- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02909231
One-year Patient Reported Outcomes Following Hospitalization for Trauma
December 5, 2017 updated by: Chris Grant, University of Calgary
This study evaluates the three, six, and twelve month patient reported outcomes of people admitted two trauma centres in western Canada over a four month period.
Participants are evaluated using the Trauma Outcome Profile and a custom survey instrument.
Study Overview
Status
Terminated
Conditions
Detailed Description
This study intends to assess patient reported outcomes following discharge from trauma services at the Foothills Medical Centre (FMC) and Vancouver General Hospital (VGH).
The investigators will survey participants with pen-and-paper surveys at three, six and twelve months following discharge from hospital.
The survey instrument being used is the Trauma Outcomes Profile, which has been previously validated in this population, supplemented by a supplemental survey to help further describe resources this population has access to in their recovery.
The results of these surveys will be compared with pre-injury health status, injury types, mechanisms, and discharge medications and treatments.
The investigators anticipate enrolling 500 participants starting in October 2016.
At the conclusion of the study the investigators will have a better understanding of patient reported functional outcomes after trauma and will be better positioned to design trauma rehabilitation systems to service this population.
Study Type
Observational
Enrollment (Actual)
42
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
-
-
Alberta
-
Calgary, Alberta, Canada, T3E 2C6
- Foothills Medical Centre
-
-
British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General 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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All adults admitted to the trauma service at either of the two level I trauma centres in Western Canada (Vancouver General Hospital, Vancouver, BC and Foothills Medical Centre, Calgary, AB) over a four month period.
Description
Inclusion Criteria:
- admitted to the trauma service at VGH or FMC
- Age 18 or older
- resident of Canada
Exclusion Criteria:
- English language literacy
- Impairments in cognition, motor, or communication that limit the ability to complete a paper-based survey
- No fixed address
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
Cohorts and Interventions
Group / Cohort |
---|
Foothills Medical Centre
Patients admitted to the Foothills Medical Centre trauma service (Calgary, AB) over four months.
|
Vancouver General Hospital
Patients admitted to the Vancouver General Hospital trauma service (Vancouver, BC) over four months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medium-term health-related quality of life
Time Frame: Up to one year
|
Assessment at 3, 6 and 12 months using the Trauma Outcomes Profile survey instrument.
|
Up to one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local resource use for trauma patients admitted to hospital
Time Frame: Up to one year
|
Assessment at 3, 6, and 12 months using a custom survey to assess local resource use and perceived needs
|
Up to one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chris Grant, MD, University of Calgary
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
September 1, 2016
Primary Completion (Actual)
December 5, 2017
Study Completion (Actual)
December 5, 2017
Study Registration Dates
First Submitted
September 19, 2016
First Submitted That Met QC Criteria
September 19, 2016
First Posted (Estimate)
September 21, 2016
Study Record Updates
Last Update Posted (Actual)
December 7, 2017
Last Update Submitted That Met QC Criteria
December 5, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB15-1860
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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