Intensive Care Unit Resident Scheduling Trial
- Conditions
- Well-beingPatient SafetyEducation
- Interventions
- Other: 24h overnight dutyOther: 16h overnight dutyOther: Handover training
- Registration Number
- NCT04176094
- Lead Sponsor
- The Hospital for Sick Children
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 16 hour schedule Handover training All 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 Handover training 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). 24 hour schedule 24h overnight duty 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). 16 hour schedule 16h overnight duty All residents assigned to an ICU randomized to a 16h overnight schedule will complete 16h overnight calls not preceded by an 8h daytime shift.
- Primary Outcome Measures
Name Time Method Rate of Patient Mortality After Index ICU Admission (First ICU Admission within the study periods) 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 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 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.
- Secondary Outcome Measures
Name Time Method Rate of ICU Mortality Measured daily from ICU admission to ICU discharge. Estimated average is 7 days. Patient death occurring during ICU admission.
Rate of Patient Adverse Events During ICU stay and up to 3 days post ICU discharge 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.
Rate of Medication Error During ICU stay and up to 3 days post ICU discharge Reported or documented: dosing errors, wrong medication, or drug given to wrong patient.
Resident Procedural Competencies: Basic Airway Management During 4th week of ICU rotation 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.Resident Nighttime Sleepiness Two days per week at 8pm, midnight and 4am during the first 4 weeks of a residents ICU rotation 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.
Resident Daytime Sleepiness Two days per week at 8am, noon and 4pm during the first 4 weeks of a residents ICU rotation 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.
Resident Procedural Competencies: Central Venous Line Week 4 of ICU rotation 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.Resident Communication Competency Week 4 of ICU rotation 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.Resident Depersonalization Week 4 of ICU rotation 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.
Resident Personal Accomplishment Week 4 of ICU rotation 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.
Resident Health Rating Twice per week during the first 4 weeks of a residents ICU rotation 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.
Trial Locations
- Locations (5)
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
St Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada