Intensive Care Unit Resident Scheduling Trial

NCT04176094 | Recruiting DMC

• 1 other identifier: 1744
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

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.

Conditions

Patient Safety; Well-being; Education

Keywords

health service and systems research; population health

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• 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 Procedural Competencies: Central Venous Line

  Week 4 of ICU rotation

Other Outcomes (26)

• Rate of Patient ICU Re-admission

  48 hours post-ICU discharge

• Rate of Patient Treated Cardiac Arrest

  During ICU stay and up to 3 days post ICU discharge

• Rate of Patient Bleeding

  During ICU stay and up to 3 days post ICU discharge

Study Arms (2)

16 hour schedule

EXPERIMENTAL

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; Other: Handover training

24 hour schedule

ACTIVE COMPARATOR

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; Other: Handover training

Interventions

16h overnight duty OTHER

schedule observed by participating ICUs.

16 hour schedule

24h overnight duty OTHER

schedule observed by participating ICUs.

24 hour schedule

Handover training OTHER

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.

16 hour schedule; 24 hour schedule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Patients admitted to ICU during either period of the study.
• 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.
• Are Physicians responsible for the supervision of residents and other trainees in the ICU, and include Critical Care Trainees and Staff Physicians.
• Are Registered nurses, registered respiratory therapists, pharmacists, social workers, physiotherapists and occupational therapists, who provide care in the ICU.

You may not qualify if:

• 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.
• Patients will be excluded if they are in the ICU at the start of a study period.
• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (5)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

COMPLETED

St Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

COMPLETED

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

COMPLETED

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

COMPLETED

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Related Publications (1)

• Parshuram CS, Amaral AC, Ferguson ND, Baker GR, Etchells EE, Flintoft V, Granton J, Lingard L, Kirpalani H, Mehta S, Moldofsky H, Scales DC, Stewart TE, Willan AR, Friedrich JO; Canadian Critical Care Trials Group. Patient safety, resident well-being and continuity of care with different resident duty schedules in the intensive care unit: a randomized trial. CMAJ. 2015 Mar 17;187(5):321-9. doi: 10.1503/cmaj.140752. Epub 2015 Feb 9.

  PMID: 25667258 BACKGROUND

Study Officials

• Chris Parshuram, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Dominique Piquette, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weeda Zabih

CONTACT

416-813-7654; weeda.zabih@sickkids.ca

Jordan Dang

CONTACT

416-813-7654; jordan.dang@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A cluster-randomized crossover trial will compare 16h vs. 24h overnight schedules for residents completing an ICU rotation.

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: November 25, 2019
• Study Start: November 18, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)