Clinical trial NCT00679809: Safety, Fatigue, and Continuity in the Intensive Care Unit (ICU)
Official title: Safety, Fatigue, and Continuity in the ICU: a Pragmatic Mixed-methods Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatigue
Keywords: Resident
Safety
Fatigue
Continuity
ICU
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2008-05-19
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Lack of informed consent

Primary outcomes:
measure: Fatigue
timeFrame: 6 months
measure: Continuity of patient care
timeFrame: 6 months
Secondary outcomes:
measure: Adverse events
timeFrame: 6 months
measure: Preventable adverse events
timeFrame: 6 months
measure: Feasibility
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Chris Parshuram, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Jan Friedrich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MOUNT SINAI HOSPITAL
name: Thomas Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.