24 Hour Intensivist Coverage in the Medical Intensive Care Unit

NCT01434823 | Completed Results

• 1 other identifier: UPenn 814063
• Study Type: interventional
• Target: 1,609
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• MICU Mortality

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

• In-hospital Mortality

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

• Re-admission to the MICU Within 48 Hours

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

• Discharge Home From Hospital

  Assessed up to 12 months

• Daytime Intensivist Daily Sleep Duration

  Daily

Study Arms (2)

Intervention - nocturnal coverage

EXPERIMENTAL

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

Control - standard of care

NO INTERVENTION

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).

Interventions

Nocturnal coverage OTHER

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.

Intervention - nocturnal coverage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients, 18 years and older, who are admitted to the HUP MICU during the 12-month study period will be included in the study.

You may not qualify if:

• 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:

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 30985450 DERIVED

• 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.

  PMID: 23688301 DERIVED

MeSH Terms

Conditions

Critical Illness; Sleep Deprivation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Results Point of Contact

• Title: Dr. Meeta P. Kerlin
• Organization: University of Pennsylvania

meeta.prasad@uphs.upenn.edu

215.614.0627

Study Officials

• Scott D. Halpern, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 15, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 29, 2018
• Results First Posted: January 5, 2016

Record last verified: 2017-09

Locations

US (1)