MaTOMS: A Feasibility Study Into Collecting Major Trauma Outcomes

NCT03277560 | Completed DMC

• 1 other identifier: 12/SC/0628
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Major Trauma Outcome Measures Study (MaTOMS): A feasibility Study into using outcome measures in major trauma patients. At present patients who suffer major trauma (multiple, serious injuries that could result in death or serious disability e.g. serious head injuries and multiple fractures), are now able to survive due to advances in modern medicine. Unfortunately they may be left with long term disabilities such as problems with performing day to day activities. We currently do not know how bad these disabilities are or have any way of judging any differences between the outcomes of different hospitals. MaTOMS is a feasibility study taking place in one hospital, the John Radcliffe Hospital which aims to help answer these questions by developing a set of structured interviews that can be used after an injury to find out about patient outcomes. It will identify how difficult or easy it is to collect the data and information outlined in this project, and whether the types of data and information collected as part of the interviews are a good indicator of a patient's outcomes. Over 30 months the study will recruit up to 100 patients who are aged 2 years and over who have been admitted following major trauma. Major trauma will be defined as a score of 9 or more on the Injury Severity Score, a widely used system to stratify those who suffer an injury. Those who agree to take part following a consent process will undergo structured interviews both in hospital and twice via telephone in the year following discharge. Some participants will take part in an additional interview either asking about their experience of answering the questions during the structured interview or exploring their experience and feelings about their traumatic injury to see if our structured interviews are missing any aspect of their experience. The main objectives for this feasibility study is to test the feasibility of routine collection of outcome measurement data following major trauma.

Conditions

Trauma

Keywords

Major Trauma Centre; ISS; Outcome Measures

Outcome Measures

Primary Outcomes (1)

• EQ-5D

  Quality of life

  12 months

Secondary Outcomes (4)

• SF12

  12 months

• GOS-E

  12 months

• FIM

  12 months

• Pain Score

  12 months

Interventions

No Intervention as it is an observational study OTHER

No Intervention as it is an observational study

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients aged 2 or over who are admitted to the study centre with a diagnosis that is encompassed by the definition of major trauma (Injury Severity Score greater than or equal to 9) following injury will be eligible for the study as long as they are enrolled less than 4 weeks following the injury and consent to participate.

You may qualify if:

• Male or female
• Over 2 years
• First admission (for a particular set of injuries) to the Major Trauma Centre
• Traumatic injuries with ISS 9 or more as estimated at time of eligibility assessment
• Within 4 weeks of injury

You may not qualify if:

• The participant may not enter the study if ANY of the following apply:
• Non resident in the United Kingdom
• Patient unwilling to give informed consent
• Patient unable to give informed consent and 'consultee' advises they feel patient would not be content to participate
• Inmate in prison and therefore unable to be easily followed up by telephone

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

Oxford University Hospital Trust

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Keith Willett

  Oxford University Hospital Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: September 11, 2017
• Study Start: April 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

GB (1)