Clinical trial NCT04176094: Intensive Care Unit Resident Scheduling Trial
Official title: Intensive Care Unit Resident Scheduling Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patient Safety
Well-being
Education
Keywords: health service and systems research
population health
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
First posted: 2019-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A cluster-randomized crossover trial will compare 16h vs. 24h overnight schedules for residents completing an ICU rotation.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Many patients, doctors and others worry that tired doctors provide worse patient care, may not learn well and become burnt-out. In response to these concerns, some countries changed their laws to limit work-hours for doctors in training ('residents').

In Canada, most residents work six or seven 24-30h shifts each month. A recent Canadian report ordered by Health Canada said that making good decisions about resident work-hour rules was "significantly limited by quality evidence, especially evidence directly attributable to the Canadian context." Creating this evidence is the main goal of this research.

The pilot study in 2 intensive care units(ICU) found that shorter shifts may be worse for patients, and for residents were more tiring than expected but improved wellbeing. Learning was not assessed. Previous studies on resident work-hours report similar findings: conflicting effects for patients, benefits for resident wellbeing, inconsistent and under-studied effects on learning. Overall, these results are not conclusive and confirm the need for a larger study.

The current study will provide high-quality Canadian evidence. The investigators will compare two common ICU schedules used in Canada: resident shifts of 16h and 24h. ICU patients are very sick, there is little margin for error: they need doctors who know them well and are thinking clearly.

The effects of each schedule on patients and residents will be measured. For patients, mortality rates and harm caused by care in ICU will be studied. For resident education, their learning about managing common illnesses in ICU, to do basic ICU procedures, and communicate with families will be studied. For resident wellbeing measures will include sleepiness, other fatigue symptoms, and burnout.

Investigators will study both resident and patient outcomes so that Canadians can understand trade-offs linked to changing schedules. With this knowledge, Canadians can expect safer care for today's patients and better-trained doctors for the patients of tomorrow.

Detailed description: Background: Strategies to manage residents' fatigue must balance patient safety, resident education and resident wellbeing. The trade-offs among these are not fully understood. A Canadian cluster-randomized clinical trial will provide urgently needed evidence to inform resident scheduling practice and policy.

Previous work questions assumptions used to justify duty hour reduction. The investigators found residents working overnight are fatigued but do sleep, are not chronically sleep deprived, learn effectively immediately after being 'on-call' and learn in a 4-week ICU rotation. The pilot cluster randomized clinical trial of 12, 16 and 24h overnight duty suggests that patient safety is compromised with duty periods shorter than 24h: more harmful errors occurred in the 12h schedule, and residents' knowledge of patients and clinical decisions were worst in the 16h schedule. Mortality was similar. Resident wellbeing was worst in the 24h schedule, suggesting a trade-off between patient safety and resident wellbeing. Education was not assessed.

The 8 other randomized clinical trials of physician schedules are from the US; 2 studied residents (the providers of first line overnight medical care in Canadian hospitals), and 6 had low power for important effects on patient outcomes. None found differences in mortality or harmful errors or robustly examined educational outcomes.

With Canadian Institutes of Health Research bridge funding the investigators completed a Canada-wide survey showing that most ICU overnight in-house physician staffing is by residents, and a pilot of education outcomes demonstrating the feasibility, responsiveness and discriminative power of competency assessment.

Goals: To evaluate the effects of 16h and 24h resident duty schedules on patient mortality and safety, resident education and resident wellbeing.

Design: A cluster-randomized crossover trial will compare 16h vs. 24h overnight schedules for residents rotating to ICU. Eligible ICUs will care for adult patients, and are anticipated to have rotating residents performing overnight in-house duty.

Intervention: 16h and 24h overnight schedules will both be applied for 52 weeks at each site. Schedule crossover order will be randomly allocated (1:1 ratio). All in-house residents will participate in the schedule.

Consent will be obtained for resident measurements.

Outcomes: are in 3 domains, Patient, Resident Education and Resident Wellbeing. The primary outcome is hospital mortality to 90 days following index ICU admission. Mortality is objective, patient-relevant, frequent (12-20% in adult ICU) and reflects the quality and safety of care. The main resident education outcome is cognitive reasoning, and the main resident wellbeing outcome is emotional exhaustion.

Study of patients and residents in 18 ICUs has power \>90% for a 2% difference in mortality and of 90% for important differences in resident education and resident wellbeing. Analyses will use hierarchical regression models to account for clustering by ICU.

Expertise: The research team includes experts in patient safety, postgraduate medical education, randomized clinical trials, sleep, and 2 national-level decision-makers.

Impact: Key stakeholders actively seek high-quality data about the effects of common overnight schedules on patients and residents. Understanding the benefits and trade-offs will support creation of evidence informed policy about resident schedules and mitigation strategies. This knowledge will improve care for patients and help better train doctors.

Eligibility criteria: Inclusion Criteria for ICUs:

* Admit adult patients (≥18 years);
* Are anticipated to have sufficient rotating residents from Royal College of Physicians and Surgeons of Canada -accredited training programs to provide overnight in-house coverage for at least 20 overnight periods in 28 days; and
* Are willing to participate in the study (schedule randomization, measurements).

Inclusion Criteria for Patients:

• Patients admitted to ICU during either period of the study.

Inclusion Criteria for Residents:

* Are enrolled in an accredited specialty training program of the Royal College of Physicians and Surgeons of Canada (internal or emergency medicine, surgery, anaesthesia, other, but not critical care medicine),
* Are able to perform overnight in-house duty with supervision from critical care trainees and intensivists, and
* Have the first 4 weeks of their ICU rotation entirely in one period. Residents who have participated in the study previously will not complete the competency assessments, however will be eligible to participate in the wellbeing and description of learning activities.

Inclusion Criteria for Supervisors:

• Are Physicians responsible for the supervision of residents and other trainees in the ICU, and include Critical Care Trainees and Staff Physicians.

Inclusion Criteria for ICU frontline staff:

• Are Registered nurses, registered respiratory therapists, pharmacists, social workers, physiotherapists and occupational therapists, who provide care in the ICU.

Exclusion Criteria for ICUs:

* ICUs with no rotating residents performing overnight in-house duty.
* ICUs that are anticipating a major change in ICU staffing (e.g. in-house intensivist added or removed, in-house fellow added or removed) or
* Are unwilling to have either resident schedule randomized, to provide study measurements or both.

Exclusion Criteria for Patients:

• Patients will be excluded if they are in the ICU at the start of a study period.

Exclusion Criteria for Residents:

* Residents enrolled in a critical care medicine accredited specialty training program,
* Who are not able to perform overnight in-house duty,
* Where the first 4 weeks of their ICU rotation are not in one period,
* Where the length of their ICU rotation is less than 4 week.

Primary outcomes:
measure: Rate of Patient Mortality After Index ICU Admission (First ICU Admission within the study periods)
timeFrame: Up to 90 days following index ICU admission
measure: Resident Cognitive Reasoning-Script Concordance Test
timeFrame: During 4th week of ICU rotation
measure: Resident Burnout - Emotional Exhaustion
timeFrame: 4th week of ICU rotation
Secondary outcomes:
measure: Rate of ICU Mortality
timeFrame: Measured daily from ICU admission to ICU discharge. Estimated average is 7 days.
measure: Rate of Patient Adverse Events
timeFrame: During ICU stay and up to 3 days post ICU discharge
measure: Rate of Medication Error
timeFrame: During ICU stay and up to 3 days post ICU discharge
measure: Resident Procedural Competencies: Basic Airway Management
timeFrame: During 4th week of ICU rotation
measure: Resident Procedural Competencies: Central Venous Line
timeFrame: Week 4 of ICU rotation
measure: Resident Communication Competency
timeFrame: Week 4 of ICU rotation
measure: Resident Depersonalization
timeFrame: Week 4 of ICU rotation
measure: Resident Personal Accomplishment
timeFrame: Week 4 of ICU rotation
measure: Resident Health Rating
timeFrame: Twice per week during the first 4 weeks of a residents ICU rotation
measure: Resident Nighttime Sleepiness
timeFrame: Two days per week at 8pm, midnight and 4am during the first 4 weeks of a residents ICU rotation
measure: Resident Daytime Sleepiness
timeFrame: Two days per week at 8am, noon and 4pm during the first 4 weeks of a residents ICU rotation
Other outcomes:
measure: Rate of Patient ICU Re-admission
timeFrame: 48 hours post-ICU discharge
measure: Rate of Patient Treated Cardiac Arrest
timeFrame: During ICU stay and up to 3 days post ICU discharge
measure: Rate of Patient Bleeding
timeFrame: During ICU stay and up to 3 days post ICU discharge
measure: Rate of Patient Thrombosis/Embolism
timeFrame: During ICU stay and up to 3 days post ICU discharge
measure: Rate of Patient Cutaneous Injury
timeFrame: During ICU stay and up to 3 days post ICU discharge
measure: Rate of Patient Acquired Neurologic Injury
timeFrame: During ICU stay and up to 3 days post ICU discharge
measure: Rate of Patient Central Line or Endotracheal Tube Loss
timeFrame: During ICU stay and up to 3 days post ICU discharge
measure: Rate of Patient Adverse Drug Events
timeFrame: During ICU stay and up to 3 days post ICU discharge
measure: Rate of Patient Acquired Infection
timeFrame: During ICU stay and up to 3 days post ICU discharge
measure: ICU Resource Utilization: Length of Stay
timeFrame: Measured daily from the date of ICU admission to the date of ICU discharge for each enrolled patient. Estimated average is 7 days.
measure: ICU Resource Utilization: Duration of Mechanical Ventilation
timeFrame: From the date of a patients ICU admission to the date of that patient's ICU discharge. Estimated average is 7 days.
measure: ICU Resource Utilization: Duration of Acute dialysis
timeFrame: From the date of a patients ICU admission to the date of that patient's ICU discharge. Estimated average is 7 days.
measure: ICU Resource Utilization: Duration of Inhaled Pulmonary Vasodilators
timeFrame: From the date of a patients ICU admission to the date of that patient's ICU discharge. Estimated average is 7 days.
measure: ICU Resource Utilization: Duration of Mechanical Circulatory Support
timeFrame: From the date of a patients ICU admission to the date of that patient's ICU discharge. Estimated average is 7 days.
measure: ICU Resource Utilization: Duration of Inotrope-vasoactive therapy
timeFrame: From the date of a patients ICU admission to the date of that patient's ICU discharge. Estimated average is 7 days.
measure: ICU Resource Utilization: Duration of non-invasive mechanical ventilation
timeFrame: From the date of a patients ICU admission to the date of that patient's ICU discharge. Estimated average is 7 days.
measure: Resident Daily Activities
timeFrame: Twice per week during the first 4 weeks of a residents ICU rotation
measure: Resident Wellbeing: Weekly Description
timeFrame: During the first 4 weeks of a residents ICU rotation
measure: Resident Perception of Learning Climate
timeFrame: Week 4 of ICU rotation
measure: Duration of Resident sleep
timeFrame: During 7 days of the ICU rotation
measure: Rate of Resident Needle Stick Injuries
timeFrame: During 4 weeks of ICU
measure: Resident Motor Vehicle Collisions
timeFrame: Each Week of ICU rotation. Average duration 4 weeks.
measure: Supervising Physician Workload
timeFrame: Twice per week for duration of the study for 2 years at each site.
measure: Supervising Physician Perceptions of resident performance
timeFrame: Twice per week for duration of the study for 2 years at each site.
measure: Amount of Sleep in last 12 hours.
timeFrame: Twice per week during the first 4 weeks of a residents ICU rotation
measure: Number of Resident Symptoms in last 24 hours.
timeFrame: Twice per week during the first 4 weeks of a residents ICU rotation
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Chris Parshuram, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Dominique Piquette, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parshuram CS, Amaral AC, Ferguson ND, Baker GR, Etchells EE, Flintoft V, Granton J, Lingard L, Kirpalani H, Mehta S, Moldofsky H, Scales DC, Stewart TE, Willan AR, Friedrich JO; Canadian Critical Care Trials Group. Patient safety, resident well-being and continuity of care with different resident duty schedules in the intensive care unit: a randomized trial. CMAJ. 2015 Mar 17;187(5):321-9. doi: 10.1503/cmaj.140752. Epub 2015 Feb 9.