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Recruiting Not applicable

Intensive Care Unit Resident Scheduling Trial

NCT04176094 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2019-11-18
Last updated
2025-04-11

Condition(s) studied

Patient SafetyWell-beingEducation

Investigational drug(s) / intervention(s)

16h overnight duty24h overnight dutyHandover training

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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)

FacilityCityRegionStatus
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
Official registry record

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