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临床试验/NCT03235388
NCT03235388已完成不适用

The Trauma Audit Filters Trial: Does Institutional Implementation of Audit Filters Reduce Mortality in Adult Trauma Patients?

Karolinska Institutet4 个研究点 分布在 1 个国家目标入组 10,143 人开始时间: 2017年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10,143
试验地点
4
主要终点
All cause mortality within 30 days of arrival to participating hospital.

研究概览

简要总结

Audit filters for monitoring trauma care quality are regarded as one of the most essential components of trauma quality improvement programmes; however, there is a paucity of evidence that shows that audit filters are associated with improved outcomes. Therefore, our aim is to assess if institutional implementation of audit filters reduce mortality in adult trauma patients.

详细描述

Survey of the field

Trauma, defined as the clinical entity composed of physical injury and the body's associated response, kills almost five million people each year. This is more than the total number of annual deaths from malaria, tuberculosis, HIV/AIDS, and maternal conditions combined. More than 90% of trauma deaths occur in low and middle income countries (LMIC), and about 30-50% of these deaths have been reported to occur in hospital. Research show that almost 11% of the global burden of disease estimated using disability adjusted life years are due to trauma, and that disability adjusted life years from road traffic trauma has increased by 35% in the last 25 years.

The United Nation now vows to reduce the number of road traffic deaths by 50% by 2020. Although primary prevention will play a major role in achieving this, several international actors, including the World Health Organization (WHO), emphasise the importance of strengthened trauma care. A considerable body of research on the strengthening of trauma care attributes improvements in trauma patient outcomes to the implementation of quality improvement programmes, defined as programmes to improve "health care through monitoring the process of care and measuring outcomes".

For example, a recent single centre study from Australia showed a reduction in in-hospital mortality from 16 to 10% after the implementation of a quality improvement programme. This programme included interventions such as a protocol for trauma team activation, massive transfusion protocols, case reviews and the recording and follow up audit filters. Similarly, research from Thailand and Pakistan show reduced mortality after the implementation of such programmes. Unfortunately the heterogeneity of interventions included in most quality improvement programmes makes it hard to draw conclusions about the impact of individual components.

Despite this heterogeneity, audit filters constitute a common denominator across different quality improvement programmes. Such filters can be defined as "pre-identified variables that are routinely tracked to identify whether accepted standards of care are being met". Hence, audit filters are also referred to as quality indicators or key performance indicators. The concept of audit filters in trauma care originates from the American College of Surgeons guidelines on trauma care . They defined 22 filters and the basic idea was that each filter should represent a "sentinel event" associated with poor patient outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted to participating centres with history of trauma. History of trauma is here defined as having any of the external causes of morbidity and mortality listed in block V01-Y36, chapter XX of the International Classification of Disease version 10 (ICD-10) codebook as reason for admission.

排除标准

  • 未提供

结局指标

主要结局

All cause mortality within 30 days of arrival to participating hospital.

时间窗: 30 days

This outcome will be extracted by the project officer from the patient's record as date and time of death or discharge. If the patient is discharged alive before 30 days of arrival the project officer will call the patient or patient relative 30 days after arrival to hospital to establish the patient's status.

次要结局

  • All cause in-hospital mortality(From arrival to emergency department to discharge from hospital, assessed up to 42 months)
  • Number of hospital free days to day 30(30 days)
  • Quality of life measured using validated translations of the EQ-5D-3L instrument(90 days)
  • Number of items adhered to in the WHO trauma care checklist(At the time the participant arrives to emergency department, assessed up to six hours)
  • All cause mortality within 24 hours of arrival to participating hospital.(24 hours)
  • Number of intensive care unit (ICU) free days to day 30(30 days)
  • All cause mortality within 90 days of arrival to participating hospital.(90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Gerdin

Researcher

Karolinska Institutet

研究点 (4)

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