Recruiting

Observational StudyIntensive Care Unit Resident Scheduling Trial

Sponsor:

The Hospital for Sick Children

Code:

NCT04176094

Conditions

Patient Safety

Well-being

Education

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

16h overnight duty

24h overnight duty

Handover training

Study Details

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.

Conditions

Patient Safety

Well-being

Education

Study ID

NCT04176094

Start date

Nov 18, 2019

Status verified date

Apr, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 16 hour schedule

All residents assigned to an ICU randomized to a 16h overnight schedule will complete 16h overnight calls not preceded by an 8h daytime shift.

active comparator: 24 hour schedule

All residents assigned to an ICU randomized to a 24h overnight schedule will complete 24h shifts when scheduled for overnight calls (8h daytime shift followed by a 16h overnight call).

Interventions

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.

Primary outcome measure

Rate of Patient Mortality After Index ICU Admission (First ICU Admission within the study periods) [ Time Frame: Up to 90 days following index ICU admission ]
Resident Cognitive Reasoning-Script Concordance Test [ Time Frame: During 4th week of ICU rotation ]
Resident Burnout - Emotional Exhaustion [ Time Frame: 4th week of ICU rotation ]

Central Contacts and Locations

Central contacts

Weeda Zabih

416-813-7654 weeda.zabih@sickkids.ca

Jordan Dang

416-813-7654 jordan.dang@sickkids.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Maria Jogova, MD

(416) 603-2581 maria.jogova@uhn.ca

Principal Investigator:

Jeffery Singh, MD

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Apr 11, 2025

Last verified

Apr, 2025

Keywords

health service and systems research
population health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2025-04-11.