- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01398878
Assessing the Impact of a Change to the Work Schedule of Resident Physicians: a Mixed Methods Study
July 22, 2011 updated by: University of British Columbia
The purpose of this study is to determine the impact of eliminating traditional resident work shifts (i.e.
greater than 24 hours in length) on patient safety and resident educational outcomes.
In addition, the investigators will explore with key stakeholders (patients and their families, nurses, resident physicians and attending physicians) their experiences when residents are undertaking shifts greater than 24 hours in length as compared to 16 hours or less.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6Z1Y6
- Recruiting
- St Paul's Hospital
-
Contact:
- Najib Ayas, MD MPH
- Phone Number: 604-806-9420
- Email: Nayas@providencehealth.bc.ca
-
Principal Investigator:
- Najib Ayas, MD MPH
-
Sub-Investigator:
- Adam Peets, MD MSc
-
Sub-Investigator:
- Peter Dodek, MD MHSc
-
Sub-Investigator:
- Natalie Henrich, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Residents completing Intensive Care Unit rotations
- For focus groups and interviews, patients and families members admitted during the study period and nurses and attending physicians working during the study period
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Traditional work schedule
Residents in the intensive care unit perform overnight shifts in excess of 24 hrs every fourth night
|
|
|
Active Comparator: Intervention work schedule
Residents in the Intensive Care Unit perform shifts less than 16 hours in length and have at least 8 hours off between shifts
|
Shiftwork schedule with elimination of shifts greater than 16 hours in length and at least 8 hours off between shifts for all residents in the Intensive Care Unit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preventable adverse events
Time Frame: Occurring during course of ICU admission and within first 72 hours of ICU discharge if event is attributable to process of care in the ICU
|
The primary outcome is the rate of preventable adverse events per 1000 patient days.
An adverse event will be defined as any unplanned injury arising as a consequence of medical care that is associated with morbidity, requires treatment, prolongs hospital stay, or results in disability at discharge.
Adverse events are not caused by the disease process itself, but do include any procedural or therapeutic complications.
Preventable adverse events will be defined as those adverse events that could have been avoided given current knowledge and standards of care.
|
Occurring during course of ICU admission and within first 72 hours of ICU discharge if event is attributable to process of care in the ICU
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantity of scheduled and unscheduled learning activities residents participate in
Time Frame: End of each 28 day rotation
|
Assessed by review of sleep/activity log
|
End of each 28 day rotation
|
|
Resident leisure time, sleep, and time spent in the hospital
Time Frame: End of each 28 day rotation
|
Assessed by review of sleep/activity log
|
End of each 28 day rotation
|
|
Professionalism
Time Frame: End of each 28 day rotation
|
In order to further explore this qualitative outcome measure, during structured interviews of residents, attending physicians, nurses and patients and their families, specific questions will be used to probe the perceived level of resident professionalism.
For example, degree of commitment and professional investment in individual patients, and degree of commitment to the profession of medicine.
|
End of each 28 day rotation
|
|
Nursing impact
Time Frame: Over course of study (12 months)
|
In order to further explore this qualitative outcome measure, during focus groups with nurses specific questions will be used to probe the perceived level of impact on nursing.
|
Over course of study (12 months)
|
|
Attending physician workload
Time Frame: Over course of study (12 months)
|
In order to further explore this qualitative outcome measure, during structured interviews of attending physicians specific questions will be used to probe the perceived level of physician workload.
For example, the difference in level of direct involvement in patient care activities (writing notes, performing procedures, etc) between the two schedules.
|
Over course of study (12 months)
|
|
Perceived continuity of care
Time Frame: Over course of study (12 months)
|
In order to further explore this qualitative outcome measure, during structured interviews of residents, attending physicians, nurses and patients and their families, specific questions will be used to probe the perceived level of continuity of care.
|
Over course of study (12 months)
|
|
Quality of life
Time Frame: End of each 28 day rotation
|
In order to further explore this qualitative outcome measure, during structured interviews of residents specific questions will be used to probe the perceived level of quality of life for the different call schedules.
|
End of each 28 day rotation
|
|
Resident knowledge acquisition and retention
Time Frame: End of each 28 day rotation
|
Scores on validated multiple choice question exams
|
End of each 28 day rotation
|
|
Patient satisfaction
Time Frame: Within two weeks of ICU discharge
|
Given the multitude of potential variables that impact patient satisfaction, during the interviews of patients and their families, the following questions will be used to inform the outcome measure: a global assessment of the patient's experience, their satisfaction with the overall care provided by the healthcare team and their satisfaction with their experiences with resident physicians in particular.
|
Within two weeks of ICU discharge
|
|
Job satisfaction/Stress
Time Frame: End of each 28 day rotation
|
In order to further explore this qualitative outcome measure, during structured interviews of residents specific questions will be used to probe the perceived level of job satisfaction and stress for the different call schedules.
|
End of each 28 day rotation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Najib Ayas, MD MPH, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Anticipated)
June 1, 2012
Study Completion (Anticipated)
June 1, 2012
Study Registration Dates
First Submitted
July 11, 2011
First Submitted That Met QC Criteria
July 19, 2011
First Posted (Estimate)
July 21, 2011
Study Record Updates
Last Update Posted (Estimate)
July 25, 2011
Last Update Submitted That Met QC Criteria
July 22, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H09-02007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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