Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04176094

Intensive Care Unit Resident Scheduling Trial

Led by The Hospital for Sick Children · Updated on 2025-04-11

20

Participants Needed

5

Research Sites

419 weeks

Total Duration

On this page

Sponsors

T

The Hospital for Sick Children

Lead Sponsor

S

Sunnybrook Health Sciences Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Intensive Care Unit Resident Scheduling Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ICUs must admit adult patients aged 18 years or older
  • ICUs must have sufficient rotating residents from accredited programs to provide at least 20 overnight in-house coverage periods in 28 days
  • ICUs must be willing to participate in schedule randomization and study measurements
  • Patients admitted to ICU during either study period are included
  • Residents must be enrolled in accredited specialty training programs (internal medicine, emergency medicine, surgery, anaesthesia, or others except critical care medicine)
  • Residents must be able to perform overnight in-house duty with supervision
  • Residents must have the first 4 weeks of their ICU rotation entirely in one period
  • Supervisors must be physicians responsible for resident supervision in ICU, including critical care trainees and staff physicians
  • ICU frontline staff including registered nurses, respiratory therapists, pharmacists, social workers, physiotherapists, and occupational therapists providing ICU care are included
Not Eligible

You will not qualify if you...

  • ICUs without rotating residents performing overnight in-house duty
  • ICUs anticipating major staffing changes such as adding or removing in-house intensivists or fellows
  • ICUs unwilling to have resident schedules randomized or to provide study measurements
  • Patients who are in ICU at the start of a study period
  • Residents enrolled in critical care medicine accredited specialty training programs
  • Residents unable to perform overnight in-house duty
  • Residents whose first 4 weeks of ICU rotation are not in one continuous period
  • Residents with ICU rotations shorter than 4 weeks

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 5 locations

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Completed

2

St Michael's Hospital

Toronto, Ontario, Canada, M5B1W8

Completed

3

Toronto General Hospital

Toronto, Ontario, Canada, M5G 2C4

Completed

4

Mount Sinai Hospital

Toronto, Ontario, Canada, M5G1X5

Completed

5

Toronto Western Hospital

Toronto, Ontario, Canada, M5T 2S8

Actively Recruiting

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Research Team

W

Weeda Zabih

CONTACT

J

Jordan Dang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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