Multiple TraumaNCT02917694
A Feasibility Study to Assess Pre Admission Status and Six Month Outcomes After Major Trauma
An observational study of Multiple Trauma, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study aims to assess the feasibility of obtaining details about a patients previous level of function from the patient of friend/relative, after they have been admitted an intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Trauma
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2016to 5 May 2018
- 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: Patients admitted to ICU after multiple trauma
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study
- Participants relative or friend (consultee) is willing and able to give informed consent for participation in the study (where the patient is unable to give informed consent)
- Male or Female, aged 18 years or above
- Injury Severity Score greater than 9
- Admitted as an emergency to AICU
- Experienced at least 24 hours level three care during their admission
Who cannot join
- Non UK resident (due to potential loss to follow up)
- Unwilling to consent
- No GP details available
- Patients with a palliative diagnosis or established on a palliative treatment pathway
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study to Assess Pre Admission Status and Six Month Outcomes of Major Trauma Patients Admitted to an Intensive Care Unit, Using the WHO DAS 2.0.
This study aims to assess the feasibility of obtaining details about a patients previous level of function from the patient of friend/relative, after they have been admitted an intensive care unit (ICU). It will also assess the feasibility of re-assessing level of function at 6 months after the patient has been discharged from ICU.
Read the detailed description
Currently there is no standardised way of obtaining details about a patients pre-admission level of function. the process of gaining this history is often done by several different people with no standard questions asked.
There is also a need to be able to measure what happens to patients after they leave ICU, and compare their abilities to preadmission status.
This feasibility study will aim to investigate:
- the time taken to train the physiotherapy team in the use of the outcome measure
- the ability to obtain pre admission functional status from patients/friend/relative on admission to ICU
- the ability to follow patients up at 6 months post discharge with re-assessment of the outcome measure
- Conditions
- Multiple Trauma
- Medical subject headings
- Multiple Trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
WHODAS 2.0 completion rate
Number of questionnaires completed/returned on admission to ICU
Measured: 2 days
Secondary outcomes (2)
Time to questionnaire completion rate
The time taken (hours) from ICU admission to complete the questionnaire
Measured: 2 days
WHODAS 2.0 completion rate
Number of questionnaires completed/returned at 6 months post ICU discharge
Measured: 6 months post ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start1 Nov 2016
- Primary completion5 May 2018
- Study completion5 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple TraumaStudies of the same condition, open and under way.
- 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebekah Haylett, Oxford University Hospitals NHS Trust
- Investigators
- Rebekah Haylett, BSc (Hons), Principal investigator, Oxfod University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917694
- Sponsor's protocol ID
- 209899
- Status last verified
- May 2018
- First submitted
- 26 Sep 2016
- Last updated
- 21 May 2018
- 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 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Assess Pre Admission Status and Six Month Outcomes of Major Trauma Patients Admitted to an Intensive Care Unit, Using the WHO DAS 2.0.
- ClinicalTrials.gov ID
- NCT02917694
- Acronym / sponsor ID
- 209899
- Conditions
- Multiple Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 5 May 2018 (actual)
- Study completion
- 5 May 2018 (actual)
- First posted
- 28 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 aims to assess the feasibility of obtaining details about a patients previous level of function from the patient of friend/relative, after they have been admitted an intensive care unit (ICU). It will also assess the feasibility of re-assessing level of function at 6 months after the patient has been discharged from ICU.
Detailed description
Currently there is no standardised way of obtaining details about a patients pre-admission level of function. the process of gaining this history is often done by several different people with no standard questions asked.
There is also a need to be able to measure what happens to patients after they leave ICU, and compare their abilities to preadmission status.
This feasibility study will aim to investigate:
- the time taken to train the physiotherapy team in the use of the outcome measure
- the ability to obtain pre admission functional status from patients/friend/relative on admission to ICU
- the ability to follow patients up at 6 months post discharge with re-assessment of the outcome measure
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to ICU after multiple trauma
Key inclusion criteria (6 listed)
- Participant is willing and able to give informed consent for participation in the study
- Participants relative or friend (consultee) is willing and able to give informed consent for participation in the study (where the patient is unable to give informed consent)
- Male or Female, aged 18 years or above
- Injury Severity Score greater than 9
- Admitted as an emergency to AICU
Key exclusion criteria (4 listed)
- Non UK resident (due to potential loss to follow up)
- Unwilling to consent
- No GP details available
- Patients with a palliative diagnosis or established on a palliative treatment pathway
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
WHODAS 2.0 completion rate
Time frame: 2 days
Number of questionnaires completed/returned on admission to ICU
2 secondary outcomes
Time to questionnaire completion rate
Time frame: 2 days
WHODAS 2.0 completion rate
Time frame: 6 months post ICU discharge
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 21 May 2018.
- 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.
Rebekah Haylett, BSc (Hons) principal investigator
Oxfod University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Trauma, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
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 6 inclusion and 4 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 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
WHODAS 2.0 completion rate (time frame: 2 days). 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 21 May 2018; AzTrials last refreshed its copy on 6 Nov 2026.