Intensive Care Unit Resident Scheduling Trial
- 2 groups
- 5 sites in Toronto
- Recruiting
Interventions
- Other intervention
16h overnight duty
schedule observed by participating ICUs.
- Other intervention
24h overnight duty
schedule observed by participating ICUs.
- Other intervention
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.
Canadian Sites (5)
1 of 5 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario
- Completed
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
Eligibility Criteria
See who this study is looking for34 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →, measurements).
- +Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → for Patients:
- +Patients admitted to ICU during either period of the study.
- +Inclusion Criteria for Residents:
- +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 CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → 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 enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → 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.
- +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),
Exclusion
- −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 randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →, to provide study measurements or both.
- −Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → for Patients:
- −Patients will be excluded if they are in the ICU at the start of a study period.
- −Exclusion Criteria for Residents:
- −Residents enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → 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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is looking at how care is delivered and organised, rather than at a treatment itself.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives one or more of: 16h overnight duty and Handover training.
Registry label: A: 16 hour schedule
Group B, the comparison group, receives one or more of: 24h overnight duty and Handover training.
Registry label: B: 24 hour schedule
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 20 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: Up to 90 days following index ICU admission.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Rate of Patient Mortality After Index ICU Admission (First ICU Admission within the study periods) — measured over Up to 90 days following index ICU admission.
Resident Cognitive Reasoning-Script Concordance Test — measured over During 4th week of ICU rotation.
Resident Burnout - Emotional Exhaustion — measured over 4th week of ICU rotation.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04176094 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 16h overnight dutyOther
schedule observed by participating ICUs.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About 24h overnight dutyOther
schedule observed by participating ICUs.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Handover trainingOther
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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 90 days following index ICU admission.
The study as a whole is currently expected to finish around 2027-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 20 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.