Intensive Care Unit Resident Scheduling Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Rate of Patient Mortality After Index ICU Admission (First ICU Admission within the study periods)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
16 hour schedule
All residents assigned to an ICU randomized to a 16h overnight schedule will complete 16h overnight calls not preceded by an 8h daytime shift.
干预措施: 16h overnight duty (Other)
16 hour schedule
All residents assigned to an ICU randomized to a 16h overnight schedule will complete 16h overnight calls not preceded by an 8h daytime shift.
干预措施: Handover training (Other)
24 hour schedule
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).
干预措施: 24h overnight duty (Other)
24 hour schedule
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).
干预措施: Handover training (Other)
结局指标
主要结局
Rate of Patient Mortality After Index ICU Admission (First ICU Admission within the study periods)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Resident Health Rating(Twice per week during the first 4 weeks of a residents ICU rotation)
- Rate of ICU Mortality(Measured daily from ICU admission to ICU discharge. Estimated average is 7 days.)
- Rate of Patient Adverse Events(During ICU stay and up to 3 days post ICU discharge)
- Rate of Medication Error(During ICU stay and up to 3 days post ICU discharge)
- Resident Procedural Competencies: Basic Airway Management(During 4th week of ICU rotation)
- Resident Nighttime Sleepiness(Two days per week at 8pm, midnight and 4am during the first 4 weeks of a residents ICU rotation)
- Resident Daytime Sleepiness(Two days per week at 8am, noon and 4pm during the first 4 weeks of a residents ICU rotation)
- Resident Procedural Competencies: Central Venous Line(Week 4 of ICU rotation)
- Resident Communication Competency(Week 4 of ICU rotation)
- Resident Depersonalization(Week 4 of ICU rotation)
- Resident Personal Accomplishment(Week 4 of ICU rotation)
研究者
Christopher Parshuram
Principal Investigator
The Hospital for Sick Children