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

May 18, 2018 updated by: Rebekah Haylett, Oxford University Hospitals NHS Trust

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

57

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

      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe 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

Patients admitted to ICU after multiple trauma

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WHODAS 2.0 completion rate
Time Frame: 2 days
Number of questionnaires completed/returned on admission to ICU
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to questionnaire completion rate
Time Frame: 2 days
The time taken (hours) from ICU admission to complete the questionnaire
2 days
WHODAS 2.0 completion rate
Time Frame: 6 months post ICU discharge
Number of questionnaires completed/returned at 6 months post ICU discharge
6 months post ICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

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 (Actual)

November 1, 2016

Primary Completion (Actual)

May 5, 2018

Study Completion (Actual)

May 5, 2018

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimate)

September 28, 2016

Study Record Updates

Last Update Posted (Actual)

May 21, 2018

Last Update Submitted That Met QC Criteria

May 18, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 209899

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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