Patient SafetyNCT01398878
Assessing the Impact of a Change to the Work Schedule of Resident Physicians: a Mixed Methods Study
A study testing Intervention work shift in people with Patient Safety and Resident Work Hours, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Safety, Resident Work Hours
- What is being tested?
- Intervention work shift
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St Paul's Hospital
Vancouver, British Columbia, V6Z1Y6
Najib Ayas, MD MPH, 604-806-9420, Nayas@providencehealth.bc.ca
Najib Ayas, MD MPH
About this study
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.
- Conditions
- Patient Safety, Resident Work Hours
- Being tested
- Intervention work shift
- Keywords
- Medical education, graduate, Patient care, Outcome assessment (Health care), Work schedule tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention work shiftBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Traditional work schedule | No intervention | Residents in the intensive care unit perform overnight shifts in excess of 24 hrs every fourth night |
| Intervention work schedule | Active comparator | Residents in the Intensive Care Unit perform shifts less than 16 hours in length and have at least 8 hours off between shifts Receives: Behavioral: Intervention work shift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventable adverse events
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.
Measured: 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 outcomes (10)
Quantity of scheduled and unscheduled learning activities residents participate in
Assessed by review of sleep/activity log
Measured: End of each 28 day rotation
Resident leisure time, sleep, and time spent in the hospital
Assessed by review of sleep/activity log
Measured: End of each 28 day rotation
Professionalism
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.
Measured: End of each 28 day rotation
Nursing impact
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.
Measured: Over course of study (12 months)
Attending physician workload
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.
Measured: Over course of study (12 months)
Perceived continuity of care
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.
Measured: Over course of study (12 months)
Quality of life
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.
Measured: End of each 28 day rotation
Resident knowledge acquisition and retention
Scores on validated multiple choice question exams
Measured: End of each 28 day rotation
Patient satisfaction
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.
Measured: Within two weeks of ICU discharge
Job satisfaction/Stress
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.
Measured: End of each 28 day rotation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Michael Smith Foundation
- Investigators
- Najib Ayas, MD MPH, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398878
- Sponsor's protocol ID
- H09-02007
- Status last verified
- Jul 2011
- First submitted
- 11 Jul 2011
- Last updated
- 25 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of a Change to the Work Schedule of Resident Physicians: a Mixed Methods Study
- ClinicalTrials.gov ID
- NCT01398878
- Acronym / sponsor ID
- H09-02007
- Conditions
- Patient Safety, Resident Work Hours
- Keywords
- Medical education, graduate, Patient care, Outcome assessment (Health care), Work schedule tolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Michael Smith Foundation
- Study start
- Jul 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 21 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional work schedule | No intervention | –Residents in the intensive care unit perform overnight shifts in excess of 24 hrs every fourth night |
| Intervention work schedule | Active comparator | Behavioral: Intervention work shiftResidents in the Intensive Care Unit perform shifts less than 16 hours in length and have at least 8 hours off between shifts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention work shiftShiftwork 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 | Behavioural | Intervention work schedule |
Primary outcome
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.
10 secondary outcomes
Quantity of scheduled and unscheduled learning activities residents participate in
Time frame: End of each 28 day rotation
Resident leisure time, sleep, and time spent in the hospital
Time frame: End of each 28 day rotation
Professionalism
Time frame: End of each 28 day rotation
Nursing impact
Time frame: Over course of study (12 months)
Attending physician workload
Time frame: Over course of study (12 months)
Perceived continuity of care
Time frame: Over course of study (12 months)
Quality of life
Time frame: End of each 28 day rotation
Resident knowledge acquisition and retention
Time frame: End of each 28 day rotation
Patient satisfaction
Time frame: Within two weeks of ICU discharge
Job satisfaction/Stress
Time frame: End of each 28 day rotation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Najib Ayas, MD MPH principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention work shift in people with Patient Safety and Resident Work Hours, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Najib Ayas, MD MPH (604-806-9429, NAyas@providencehealth.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2011.