Patient SafetyInCURSNCT04176094
Intensive Care Unit Resident Scheduling Trial
A study testing 16h overnight duty, 24h overnight duty and Handover training in people with Patient Safety and Well-being, run by The Hospital for Sick Children at 5 sites in Canada.
Trial 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'). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Safety, Well-being, Education
- What is being tested?
- 16h overnight duty, 24h overnight duty and Handover training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesCanada
- Study dates
- 18 Nov 2019to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Patients admitted to ICU during either period of the study.
- 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
Show all 9Show fewer
- 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.
- Are Physicians responsible for the supervision of residents and other trainees in the ICU, and include Critical Care Trainees and Staff Physicians.
- Are Registered nurses, registered respiratory therapists, pharmacists, social workers, physiotherapists and occupational therapists, who provide care in the ICU.
Who cannot join
- 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.
- Patients will be excluded if they are in the ICU at the start of a study period.
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Canada5 sites, 1 recruiting
- Completed
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
- Completed
St Michael's Hospital
Toronto, Ontario, M5B1W8
- Completed
Toronto General Hospital
Toronto, Ontario, M5G 2C4
- Completed
Mount Sinai Hospital
Toronto, Ontario, M5G1X5
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Maria Jogova, MD, (416) 603-2581, maria.jogova@uhn.ca
Maria Jogova, MD
About this study
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.
Read more
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.
Read the detailed description
Background: Strategies to manage residents' fatigue must balance patient safety, resident education and resident wellbeing. The trade-offs among these are not fully understood. A Canadian cluster-randomized clinical trial will provide urgently needed evidence to inform resident scheduling practice and policy.
Previous work questions assumptions used to justify duty hour reduction. The investigators found residents working overnight are fatigued but do sleep, are not chronically sleep deprived, learn effectively immediately after being 'on-call' and learn in a 4-week ICU rotation. The pilot cluster randomized clinical trial of 12, 16 and 24h overnight duty suggests that patient safety is compromised with duty periods shorter than 24h: more harmful errors occurred in the 12h schedule, and residents' knowledge of patients and clinical decisions were worst in the 16h schedule. Mortality was similar. Resident wellbeing was worst in the 24h schedule, suggesting a trade-off between patient safety and resident wellbeing. Education was not assessed.
The 8 other randomized clinical trials of physician schedules are from the US; 2 studied residents (the providers of first line overnight medical care in Canadian hospitals), and 6 had low power for important effects on patient outcomes. None found differences in mortality or harmful errors or robustly examined educational outcomes.
With Canadian Institutes of Health Research bridge funding the investigators completed a Canada-wide survey showing that most ICU overnight in-house physician staffing is by residents, and a pilot of education outcomes demonstrating the feasibility, responsiveness and discriminative power of competency assessment.
Goals: To evaluate the effects of 16h and 24h resident duty schedules on patient mortality and safety, resident education and resident wellbeing.
Design: A cluster-randomized crossover trial will compare 16h vs. 24h overnight schedules for residents rotating to ICU. Eligible ICUs will care for adult patients, and are anticipated to have rotating residents performing overnight in-house duty.
Intervention: 16h and 24h overnight schedules will both be applied for 52 weeks at each site. Schedule crossover order will be randomly allocated (1:1 ratio). All in-house residents will participate in the schedule.
Consent will be obtained for resident measurements.
Outcomes: are in 3 domains, Patient, Resident Education and Resident Wellbeing. The primary outcome is hospital mortality to 90 days following index ICU admission. Mortality is objective, patient-relevant, frequent (12-20% in adult ICU) and reflects the quality and safety of care. The main resident education outcome is cognitive reasoning, and the main resident wellbeing outcome is emotional exhaustion.
Study of patients and residents in 18 ICUs has power >90% for a 2% difference in mortality and of 90% for important differences in resident education and resident wellbeing. Analyses will use hierarchical regression models to account for clustering by ICU.
Expertise: The research team includes experts in patient safety, postgraduate medical education, randomized clinical trials, sleep, and 2 national-level decision-makers.
Impact: Key stakeholders actively seek high-quality data about the effects of common overnight schedules on patients and residents. Understanding the benefits and trade-offs will support creation of evidence informed policy about resident schedules and mitigation strategies. This knowledge will improve care for patients and help better train doctors.
- Conditions
- Patient Safety, Well-being, Education
- Being tested
- 16h overnight duty, 24h overnight duty, Handover training
- Keywords
- health service and systems research, population health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16h overnight dutyOther
schedule observed by participating ICUs.
24h overnight dutyOther
schedule observed by participating ICUs.
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.
| Study group | Role | What they receive |
|---|---|---|
| 16 hour schedule | Experimental | All residents assigned to an ICU randomized to a 16h overnight schedule will complete 16h overnight calls not preceded by an 8h daytime shift. Receives: Other: 16h overnight duty; Other: Handover training |
| 24 hour schedule | Active comparator | 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). Receives: Other: 24h overnight duty; Other: Handover training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Patient Mortality After Index ICU Admission (First ICU Admission within the study periods)
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.
Measured: Up to 90 days following index ICU admission
Resident Cognitive Reasoning-Script Concordance Test
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.
Measured: During 4th week of ICU rotation
Resident Burnout - Emotional Exhaustion
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.
Measured: 4th week of ICU rotation
Secondary outcomes (11)
Rate of ICU Mortality
Patient death occurring during ICU admission.
Measured: Measured daily from ICU admission to ICU discharge. Estimated average is 7 days.
Rate of Patient Adverse Events
Unplanned injury arising as a consequence of medical care during the time the patient was in the ICU that is associated with morbidity, requires treatment, prolongs hospital stay, or results in disability at discharge.
Measured: During ICU stay and up to 3 days post ICU discharge
Rate of Medication Error
Reported or documented: dosing errors, wrong medication, or drug given to wrong patient.
Measured: During ICU stay and up to 3 days post ICU discharge
Resident Procedural Competencies: Basic Airway Management
End-rotation simulation. Procedural skills will be assessed using the Objective Structured Assessment of Technical Skills Global Rating Scale. The scale measures 7 domains, including the participant's knowledge of instruments, respect for tissue, and knowledge of the procedure.
Sub-scale ratings are averaged to create a global score: 1 is the minimum score and indicates the lowest performance; 5 is the maximum score and indicates the highest performance.
Measured: During 4th week of ICU rotation
Resident Procedural Competencies: Central Venous Line
End-rotation simulation. Procedural skills will be assessed using the Objective Structured Assessment of Technical Skills Global Rating Scale. The scale measures 7 domains, including the participant's knowledge of instruments, respect for tissue, and knowledge of the procedure.
Sub-scale ratings from 1 to 5 are averaged to create a global score: 1 is the minimum score and indicates the lowest performance; 5 is the maximum score and indicates the highest performance.
Measured: Week 4 of ICU rotation
Resident Communication Competency
End-rotation simulation. Assessment of communication skills during a goals of care discussion with a simulated family member using a communication Analytic Global Rating Scale (AGRS). The scale will be used to assess 5 domains of the participant's communication: empathy, verbal expression, degree of coherence in the interview, non-verbal expression and an overall assessment of knowledge and skills.
The sub-scale ratings are averaged to create a global score: 1 is the minimum score and indicates the lowest performance; 5 is the maximum score and indicates the highest performance.
Measured: Week 4 of ICU rotation
Resident Depersonalization
The Maslach Burnout Inventory Depersonalization sub-scale will be used at week 4 of the resident ICU rotation. The range of scores is from 0 to 30. Higher scores indicate greater degrees of depersonalization. Lower scores indicate less depersonalization.
Measured: Week 4 of ICU rotation
Resident Personal Accomplishment
The Maslach Burnout Inventory Personal Accomplishment sub-scale will be used at week 4 of the resident ICU rotation. The range of scores is from 0 to 48. Lower scores indicate less personal accomplishment. Higher scores indicate more personal accomplishment.
Measured: Week 4 of ICU rotation
Resident Health Rating
Residents will rate their health on the day of survey. A score of 0 (the lowest value) represents the worst health and a score of 100 (the highest value) represents the best health the respondent can imagine.
Measured: Twice per week during the first 4 weeks of a residents ICU rotation
Resident Nighttime Sleepiness
Assessment of resident nighttime sleepiness using the Stanford Sleepiness Scale. The scale allows participants to indicate their level of sleepiness from on a 7-point scale from 1 to 7. A rating of 1 represents the least sleepy (most awake) and a rating of 7 the most sleepy. An additional (8th) response " I was asleep at the time of the assessment" is used if the resident was asleep at the time of the assessment.
Measured: Two days per week at 8pm, midnight and 4am during the first 4 weeks of a residents ICU rotation
Resident Daytime Sleepiness
Assessment of resident daytime sleepiness using the Stanford Sleepiness Scale. The scale allows participants to indicate their level of sleepiness from on a 7-point scale from 1 to 7. A rating of 1 represents the least sleepy (most awake) and a rating of 7 the most sleepy. An additional (8th) response " I was asleep at the time of the assessment" is used if the resident was asleep at the time of the assessment.
Measured: Two days per week at 8am, noon and 4pm during the first 4 weeks of a residents ICU rotation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start18 Nov 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A cluster-randomized crossover trial will compare 16h vs. 24h overnight schedules for residents completing an ICU rotation.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Responsible party
- Principal investigator, Christopher Parshuram, The Hospital for Sick Children
- Investigators
- Chris Parshuram, MD, Principal investigator, The Hospital for Sick ChildrenDominique Piquette, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176094
- Sponsor's protocol ID
- 1744
- Acronym
- InCURS
- Status last verified
- Apr 2025
- First submitted
- 4 Oct 2019
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parshuram CS, Amaral AC, Ferguson ND, Baker GR, Etchells EE, Flintoft V, Granton J, Lingard L, Kirpalani H, Mehta S, Moldofsky H, Scales DC, Stewart TE, Willan AR, Friedrich JO; Canadian Critical Care Trials Group. Patient safety, resident well-being and continuity of care with different resident duty schedules in the intensive care unit: a randomized trial. CMAJ. 2015 Mar 17;187(5):321-9. doi: 10.1503/cmaj.140752. Epub 2015 Feb 9.
PubMed 25667258
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Care Unit Resident Scheduling Trial
- ClinicalTrials.gov ID
- NCT04176094
- Acronym / sponsor ID
- InCURS / 1744
- Conditions
- Patient Safety, Well-being, Education
- Keywords
- health service and systems research, population health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Strategies to manage residents' fatigue must balance patient safety, resident education and resident wellbeing. The trade-offs among these are not fully understood. A Canadian cluster-randomized clinical trial will provide urgently needed evidence to inform resident scheduling practice and policy.
Previous work questions assumptions used to justify duty hour reduction. The investigators found residents working overnight are fatigued but do sleep, are not chronically sleep deprived, learn effectively immediately after being 'on-call' and learn in a 4-week ICU rotation. The pilot cluster randomized clinical trial of 12, 16 and 24h overnight duty suggests that patient safety is compromised with duty periods shorter than 24h: more harmful errors occurred in the 12h schedule, and residents' knowledge of patients and clinical decisions were worst in the 16h schedule. Mortality was similar. Resident wellbeing was worst in the 24h schedule, suggesting a trade-off between patient safety and resident wellbeing. Education was not assessed.
The 8 other randomized clinical trials of physician schedules are from the US; 2 studied residents (the providers of first line overnight medical care in Canadian hospitals), and 6 had low power for important effects on patient outcomes. None found differences in mortality or harmful errors or robustly examined educational outcomes.
With Canadian Institutes of Health Research bridge funding the investigators completed a Canada-wide survey showing that most ICU overnight in-house physician staffing is by residents, and a pilot of education outcomes demonstrating the feasibility, responsiveness and discriminative power of competency assessment.
Goals: To evaluate the effects of 16h and 24h resident duty schedules on patient mortality and safety, resident education and resident wellbeing.
Design: A cluster-randomized crossover trial will compare 16h vs. 24h overnight schedules for residents rotating to ICU. Eligible ICUs will care for adult patients, and are anticipated to have rotating residents performing overnight in-house duty.
Intervention: 16h and 24h overnight schedules will both be applied for 52 weeks at each site. Schedule crossover order will be randomly allocated (1:1 ratio). All in-house residents will participate in the schedule.
Consent will be obtained for resident measurements.
Outcomes: are in 3 domains, Patient, Resident Education and Resident Wellbeing. The primary outcome is hospital mortality to 90 days following index ICU admission. Mortality is objective, patient-relevant, frequent (12-20% in adult ICU) and reflects the quality and safety of care. The main resident education outcome is cognitive reasoning, and the main resident wellbeing outcome is emotional exhaustion.
Study of patients and residents in 18 ICUs has power >90% for a 2% difference in mortality and of 90% for important differences in resident education and resident wellbeing. Analyses will use hierarchical regression models to account for clustering by ICU.
Expertise: The research team includes experts in patient safety, postgraduate medical education, randomized clinical trials, sleep, and 2 national-level decision-makers.
Impact: Key stakeholders actively seek high-quality data about the effects of common overnight schedules on patients and residents. Understanding the benefits and trade-offs will support creation of evidence informed policy about resident schedules and mitigation strategies. This knowledge will improve care for patients and help better train doctors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster-randomized crossover trial will compare 16h vs. 24h overnight schedules for residents completing an ICU rotation.
| Arm | Type | Receives |
|---|---|---|
| 16 hour schedule | Experimental | Other: 16h overnight duty, Other: Handover trainingAll residents assigned to an ICU randomized to a 16h overnight schedule will complete 16h overnight calls not preceded by an 8h daytime shift. |
| 24 hour schedule | Active comparator | Other: 24h overnight duty, Other: Handover trainingAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
- Patients admitted to ICU during either period of the study.
- 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),
Key exclusion criteria (8 listed)
- 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.
- Patients will be excluded if they are in the ICU at the start of a study period.
- Residents enrolled in a critical care medicine accredited specialty training program,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 16h overnight dutyschedule observed by participating ICUs. | Other | 16 hour schedule |
| 24h overnight dutyschedule observed by participating ICUs. | Other | 24 hour schedule |
| Handover trainingFormal 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. | Other | 16 hour schedule, 24 hour schedule |
Primary outcome
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
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
Time frame: 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
Time frame: 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.
11 secondary outcomes
Rate of ICU Mortality
Time frame: Measured daily from ICU admission to ICU discharge. Estimated average is 7 days.
Rate of Patient Adverse Events
Time frame: During ICU stay and up to 3 days post ICU discharge
Rate of Medication Error
Time frame: During ICU stay and up to 3 days post ICU discharge
Resident Procedural Competencies: Basic Airway Management
Time frame: During 4th week of ICU rotation
Resident Procedural Competencies: Central Venous Line
Time frame: Week 4 of ICU rotation
Resident Communication Competency
Time frame: Week 4 of ICU rotation
Resident Depersonalization
Time frame: Week 4 of ICU rotation
Resident Personal Accomplishment
Time frame: Week 4 of ICU rotation
Resident Health Rating
Time frame: Twice per week during the first 4 weeks of a residents ICU rotation
Resident Nighttime Sleepiness
Time frame: Two days per week at 8pm, midnight and 4am during the first 4 weeks of a residents ICU rotation
Resident Daytime Sleepiness
Time frame: Two days per week at 8am, noon and 4pm during the first 4 weeks of a residents ICU rotation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Background: PubMed 25667258Parshuram CS, Amaral AC, Ferguson ND, Baker GR, Etchells EE, Flintoft V, Granton J, Lingard L, Kirpalani H, Mehta S, Moldofsky H, Scales DC, Stewart TE, Willan AR, Friedrich JO; Canadian Critical Care Trials Group. Patient safety, resident well-being and continuity of care with different resident duty schedules in the intensive care unit: a randomized trial. CMAJ. 2015 Mar 17;187(5):321-9. doi: 10.1503/cmaj.140752. Epub 2015 Feb 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chris Parshuram, MD principal investigator
The Hospital for Sick Children
Dominique Piquette, MD principal investigator
Sunnybrook Health Sciences Centre
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 16h overnight duty, 24h overnight duty and Handover training in people with Patient Safety and Well-being, run by The Hospital for Sick Children at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weeda Zabih (416-813-7654 ext. 303873, weeda.zabih@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04176094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.