Resident Work Schedules for Patient Safety

(InCURS Trial)

Overseen By Kristen Middaugh, BScN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Critical care residents, Short ICU rotation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment involving 16h overnight duty, 24h overnight duty, and handover training for patient safety?

Research shows that limiting work shifts to 16 hours can reduce serious medical errors and fatigue-related mistakes, improving patient safety. Additionally, residents working shorter shifts report fewer attentional failures and improved morale, which can enhance overall patient care. ^{1 2 3 4 5}

Is it safe for medical residents to work long overnight shifts?

Research shows that long overnight shifts for medical residents can lead to increased risks of making serious medical errors, suffering injuries, and having accidents, especially when compared to shorter shifts. These risks are due to sleep deprivation and fatigue, which affect both the safety of the residents and their patients. ^{1 3 6 7 8}

How does the 16h vs. 24h overnight duty treatment differ from other treatments for patient safety?

This treatment focuses on adjusting the work schedules of medical residents to improve patient safety by reducing fatigue-related errors. Unlike traditional 24-hour shifts, the 16-hour shifts aim to decrease the risk of medical errors and occupational injuries by allowing residents more rest, which is not a standard approach in other treatments for patient safety. ^{3 8 9 10 11}

Research Team

Dominique Piquette, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Chris Parshuram, MD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

This trial is for ICU residents in Canada who are enrolled in Royal College-accredited programs and can work overnight shifts. It includes adult patients (≥18 years) admitted to the ICU, as well as supervising physicians and other healthcare professionals working there. Residents who've done the study before won't do competency tests again but can participate otherwise.

Inclusion Criteria

There should be enough doctors available to work overnight for at least 24 nights in a month.

You are okay with following the study's schedule for random testing and measurements.

I can perform overnight duties in a hospital with supervision.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Residents are assigned to either a 16-hour or 24-hour overnight schedule in the ICU

52 weeks

Continuous rotation in ICU

Evaluation

Assessment of patient outcomes, resident education, and resident wellbeing

4 weeks

End-rotation assessments

Follow-up

Participants are monitored for safety and effectiveness after intervention

Up to 90 days

Treatment Details

Interventions

• 16h overnight duty
• 24h overnight duty
• Handover training

Trial Overview The study compares two shift schedules for ICU residents: one with 16-hour overnight duty and another with 24-hour shifts. It aims to measure how these schedules affect patient care outcomes like mortality rates, potential harm from care, resident education on managing illnesses and procedures, communication skills, fatigue levels, sleepiness, and burnout.

Participant Groups

Group I: 16 hour schedule Experimental Treatment 2 Interventions

All residents assigned to an ICU randomized to a 16h overnight schedule will complete 16h overnight calls not preceded by an 8h daytime shift.

Group II: 24 hour schedule Active Control 2 Interventions

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).

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

Findings from Research

A review of 72 high-quality studies on resident duty hours reforms (DHRs) found that while patient safety and resident well-being generally improved, there was a perceived negative impact on the quality of education and training for residents.

Most studies indicated no significant change in mortality and complication rates after implementing DHRs, but they did show an increase in hospital costs, highlighting the need for further research to balance education quality with patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Narrative Review of High-Quality Literature on the Effects of Resident Duty Hours Reforms. Lin, H., Lin, E., Auditore, S., et al.[2022]

Implementing a night shift system for residents limited their work hours to 75 per week, reducing sleep deprivation and improving overall morale without needing additional staff.

Despite the changes, residents maintained the same level of exposure to operative cases, and their learning outcomes, as measured by in-training examinations, showed improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A method to limit working hours and reduce sleep deprivation in an obstetrics and gynecology residency program. Carey, JC., Fishburne, JI.[2009]

Nurses working shifts longer than 12.5 hours and physicians-in-training on > 24-hour shifts face significantly increased risks of decreased vigilance, occupational injuries, and serious medical errors, highlighting the dangers of extended work hours.

Evidence shows that on-call residents experience twice as many attentional failures and 36% more serious medical errors during overnight shifts, with a staggering 300% increase in fatigue-related errors that can lead to patient deaths, indicating an urgent need for safer work-hour regulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of health care provider work hours and sleep deprivation on safety and performance. Lockley, SW., Barger, LK., Ayas, NT., et al.[2022]

Implementing a resident schedule with shifts no longer than 16 hours did not negatively impact patient care metrics such as 30-day mortality, readmission rates, or length of stay, based on a study involving 196 patient care episodes.

While residents worked fewer hours overall during the intervention, they reported feeling less prepared for patient cross-cover and experienced more instances of having less than 10 hours off between shifts, indicating potential challenges in education and work-life balance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 16-hour duty periods on patient care and resident education. McCoy, CP., Halvorsen, AJ., Loftus, CG., et al.[2022]

The implementation of an overnight call shift (OCS) system in a pediatric residency program was viewed positively by 90.2% of the 41 surveyed residents, indicating it improved their working conditions.

While 80.4% of residents felt that patient care quality improved under the OCS, there were concerns about reduced educational emphasis, suggesting a need for policies that balance work conditions with educational quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric resident perceptions of shift work in ward rotations. Nomura, O., Mishina, H., Jasti, H., et al.[2018]

A study comparing adverse drug events (ADEs) before and after implementing an 80-hour work limit for medical residents found no significant changes in the number of confirmed ADEs, with 194 reported before and 172 after the limit.

The rate of preventable ADEs also remained stable, showing 21 before and 22 after the work hour restriction, indicating that limiting resident work hours did not impact the overall safety related to medication administration in the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospitalwide adverse drug events before and after limiting weekly work hours of medical residents to 80. Mycyk, MB., McDaniel, MR., Fotis, MA., et al.[2019]

In a study involving 47 residents across 971 ICU admissions, no significant differences in patient safety outcomes, such as adverse events or mortality rates, were found between 24-, 16-, and 12-hour resident duty schedules.

While shorter shifts did not improve patient safety, residents on the 24-hour schedule reported more severe physical symptoms, indicating a potential trade-off between resident well-being and patient care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety, resident well-being and continuity of care with different resident duty schedules in the intensive care unit: a randomized trial. Parshuram, CS., Amaral, AC., Ferguson, ND., et al.[2022]

In a study involving 106 internal medicine interns, implementing a protected sleep period during overnight calls did not significantly improve assessments of burnout, depression, or empathy compared to those without such periods.

However, the amount of sleep obtained while on call was linked to lower emotional exhaustion and depersonalization, suggesting that more sleep may help reduce certain aspects of burnout, even if the protected sleep period itself did not show clear benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of protected sleep period for internal medicine interns on overnight call on depression, burnout, and empathy. Shea, JA., Bellini, LM., Dinges, DF., et al.[2021]

A shift-work schedule combined with a structured sign-out curriculum for critical care fellows resulted in a significant decrease in the length of stay in the intensive care unit (ICU) from 8.4 days to 5.7 days, indicating improved efficiency in patient management.

There were no significant differences in ICU mortality, readmission rates, or family satisfaction between the shift-work model and traditional call schedules, suggesting that the shift model maintains patient safety and care quality while being preferred by nursing staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of shift scheduling with standardized sign-out to improve continuity of care in intensive care units. Emlet, LL., Al-Khafaji, A., Kim, YH., et al.[2022]

A study involving 20 surgical novices found that 24 hours of sleep deprivation did not significantly impact their overall performance in computer-simulated laparoscopic tasks, including total time and average speed.

While sleep deprivation resulted in a longer instrument path length in one of the tasks, error rates and precision remained unchanged, suggesting that surgical novices can maintain their performance levels despite lack of sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Sleep Deprivation on Surgical Laparoscopic Performance in Novices: A Computer-based Crossover Study. Leu, S., Staerkle, RF., Gaukel, S., et al.[2019]

A systematic review of 64 studies found that shorter shifts for medical interns are associated with fewer medical errors and injuries, suggesting that reducing shift length can improve patient safety.

Despite the encouragement of protected sleep time (naps), adherence among residents was poor, indicating that simply recommending naps may not be effective in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review: association of shift length, protected sleep time, and night float with patient care, residents' health, and education. Reed, DA., Fletcher, KE., Arora, VM.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Narrative Review of High-Quality Literature on the Effects of Resident Duty Hours Reforms. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A method to limit working hours and reduce sleep deprivation in an obstetrics and gynecology residency program. [2009]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of health care provider work hours and sleep deprivation on safety and performance. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effect of 16-hour duty periods on patient care and resident education. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Pediatric resident perceptions of shift work in ward rotations. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Hospitalwide adverse drug events before and after limiting weekly work hours of medical residents to 80. [2019]

7. Canada pubmed.ncbi.nlm.nih.gov

Patient safety, resident well-being and continuity of care with different resident duty schedules in the intensive care unit: a randomized trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of protected sleep period for internal medicine interns on overnight call on depression, burnout, and empathy. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Trial of shift scheduling with standardized sign-out to improve continuity of care in intensive care units. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Impact of Sleep Deprivation on Surgical Laparoscopic Performance in Novices: A Computer-based Crossover Study. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Systematic review: association of shift length, protected sleep time, and night float with patient care, residents' health, and education. [2022]