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Resident Work Schedules for Patient Safety (InCURS Trial)

N/A

Recruiting

Led By Dominique Piquette, MD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admit adult patients (≥18 years);

Are able to perform overnight in-house duty with supervision from critical care trainees and intensivists,

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two days per week at 8am, noon and 4pm during the first 4 weeks of a residents icu rotation

Awards & highlights

InCURS Trial Summary

This trial will compare the effects of two different work-hour schedules for doctors in training ('residents') in Canada.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While this isn't a drug trial with typical side effects, changing shift lengths could impact resident wellbeing (like increased tiredness or burnout), learning effectiveness (ability to manage diseases or perform procedures), patient safety (risk of mistakes due to fatigue), and overall quality of care.

InCURS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can perform overnight duties in a hospital with supervision.

InCURS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two days per week at 8am, noon and 4pm during the first 4 weeks of a residents icu rotation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two days per week at 8am, noon and 4pm during the first 4 weeks of a residents icu rotation

This trial's timeline: 3 weeks for screening, Varies for treatment, and two days per week at 8am, noon and 4pm during the first 4 weeks of a residents icu rotation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Patient Mortality After Index ICU Admission (First ICU Admission within the study periods)

Resident Burnout - Emotional Exhaustion

Resident Cognitive Reasoning-Script Concordance Test

Secondary outcome measures

Rate of ICU Mortality

Rate of Medication Error

Rate of Patient Adverse Events

+8 more

Other outcome measures

Amount of Sleep in last 12 hours.

Duration of Resident sleep

ICU Resource Utilization: Duration of Acute dialysis

+23 more

InCURS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 16 hour scheduleExperimental Treatment2 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 scheduleActive Control2 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).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreOTHER

656 Previous Clinical Trials

1,551,288 Total Patients Enrolled

2 Trials studying Education

94 Patients Enrolled for Education

The Hospital for Sick ChildrenLead Sponsor

690 Previous Clinical Trials

6,945,458 Total Patients Enrolled

1 Trials studying Education

456 Patients Enrolled for Education

Dominique Piquette, MDPrincipal InvestigatorSunnybrook Health Sciences Centre

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the recruitment period for this medical experiment been concluded?

"This clinical trial, first posted back on November 18th 2019, is currently not recruiting patients as reported by clinicialtrials.gov. Nevertheless, there are 40 other trials that are actively seeking volunteers at this time."

Answered by AI

What are the overarching aims of this research endeavor?

"The primary outcome of this trial, monitored for up to 90 days following ICU admission, is Resident Cognitive Reasoning-Script Concordance Test. Secondary objectives include Resident Procedural Competencies: Basic Airway Management (assessed using the Objective Structured Assessment of Technical Skills Global Rating Scale; 1 indicating lowest performance and 5 highest), Resident Communication Competency (measured through Analytic Global Rating Scale with domains like empathy & verbal expression; 1 being least proficient and 5 most adept) and lastly, Resident Nighttime Sleepiness assessed by Stanford Sleepiness Scale from 1 to 7 or an 8th response if asleep at time of assessment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intensive Care Unit Resident Scheduling Trial

Christopher Parshuram 2019. "Intensive Care Unit Resident Scheduling Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04176094.