Intensive Care Unit Resident Scheduling Trial

ConditionsPatient Safety Well-being Education

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorThe Hospital for Sick Children

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

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),

Disqualifiers

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.

Residents enrolled in a critical care medicine accredited specialty training program,

Trial design

Design model

Crossover

Treatments tested in this trial

16h overnight duty
Other intervention
schedule observed by participating ICUs.
24h overnight duty
Other intervention
schedule observed by participating ICUs.
Handover training
Other intervention
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.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: 16 hour scheduleExperimental treatment 2 interventions

Group B: 24 hour scheduleActive comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

4th week of ICU rotation

Secondary outcomes

Rate of ICU Mortality

Patient death occurring during ICU admission.

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

During 4th week of ICU rotation

Other outcomes

Rate of Patient ICU Re-admission

Patient ICU Re-admission within 48hrs of ICU discharge.

Time frame

48 hours post-ICU discharge

Rate of Patient Treated Cardiac Arrest

Documented cessation of circulation. Cardiac compressions and/or defibrillation provided in the ICU. The measurement tool used is a study specific case report form (CRF).

Time frame

During ICU stay and up to 3 days post ICU discharge

Rate of Patient Bleeding

Major new bleed with laboratory evidence and requiring transfusion. Clinically important minor new bleed (not requiring transfusion). The measurement tool used is a study specific case report form (CRF).

Time frame

During ICU stay and up to 3 days post ICU discharge

Rate of Patient Thrombosis/Embolism

New, documented thrombosis or embolism confirmed with imaging. The measurement tool used is a study specific case report form (CRF).

Time frame

During ICU stay and up to 3 days post ICU discharge