Safety, Fatigue, and Continuity in the Intensive Care Unit (ICU)

May 28, 2015 updated by: Christopher Parshuram, The Hospital for Sick Children

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

19

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada
        • The Hospital for Sick Children
      • Toronto, Ontario, Canada
        • St Michael's Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fatigue
Time Frame: 6 months
6 months
Continuity of patient care
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 6 months
6 months
Preventable adverse events
Time Frame: 6 months
6 months
Feasibility
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Chris Parshuram, MBChB, PhD, The Hospital for Sick Children
  • Principal Investigator: Jan Friedrich, MD, Unity Health Toronto
  • Principal Investigator: Thomas Stewart, MD, Mount Sinai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 15, 2008

First Submitted That Met QC Criteria

May 16, 2008

First Posted (Estimate)

May 19, 2008

Study Record Updates

Last Update Posted (Estimate)

June 1, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000011945

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.

Clinical Trials on Fatigue

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe