Intensive Care Unit Resident Scheduling Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intensive Care Unit Resident Scheduling Trial

Conditions
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Patient Safety, Well-being, Education

Intervention / Treatment
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* Other: 16h overnight duty
* Other: 24h overnight duty
* Other: Handover training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A cluster-randomized crossover trial will compare 16h vs. 24h overnight schedules for residents completing an ICU rotation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 16 hour schedule<br>All residents assigned to an ICU randomized to a 16h overnight schedule will complete 16h overnight calls not preceded by an 8h daytime shift. | Other: 16h overnight duty<br>* schedule observed by participating ICUs.<br>Other: Handover training<br>* 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.<br>|
| Active Comparator: 24 hour schedule<br>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). | Other: 24h overnight duty<br>* schedule observed by participating ICUs.<br>Other: Handover training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 4th week of ICU rotation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ICU Mortality | Patient death occurring during ICU admission. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Two days per week at 8am, noon and 4pm during the first 4 weeks of a residents ICU rotation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health service and systems research, population health