24 Hour Intensivist Coverage in the Medical Intensive Care Unit

Critically Ill Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434823
• Other study ID #: UPenn 814063
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: September 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1609
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Discharge Home From Hospital	Patients who were discharged from the hospital to their homes	Assessed up to 12 months
Secondary	Daytime Intensivist Daily Sleep Duration	This will be the primary outcome of the Intensivist Sleep and Work sub-study.	Daily