Effects of Advanced Trauma Life Support Training Compared to Standard Care on Adult Trauma Patient Outcomes A Cluster Randomised Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4,320
- 试验地点
- 5
- 主要终点
- The primary outcome will be all-cause mortality.
研究概览
简要总结
Title: Effects of Advanced Trauma Life Support ® Training Compared to Standard Care on Adult Trauma Patient Outcomes: A Cluster Randomised Trial
**Rationale:**Trauma is a massive global health issue. Many training programmes have been developed to help physicians in the initial management of trauma patients. Among these programmes, Advanced Trauma Life Support® (ATLS®) is the most popular, having trained over one million physicians worldwide. Despite its widespread use, there are no controlled trials showing that ATLS® improves patient outcomes. Multiple systematic reviews emphasise the need for such trials.
**Aim:**To compare the effects of ATLS® training with standard care on outcomes in adult trauma patients.
**Primary Outcome:**All-cause mortality within 30 days of arrival at the emergency department.
**Trial Design:**Batched stepped-wedge cluster randomised trial in India.
**Trial Population:**Adult trauma patients presenting to the emergency department of a participating hospital.
**Sample Size:**30 clusters and 4320 patients.
Eligibility Criteria
Hospitals are secondary or tertiary hospitals in India that admit or refer/transfer for admission at least 400 patients with trauma per year.
Clusters are one or more units of physicians providing initial trauma care in the emergency department of tertiary hospitals in India.
Patients participants are adult trauma patients who presents to the emergency department of participating hospitals and are admitted or transferred for admission.
Intervention: The intervention will be ATLS ® training, a proprietary 2.5 day course teaching a standardised approach to trauma patient care using the concepts of a primary and secondary survey. Physicians will be trained in an accredited ATLS ® training facility in India.
Ethical Consideration:s We will use an opt-out consent approach for collection of routinely recorded data. We will obtain informed consent for collection of non-routinely recorded data, such as quality of life and disability outcomes. Patients who are unconscious or lack a legally authorized representative will be included under a waiver of informed consent. Note that consent here refers to consent to data collection.
**Trial Period:**2024 to 2029
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age of at least 15 years.
- •Present to the emergency department of participating hospitals with a history of trauma defined as having any of the reasons listed in the International Classification of Diseases chapter XX as the reason for presenting.
- •Admitted or died between arrival at the hospital and admission, or referred/transferred from the emergency department of a participating hospital to another hospital for admission.
- •Trauma occurred less than 48 hours before arrival at the hospital.
排除标准
- •Patients participants are excluded if they meet the following criteria: 1) present with isolated limb injuries; or 2) are directly admitted to a ward without being seen by a physician in the emergency department.
结局指标
主要结局
The primary outcome will be all-cause mortality.
时间窗: within 30 days of arrival at the emergency department.
次要结局
- All-cause mortality(within 24 hours and 3 months of arrival at the emergency department.)
- In-hospital mortality(within 30 days of arrival at the emergency department.)
- Quality of life (EQ5D3L)(within 7 days of discharge, and at 30 days and 3 months of arrival at the emergency department.)
- WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)(within 7 days of discharge, and at 30 days and 3 months of arrival at the emergency department.)
- Return to work(30 days and 3 months after arrival at the emergency department.)
- Length of emergency department stay(Data on this outcome will be collected from patient hospital records.)
- Length of hospital stay(Data on this outcome will be collected from patient hospital records.)
- Intensive care unit admission(Data on this outcome will be collected from patient hospital records.)
- Length of intensive care unit stay(Data on this outcome will be collected from patient hospital records.)
研究者
Dr Vivekanand Jha
The George Institute for Global Health, India