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

Multiple Trauma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02917694
• Other study ID #: 209899
• Status: Completed
• Start date: November 1, 2016
• Est. completion date: May 5, 2018

Study information

• Verified date: May 2018
• Source: Oxford University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 5, 2018
• Est. primary completion date: May 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WHODAS 2.0 completion rate	Number of questionnaires completed/returned on admission to ICU	2 days
Secondary	Time to questionnaire completion rate	The time taken (hours) from ICU admission to complete the questionnaire	2 days
Secondary	WHODAS 2.0 completion rate	Number of questionnaires completed/returned at 6 months post ICU discharge	6 months post ICU discharge