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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| In-hospital Mortality |
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Inclusion Criteria:
Exclusion Criteria:
For the Intensivist Sleep and Work sub-study looking at sleep, work hours, and attention of Daytime Intensivists during their MICU rotations:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott D. Halpern, MD, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30985450 | Derived | 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. | |
| 23688301 | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control - Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MICU Length of Stay | Time from ICU admission to discharge | Posted | Median | Inter-Quartile Range | hours | From time of admission in the MICU until time of discharge from the MICU - assessed up to 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Meeta P. Kerlin | University of Pennsylvania | 215.614.0627 | meeta.prasad@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020920 | Dyssomnias |
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|
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 |
| 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 |
| Discharge Home From Hospital | Patients who were discharged from the hospital to their homes | Assessed up to 12 months |
| Daytime Intensivist Daily Sleep Duration | This will be the primary outcome of the Intensivist Sleep and Work sub-study. | Daily |
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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | MICU Mortality | Mortality will be assessed during each patient's stay in the MICU from admission to discharge | Posted | Number | participants | 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. | Posted | Number | participants | 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. | Posted | Number | participants | 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 | Posted | Number | participants | 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. | Posted | Mean | Standard Deviation | hours | Daily |
|
|
|
| 0 |
| 820 |
| 0 |
| 820 |
| EG001 | 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). | 0 | 778 | 0 | 778 |
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| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001523 | Mental Disorders |