NCT04176094 Intensive Care Unit Resident Scheduling Trial
| NCT ID | NCT04176094 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hospital for Sick Children |
| Condition | Patient Safety |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2019-11-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2019-11-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Chris Parshuram, MD
PRINCIPAL INVESTIGATOR
The Hospital for Sick Children
Frequently Asked Questions
Who can join the NCT04176094 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Patient Safety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04176094 currently recruiting?
Yes, NCT04176094 is actively recruiting participants. Contact the research team at weeda.zabih@sickkids.ca for enrollment information.
Where is the NCT04176094 trial being conducted?
This trial is being conducted at Toronto, Canada, Toronto, Canada, Toronto, Canada, Toronto, Canada and 1 additional location.
Who is sponsoring the NCT04176094 clinical trial?
NCT04176094 is sponsored by The Hospital for Sick Children. The principal investigator is Chris Parshuram, MD at The Hospital for Sick Children. The trial plans to enroll 20 participants.