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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal work schedule for resident doctors in intensive care units (ICUs) in Canada. It compares the effects of 16-hour and 24-hour shifts on patient care and resident well-being. The study will examine patient outcomes such as survival rates and any harm caused during care, as well as residents' learning and levels of tiredness or burnout. Suitable candidates for this study are residents enrolled in specialty training, such as internal or emergency medicine, who can work overnight shifts. The goal is to find a balance that ensures patient safety and enhances doctors' learning.

As an unphased trial, this research provides a unique opportunity to contribute to the improvement of healthcare practices and resident well-being.

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 prior data suggests that these resident work schedules are safe for patients and residents?

Research shows that limiting resident work shifts to 16 hours does not negatively affect patient care or education. Studies have found that the quality of care remains stable with 16-hour shifts. Shorter shifts can help residents feel less tired, although this might not significantly change patient safety.

In contrast, 24-hour shifts have mixed results. Some studies suggest that longer shifts can lead to more mistakes, while others find little difference in patient safety. Evidence indicates that shorter shifts might slightly reduce patient deaths, but the change is not substantial.

Overall, both 16-hour and 24-hour shifts appear safe for patients. Each has its own advantages and disadvantages. The decision between them may depend more on their impact on the well-being and learning of the residents. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it could revolutionize how resident work schedules impact patient safety in the ICU. Unlike traditional 24-hour shifts, the trial is comparing a 16-hour overnight duty schedule, which doesn't involve an additional 8-hour daytime shift. This approach could lead to better-rested residents and potentially improve patient care and safety. By examining these two different scheduling methods, researchers hope to find out if shorter shifts can reduce fatigue and enhance decision-making, ultimately improving outcomes for patients.

What evidence suggests that this trial's schedules could be effective for patient safety and resident wellbeing?

This trial will compare the effects of different resident work schedules on patient safety. Research has shown that limiting doctors' work shifts to 16 hours hasn't clearly improved patient safety. A review found that shorter shifts didn't harm doctors' learning. However, 24-hour shifts, another schedule tested in this trial, might lead to more serious mistakes, even though they seem to keep patients safe and improve doctors' work-life balance. Longer hours could mean doctors know their patients less well. Overall, the evidence is mixed, and more research is needed to understand these trade-offs better. ^{1 2 4 6 7}

Who Is on the Research Team?

Chris Parshuram, MD

Principal Investigator

The Hospital for Sick Children

Dominique Piquette, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3690764/

EFFECT OF THE ACGME 16-HOUR RULE ON ... Overall, the 16-hour duty hour changes appeared to have minimal effects on measures of efficiency and quality of care. Several reasons might explain the net ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2910534/

Effects of Reducing or Eliminating Resident Work Shifts ... In a systematic review, we found that reduction or elimination of resident work shifts exceeding 16 hours did not adversely affect resident education, and was ...

3. ama-assn.org ama-assn.org/education/improve-gme/resident-duty-hour-limits-have-no-effect-patient-safety-new-study

Resident duty-hour limits have no effect on patient safety Limits on the number of hours residents can work in a single shift have made no difference in patient safety outcomes, according to a new study.

4. medrxiv.org medrxiv.org/content/10.1101/2021.08.26.21262689v1.full-text

The Effect of Residents' Working-Hour Restrictions on ... This systematic review will provide evidence regarding the effect of resident physicians' working-hour restrictions on patient safety parameters.

5. psnet.ahrq.gov psnet.ahrq.gov/primer/duty-hours-and-patient-safety

Duty Hours and Patient Safety | PSNet Resident physicians routinely worked 90–100 hours per week, for up to 36 consecutive hours without rest, for the entire duration of residency training.

6. medicine.missouri.edu medicine.missouri.edu/sites/default/files/ajhm/2022_AJHM_April-June_ORIGINAL_ARTICLE.pdf

ORIGINAL ARTICLE Nighttime Resident Supervision and ... attending staffing overnight to ensure high- quality patient care (40.4% and 53.7%, respectively, p = 0.024) and patient safety. (43.0% and 56.8 ...

7. psnet.ahrq.gov psnet.ahrq.gov/issue/patient-safety-resident-well-being-and-continuity-care-different-resident-duty-schedules

Patient safety, resident well-being and continuity of care with ... This randomized controlled trial of different resident shift lengths (12, 16, and 24 hours) sought to examine how duty hours affect patient safety, ...