FatigueNCT00679809
Safety, Fatigue, and Continuity in the Intensive Care Unit (ICU)
An observational study of Fatigue, run by The Hospital for Sick Children at 3 sites in Canada.
Trial summary
The purpose of this study is to describe the features of continuity and quantify fatigue in three ICU resident work schedules, estimate the frequency of preventable adverse events, and inform the design and demonstrate the feasibility of a future multi-centre study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fatigue
- How many people
- 19 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 2008to Dec 2013
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Residents will be on their 2-month ICU rotations at one of two university affiliated hospitals in Toronto medical-surgical ICU. Residents in these ICU rotations are from internal medicine, surgery, emergency medicine and anesthesia training programs, and are supported by 2-3 critical care fellows, and 1 staff physician
Who may be able to join
- All residents at participating ICUs starting a rotation in Fall 2008
- Staff members supervising and/or working with participating residents
- Patients/family members under the care of the participating residents
- Patients admitted to participating ICUs
Who cannot join
- Lack of informed consent
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Mount Sinai Hospital
Toronto, Ontario
St Michael's Hospital
Toronto, Ontario
The Hospital for Sick Children
Toronto, Ontario
About this study
Official title: Safety, Fatigue, and Continuity in the ICU: a Pragmatic Mixed-methods Study
The purpose of this study is to describe the features of continuity and quantify fatigue in three ICU resident work schedules, estimate the frequency of preventable adverse events, and inform the design and demonstrate the feasibility of a future multi-centre study.
Read the detailed description
The overall goal of our research is to describe the optimal scheduling pattern for frontline physicians working in ICUs. Our hypothesis is that call schedule associated reductions in fatigue are counterbalanced by reductions in continuity, resulting in no change in the safety of patients.
This is a prospective before-after, two-centre study using a mixed-methods design. We will apply 3 work schedules, each for a period of 2 months over a 6 month period in the adult medical-surgical ICUs at two university affiliated hospitals in Toronto. In this mixed methods approach, quantitative and qualitative data will be collected concurrently, analysed separately, and their results compared, to produce an integrated interpretation of the impact of work schedule on the relationship between continuity and fatigue.
This will evaluate healthcare continuity and fatigue, describe adverse events in ICUs, identify the two best resident schedules for subsequent comparison, and demonstrate the feasibility of a future multi-centre study of physician scheduling.
- Conditions
- Fatigue
- Keywords
- Resident, Safety, Fatigue, Continuity, ICU
- Medical subject headings
- Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Measured: 6 months
Continuity of patient care
Measured: 6 months
Secondary outcomes (3)
Adverse events
Measured: 6 months
Preventable adverse events
Measured: 6 months
Feasibility
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startOct 2008
- Primary completionJul 2009
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Parshuram, The Hospital for Sick Children
- Investigators
- Chris Parshuram, MBChB, PhD, Principal investigator, The Hospital for Sick ChildrenJan Friedrich, MD, Principal investigator, Unity Health TorontoThomas Stewart, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679809
- Sponsor's protocol ID
- 1000011945
- Status last verified
- May 2015
- First submitted
- 15 May 2008
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25667258
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Fatigue, and Continuity in the ICU: a Pragmatic Mixed-methods Study
- ClinicalTrials.gov ID
- NCT00679809
- Acronym / sponsor ID
- 1000011945
- Conditions
- Fatigue
- Keywords
- Resident, Safety, Fatigue, Continuity, ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 May 2008 (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 describe the features of continuity and quantify fatigue in three ICU resident work schedules, estimate the frequency of preventable adverse events, and inform the design and demonstrate the feasibility of a future multi-centre study.
Detailed description
The overall goal of our research is to describe the optimal scheduling pattern for frontline physicians working in ICUs. Our hypothesis is that call schedule associated reductions in fatigue are counterbalanced by reductions in continuity, resulting in no change in the safety of patients.
This is a prospective before-after, two-centre study using a mixed-methods design. We will apply 3 work schedules, each for a period of 2 months over a 6 month period in the adult medical-surgical ICUs at two university affiliated hospitals in Toronto. In this mixed methods approach, quantitative and qualitative data will be collected concurrently, analysed separately, and their results compared, to produce an integrated interpretation of the impact of work schedule on the relationship between continuity and fatigue.
This will evaluate healthcare continuity and fatigue, describe adverse events in ICUs, identify the two best resident schedules for subsequent comparison, and demonstrate the feasibility of a future multi-centre study of physician scheduling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents will be on their 2-month ICU rotations at one of two university affiliated hospitals in Toronto medical-surgical ICU. Residents in these ICU rotations are from internal medicine, surgery, emergency medicine and anesthesia training programs, and are supported by 2-3 critical care fellows, and 1 staff physician
Key inclusion criteria (4 listed)
- All residents at participating ICUs starting a rotation in Fall 2008
- Staff members supervising and/or working with participating residents
- Patients/family members under the care of the participating residents
- Patients admitted to participating ICUs
Key exclusion criteria (1 listed)
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatigue
Time frame: 6 months
Continuity of patient care
Time frame: 6 months
3 secondary outcomes
Adverse events
Time frame: 6 months
Preventable adverse events
Time frame: 6 months
Feasibility
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Derived from this study: PubMed 25667258Parshuram 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.
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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.
Chris Parshuram, MBChB, PhD principal investigator
The Hospital for Sick Children
Jan Friedrich, MD principal investigator
Unity Health Toronto
Thomas Stewart, MD principal investigator
MOUNT SINAI HOSPITAL
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue, run by The Hospital for Sick Children at 3 sites 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 4 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: finished, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00679809, which also lists 1 linked publication.
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 1 Jun 2015.