a 2-week attending block of service was randomized to nocturnal coverage. We also calculated the proportion of "covered nights" for each patient's ICU stay.


Participant Flow:   Overall Study
    Intervention - Nocturnal Coverage     Control - Standard of Care  
STARTED     824     785  
COMPLETED     820     778  
NOT COMPLETED     4     7  
Incomplete data in medical record                 4                 7  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
824 patients were randomized to the intervention group, 4 of which have been excluded from analyses to due incomplete data (n=820), 785 were randomized to the control group, 7 of which have been excluded from analyses due to incomplete data (n=778).

Reporting Groups
  Description
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.
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).
Total Total of all reporting groups

Baseline Measures
    Intervention - Nocturnal Coverage     Control - Standard of Care     Total  
Number of Participants  
[units: participants]
  820     778     1598  
Age  
[units: years]
Mean (Standard Deviation)
  58  (17)     59  (16)     58  (17)  
Gender  
[units: participants]
     
Female     366     356     722  
Male     454     422     876  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     5     11     16  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     328     315     643  
White     417     387     804  
More than one race     0     0     0  
Unknown or Not Reported     70     65     135  
Region of Enrollment  
[units: participants]
     
United States     820     778     1598  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   MICU Mortality   [ Time Frame: From time of admission to MICU until discharge from MICU - assessed up to 12 months ]

3.  Secondary:   In-hospital Mortality   [ Time Frame: From time of admission to MICU to hospital discharge - assessed up to 12 months ]

4.  Secondary:   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 ]

5.  Secondary:   Discharge Home From Hospital   [ Time Frame: Assessed up to 12 months ]

6.  Secondary:   Daytime Intensivist Daily Sleep Duration   [ Time Frame: Daily ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Daytime Intensivist Sleep Efficiency   [ Time Frame: Daily ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Number of Interruptions Per Night for Daytime Intensivists   [ Time Frame: Daily ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Maximal Uninterrupted Sleep Duration for Daytime Intensivists   [ Time Frame: Daily ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Reaction Time of Daytime Intensivists (on Vigilance Testing)   [ Time Frame: Daily on Weekdays ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Daytime Intensivist Lapses in Attention (on Vigilance Testing)   [ Time Frame: Daily on Weekdays ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Daytime Intensivist False Starts (on Vigilance Testing)   [ Time Frame: Daily on Weekdays ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Daytime Intensivist Hours Worked Per Week (Without Home Call)   [ Time Frame: Weekly ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

14.  Secondary:   Daytime Intensivist Hours Worked Per Week (Inclusive of Home Call)   [ Time Frame: Weekly ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

15.  Secondary:   Total Number of Calls Per Night for Daytime Intensivist   [ Time Frame: Daily ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

16.  Secondary:   Duration of Rounds for Daytime Intensivist   [ Time Frame: Daily ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Meeta P. Kerlin
Organization: University of Pennsylvania
phone: 215.614.0627
e-mail: meeta.prasad@uphs.upenn.edu


No publications provided by University of Pennsylvania

Publications automatically indexed to this study:

Responsible Party: Scott Halpern, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01434823     History of Changes
Other Study ID Numbers: UPenn 814063
Study First Received: August 30, 2011
Results First Received: March 1, 2013
Last Updated: November 30, 2015
Health Authority: United States: Institutional Review Board