Critically Ill
Conditions
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
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.
Detailed 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.
Interventions
OTHERNocturnal 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.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MICU Length of Stay | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MICU Mortality | 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 |
| In-hospital Mortality | 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. |
| 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 | 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. |
| Discharge Home From Hospital | Assessed up to 12 months | Patients who were discharged from the hospital to their homes |
| Daytime Intensivist Daily Sleep Duration | Daily | This will be the primary outcome of the Intensivist Sleep and Work sub-study. |
Countries
United States
Participant flow
Recruitment details
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
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 820 |
| 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). | 778 |
| Total | 1,598 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incomplete data in medical record | 4 | 7 |
Baseline characteristics
| Characteristic | Intervention - Nocturnal Coverage | Total | Control - Standard of Care |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 17 | 58 years STANDARD_DEVIATION 17 | 59 years STANDARD_DEVIATION 16 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 16 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 328 Participants | 643 Participants | 315 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 70 Participants | 135 Participants | 65 Participants |
| Race (NIH/OMB) White | 417 Participants | 804 Participants | 387 Participants |
| Region of Enrollment United States | 820 participants | 1598 participants | 778 participants |
| Sex: Female, Male Female | 366 Participants | 722 Participants | 356 Participants |
| Sex: Female, Male Male | 454 Participants | 876 Participants | 422 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 820 | 0 / 778 |
| serious Total, serious adverse events | 0 / 820 | 0 / 778 |
Outcome results
Primary
MICU Length of Stay
Time from ICU admission to discharge
Time frame: From time of admission in the MICU until time of discharge from the MICU - assessed up to 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention - Nocturnal Coverage | MICU Length of Stay | 52.8 hours |
| Control - Standard of Care | MICU Length of Stay | 52.6 hours |
Secondary
Daytime Intensivist Daily Sleep Duration
This will be the primary outcome of the Intensivist Sleep and Work sub-study.
Time frame: Daily
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention - Nocturnal Coverage | Daytime Intensivist Daily Sleep Duration | 6.69 hours | Standard Deviation 0.13 |
| Control - Standard of Care | Daytime Intensivist Daily Sleep Duration | 6.37 hours | Standard Deviation 0.16 |
Secondary
Discharge Home From Hospital
Patients who were discharged from the hospital to their homes
Time frame: Assessed up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention - Nocturnal Coverage | Discharge Home From Hospital | 317 participants |
| Control - Standard of Care | Discharge Home From Hospital | 314 participants |
Secondary
In-hospital Mortality
Mortality will be assessed during each patient's stay in the hospital.
Time frame: From time of admission to MICU to hospital discharge - assessed up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention - Nocturnal Coverage | In-hospital Mortality | 203 participants |
| Control - Standard of Care | In-hospital Mortality | 177 participants |
Secondary
MICU Mortality
Mortality will be assessed during each patient's stay in the MICU from admission to discharge
Time frame: From time of admission to MICU until discharge from MICU - assessed up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention - Nocturnal Coverage | MICU Mortality | 154 participants |
| Control - Standard of Care | MICU Mortality | 139 participants |
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.
Time frame: From time of discharge from MICU, to re-admission to the MICU - assessed up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention - Nocturnal Coverage | Re-admission to the MICU Within 48 Hours | 32 participants |
| Control - Standard of Care | Re-admission to the MICU Within 48 Hours | 21 participants |