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Completed

NCT Number: NCT02917694

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. WHODAS 2.0 completion rate

    Time frame: 2 days

    Number of questionnaires completed/returned on admission to ICU

Secondary outcomes

  1. Time to questionnaire completion rate

    Time frame: 2 days

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

  2. WHODAS 2.0 completion rate

    Time frame: 6 months post ICU discharge

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

Sponsors and collaborators

Lead sponsor

Oxford University Hospitals NHS Trust

Other

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 28, 2016
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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