Wounds and InjuriesNCT02909231
One-year Patient Reported Outcomes Following Hospitalization for Trauma
An observational study of Wounds and Injuries, run by University of Calgary at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries
- How many people
- 42 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2016to 5 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- admitted to the trauma service at VGH or FMC
- Age 18 or older
- resident of Canada
Who cannot join
- English language literacy
- Impairments in cognition, motor, or communication that limit the ability to complete a paper-based survey
- No fixed address
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Foothills Medical Centre
Calgary, Alberta, T3E 2C6
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
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.
Read the 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.
- Conditions
- Wounds and Injuries
- Keywords
- Patient Outcome Assessment
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Medium-term health-related quality of life
Assessment at 3, 6 and 12 months using the Trauma Outcomes Profile survey instrument.
Measured: Up to one year
Secondary outcomes (1)
Local resource use for trauma patients admitted to hospital
Assessment at 3, 6, and 12 months using a custom survey to assess local resource use and perceived needs
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion5 Dec 2017
- Study completion5 Dec 2017
Why it stopped: Failed to recruit sufficient subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health, University of British Columbia
- Responsible party
- Principal investigator, Chris Grant, University of Calgary
- Investigators
- Chris Grant, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909231
- Sponsor's protocol ID
- REB15-1860
- Status last verified
- Dec 2017
- First submitted
- 19 Sep 2016
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Patient Reported Outcomes Following Hospitalization for Trauma
- ClinicalTrials.gov ID
- NCT02909231
- Acronym / sponsor ID
- REB15-1860
- Conditions
- Wounds and Injuries
- Keywords
- Patient Outcome Assessment
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Failed to recruit sufficient subjects
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health, University of British Columbia
- Study start
- Sep 2016
- Primary completion
- 5 Dec 2017 (actual)
- Study completion
- 5 Dec 2017 (actual)
- First posted
- 21 Sep 2016 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- admitted to the trauma service at VGH or FMC
- Age 18 or older
- resident of Canada
Key exclusion criteria (3 listed)
- English language literacy
- Impairments in cognition, motor, or communication that limit the ability to complete a paper-based survey
- No fixed address
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
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.
1 secondary outcome
Local resource use for trauma patients admitted to hospital
Time frame: Up to one year
Results and safety
The study was stopped early (reason given: Failed to recruit sufficient subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Individual participant dataSharing planned: No
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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 Grant, MD principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Injuries, run by University of Calgary at 2 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: Failed to recruit sufficient subjects). Results are not available in the source record.
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?
Medium-term health-related quality of life (time frame: Up to one year). 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 7 Dec 2017.