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MaTOMS: A Feasibility Study Into Collecting Major Trauma Outcomes (MaTOMS)

2017年9月6日 更新者:Liz Tutton、Oxford University Hospitals NHS Trust

MaTOMS: A Feasibility Study Into the Validity and Acceptability of Routine Collection of Outcome Data in Major Trauma Patients in a Major Trauma Centre in England

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.

研究概览

详细说明

Purpose and design

Historically much of the literature into major trauma refers to outcomes and mortality synonymously. However there is a growing recognition that as trauma systems mature and more patients lives are saved, the focus has to shift from amenable mortality to improving patient morbidity. Other than mortality it is not currently possible to ascertain the outcomes of patients with major trauma in England as there is no international consensus on which outcome measures should be collected for major trauma patients, nor a collection process in place.

Patients who suffer major trauma are often left with significant long term morbidity with one paper suggesting 42% are unable to return to work at 1 year and another suggesting full recovery is only present in 30% at 5 years. It is important for patients and the public that any outcome measures that are implemented can allow the identification of good or inadequate treatment so that attention can be addressed to improving the quality of care. None of these exist at present and this feasibility study aims to help identify and develop these for possible national implementation.

The study is designed as an observational feasibility study as the way outcomes will be assessed is via a structured interview either face to face or by telephone made up of questions from existing outcome measure instruments and the practicalities of collection of data and identification of the best instruments need to be made prior to any larger study. The instruments have been chosen from those that are known to measure outcomes in one or more domains of the World Health Organisation International Classification of Functioning, Disability and Health (WHO ICF) and that have been previously used to measure outcome in major trauma patients in the literature and have been recommended by a workshop of clinicians and other stakeholders.

The study is designed as an observational feasibility study as the way outcomes will be assessed is via a structured interview either face to face or by telephone made up of questions from existing outcome measure instruments and the practicalities of collection of data and identification of the best instruments need to be made prior to any larger study. The instruments have been chosen from those that are known to measure outcomes in one or more domains of the World Health Organisation International Classification of Functioning, Disability and Health (WHO ICF) and that have been previously used to measure outcome in major trauma patients in the literature and have been recommended by a workshop of clinicians and other stakeholders.

The design of the study has been influenced by existing protocols by which major trauma patients are routinely followed up in Victoria State in Australia. The main difference is that whilst the Australian protocols involved optout consent, this study will involve informed consent or in the case of those who are unable to consent, their Consultee (either personal or nominated) will be asked to advise whether they think the patient would be content to participate. Children aged 2 or more will be included in this study with their parents providing informed consent.

This study will build on the current literature as it will allow the assessment of the feasibility of assessing outcomes in an English Major Trauma Centre and the identification of the most suitable instruments. The study will also measure each instruments and their validity & sensitivity to change and allow an estimation of the costs and other logistics surrounding the routine collection of this data in England to be made.

研究类型

观察性的

注册 (实际的)

70

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Oxford、英国、OX3 9DU
        • Oxford University Hospital Trust

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

2年 及以上 (孩子、成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
EQ-5D
大体时间:12 months
Quality of life
12 months

次要结果测量

结果测量
措施说明
大体时间
SF12
大体时间:12 months
Quality of Life
12 months
GOS-E
大体时间:12 months
Function
12 months
FIM
大体时间:12 months
Function
12 months
Pain Score
大体时间:12 months
Likert scale
12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Keith Willett、Oxford University Hospital Trust

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2013年4月1日

初级完成 (实际的)

2016年5月1日

研究完成 (实际的)

2016年10月1日

研究注册日期

首次提交

2015年1月21日

首先提交符合 QC 标准的

2017年9月6日

首次发布 (实际的)

2017年9月11日

研究记录更新

最后更新发布 (实际的)

2017年9月11日

上次提交的符合 QC 标准的更新

2017年9月6日

最后验证

2017年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 12/SC/0628

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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