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A Feasibility Study to Assess Pre Admission Status and Six Month Outcomes After Major Trauma

Sponsor
Oxford University Hospitals NHS Trust (Other)
Overall Status
Completed
CT.gov ID
NCT02917694
Collaborator
(none)
57
Enrollment
1
Location
18.1
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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). It will also assess the feasibility of re-assessing level of function at 6 months after the patient has been discharged from ICU.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    57 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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.
    Actual Study Start Date :
    Nov 1, 2016
    Actual Primary Completion Date :
    May 5, 2018
    Actual Study Completion Date :
    May 5, 2018

    Outcome Measures

    Primary Outcome Measures

    1. WHODAS 2.0 completion rate [2 days]

      Number of questionnaires completed/returned on admission to ICU

    Secondary Outcome Measures

    1. Time to questionnaire completion rate [2 days]

      The time taken (hours) from ICU admission to complete the questionnaire

    2. WHODAS 2.0 completion rate [6 months post ICU discharge]

      Number of questionnaires completed/returned at 6 months post ICU discharge

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 John Radcliffe Hospital Oxford United Kingdom OX3 9DU

    Sponsors and Collaborators

    • Oxford University Hospitals NHS Trust

    Investigators

    • Principal Investigator: Rebekah Haylett, BSc (Hons), Oxfod University Hospitals NHS Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rebekah Haylett, Physiotherapist, Oxford University Hospitals NHS Trust
    ClinicalTrials.gov Identifier:
    NCT02917694
    Other Study ID Numbers:
    • 209899
    First Posted:
    Sep 28, 2016
    Last Update Posted:
    May 21, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Wounds and Injuries
    Multiple Trauma

    Study Results

    No Results Posted as of May 21, 2018