Trial Outcomes & Findings for 24 Hour Intensivist Coverage in the Medical Intensive Care Unit (NCT NCT01434823)

NCT ID: NCT01434823

Last Updated: 2018-05-29

Results Overview

Time from ICU admission to discharge

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1609 participants
• Primary outcome timeframe: From time of admission in the MICU until time of discharge from the MICU - assessed up to 12 months
• Results posted on: 2018-05-29

Participant Flow

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.

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.

Participant milestones

Measure	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.
Overall Study STARTED	824	785
Overall Study COMPLETED	820	778
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Measure	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.
Overall Study Incomplete data in medical record	4	7

Baseline Characteristics

24 Hour Intensivist Coverage in the Medical Intensive Care Unit

Baseline characteristics by cohort

Measure	Intervention - Nocturnal Coverage n=820 Participants 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 n=778 Participants 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 n=1598 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 17 • n=5 Participants	59 years STANDARD_DEVIATION 16 • n=7 Participants	58 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	366 Participants n=5 Participants	356 Participants n=7 Participants	722 Participants n=5 Participants
Sex: Female, Male Male	454 Participants n=5 Participants	422 Participants n=7 Participants	876 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	328 Participants n=5 Participants	315 Participants n=7 Participants	643 Participants n=5 Participants
Race (NIH/OMB) White	417 Participants n=5 Participants	387 Participants n=7 Participants	804 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	70 Participants n=5 Participants	65 Participants n=7 Participants	135 Participants n=5 Participants
Region of Enrollment United States	820 participants n=5 Participants	778 participants n=7 Participants	1598 participants n=5 Participants

PRIMARY outcome

Timeframe: From time of admission in the MICU until time of discharge from the MICU - assessed up to 12 months

Time from ICU admission to discharge

Outcome measures

Measure	Intervention - Nocturnal Coverage n=820 Participants 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 n=778 Participants 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).
MICU Length of Stay	52.8 hours Interval 29.3 to 116.1	52.6 hours Interval 28.2 to 110.5

SECONDARY outcome

Timeframe: From time of admission to MICU until discharge from MICU - assessed up to 12 months

Mortality will be assessed during each patient's stay in the MICU from admission to discharge

Outcome measures

Measure	Intervention - Nocturnal Coverage n=820 Participants 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 n=778 Participants 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).
MICU Mortality	154 participants	139 participants

SECONDARY outcome

Timeframe: From time of admission to MICU to hospital discharge - assessed up to 12 months

Mortality will be assessed during each patient's stay in the hospital.

Outcome measures

Measure	Intervention - Nocturnal Coverage n=820 Participants 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 n=778 Participants 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).
In-hospital Mortality	203 participants	177 participants

SECONDARY outcome

Timeframe: From time of discharge from MICU, to re-admission to the MICU - assessed up to 12 months

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.

Outcome measures

Measure	Intervention - Nocturnal Coverage n=820 Participants 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 n=778 Participants 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).
Re-admission to the MICU Within 48 Hours	32 participants	21 participants

SECONDARY outcome

Timeframe: Assessed up to 12 months

Patients who were discharged from the hospital to their homes

Outcome measures

Measure	Intervention - Nocturnal Coverage n=820 Participants 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 n=778 Participants 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).
Discharge Home From Hospital	317 participants	314 participants

SECONDARY outcome

Timeframe: Daily

This will be the primary outcome of the Intensivist Sleep and Work sub-study.

Outcome measures

Measure	Intervention - Nocturnal Coverage n=20 Participants 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 n=20 Participants 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).
Daytime Intensivist Daily Sleep Duration	6.69 hours Standard Deviation 0.13	6.37 hours Standard Deviation 0.16

Adverse Events

Intervention - Nocturnal Coverage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control - Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Meeta P. Kerlin

University of Pennsylvania

Phone: 215.614.0627

Email: meeta.prasad@uphs.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place