Intensive Care Unit Resident Scheduling Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
16h overnight duty: schedule observed by participating ICUs.
24h overnight duty: schedule observed by participating ICUs.
Handover training: Formal handover training for residents in both interventions. ICUs with a pre-existing standardized handover training and process will be asked to continue handover practices throughout the study. In ICUs without a pre-existing standardized handover training and process, ICU education directors will be provided with materials to include in orientation of residents to the ICU and local training to ICU staff physicians at least once per year.
Study 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.
Eligibility
Primary outcome measure(s)
- Rate of Patient Mortality After Index ICU Admission (First ICU Admission within the study periods) — Up to 90 days following index ICU admission
Rate of Hospital mortality to 90 days following index ICU admission. Patients discharged from hospital before 90 days will be assumed to be alive at 90 days. - Resident Cognitive Reasoning-Script Concordance Test — During 4th week of ICU rotation
A Script Concordance Test will be administered in week 4 of the ICU resident rotation. Scoring was derived by administering the Script Concordance Test to an expert panel. The higher the overall rating for a resident, the closer their responses align with the expert panel. The minimum score is 0 and the maximum is 35. - Resident Burnout - Emotional Exhaustion — 4th week of ICU rotation
The Emotional Exhaustion sub-scale of the Maslach Burnout Inventory will be measured in week four of the residents ICU rotation. Lower scores mean less emotional exhaustion, higher scores mean more emotional exhaustion. The lowest score is 0 and the highest score is 54.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Completed |
| St Michael's Hospital | Toronto | Ontario | Completed |
| Toronto General Hospital | Toronto | Ontario | Completed |
| Mount Sinai Hospital | Toronto | Ontario | Completed |
| Toronto Western Hospital | Toronto | Ontario | Recruiting |
More The Hospital for Sick Children trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04176094 on ClinicalTrials.gov ↗ ← All trials in Canada