Evaluating different overnight duty schedules for ICU residents

Intensive Care Unit Resident Scheduling Trial

This study tests whether different overnight work schedules for ICU residents can improve patient safety and the learning experience for doctors in training.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Hospital for Sick Children (Academic / other)
• Locations: 5 sites (Toronto, Ontario and 4 other locations)
• Trial ID: NCT04176094 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of varying overnight duty schedules (16-hour vs. 24-hour shifts) on patient safety, resident education, and wellbeing in intensive care units across Canada. By employing a cluster-randomized design, the study aims to gather evidence on how these schedules affect both patient outcomes and the learning experiences of medical residents. The trial will include adult patients admitted to participating ICUs and residents enrolled in accredited specialty training programs. The findings will help inform policies regarding resident work-hour regulations in Canada.

Who should consider this trial

Good fit: Ideal candidates for this study are adult patients admitted to participating intensive care units during the study periods.

Not a fit: Patients who are not admitted to the ICU or are under 18 years old may not receive any benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved patient care and resident wellbeing by optimizing work-hour regulations for medical trainees.

How similar studies have performed: Previous studies on resident work-hours have shown mixed results, indicating that while some approaches may improve resident wellbeing, they may also compromise patient safety, making this study's focus on the Canadian context particularly novel.

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.

Where this trial is running

Toronto, Ontario and 4 other locations

• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Completed)
• St Michael's Hospital — Toronto, Ontario, Canada (Completed)
• Toronto General Hospital — Toronto, Ontario, Canada (Completed)
• Mount Sinai Hospital — Toronto, Ontario, Canada (Completed)
• Toronto Western Hospital — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Chris Parshuram, MD — The Hospital for Sick Children
• Study coordinator: Weeda Zabih

Conditions Patient Safety; Well-being; Education; health service and systems research; population health