Development and Evaluation of a Patient Safety Model Targeting Severe Clinical Deterioration and Safety Awareness in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34,556
- 试验地点
- 8
- 主要终点
- The proportion of patients with severe clinical deterioration in the ED
研究概览
简要总结
Despite systems for early detection of critical illness, 12% of patients in the emergency department develop clinical deterioration with an increased risk of death as a result.
There is a need for a intervention to support the identification and clinical management of patients at risk of clinical deterioration earlier hospitalization. The Cincinnati Children's Hospital has introduced a model that systematically complements systems for early detection of critical illness with the assessment of patient and relatives concern, clinical intuition and concern of the staff. In addition, the model includes formalized organizational processes aimed at systematic review of risk patients and early treatment efforts. Studies from United States indicate that the model can lead to reduction of serious incidental events and increase the staff awareness of the situation. The Cincinnati model is designed for children and has not yet been studied in a controlled study.
Purpose To develop and investigate the impact of a Danish patient safety model. Method A literature review is conducted to identify risk factors that should be included in a model aimed at detecting and managing clinical deterioration. A patient safety model is developed on the basis of the literature review and the Cincinnati model and is tested in a pilot study. In a controlled intervention study, the effect is investigated against severe clinical deterioration. The intervention is carried out at the emergency departments at Horsens Regional Hospital and Viborg Regional Hospital with the regional hospitals in Randers and Herning as control departments.
详细描述
Preventing deterioration in acute patients is of great interest internationally. Studies demonstrate that clinical deterioration can be measured up to 24 hours before a heart arrest or intensive care admission in the vital signs. Therefore, the health services have implemented early warning systems to detect deterioration and critical illness.
Despite the systems, 12% of patients in an emergency department still develop severe clinical deterioration with increased risk of death as a result. Research indicates that the reasons for this may be diverse and further action to support the early identification and treatment of patients at risk of deterioration is needed.
Cincinnati Children's Hospital has introduced a patient safety model to ensure identification and mitigation of patient risk through escalated observation, care and treatment depending on the individual's risk for clinical deterioration. The model includes early warning systems, but as something new, it is supplemented with systematic evaluation of more subjective factors such as staff's clinical gaze and concerns, patient/relatives' concerns, communication problems and high risk therapy.
In an observational study, the Cincinnati Situation Awareness model was found to be associated with a near 50% reduction in unsafe intensive care unit transfers and decrease in severe safety events. However, the model has so far not been evaluated in a controlled study or an adult population.
The study will consist of three substudies; the overall study design is based on a framework for implementation of complex interventions following a four-step-process entailing development, pilot test, evaluation and reporting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Adult somatic patients (≥18 years) admitted to the participating Emergency Departments
排除标准
- •Patients with injuries caused by trauma
- •Patients received with cardiac arrest, as a surgical or medical call (can participate if admitted to the Emergency Department and not directly transferred to the Intensive Care Unit)
- •Patients hospitalized with a psychiatric diagnosis as the primary cause of admission
研究组 & 干预措施
New risk assessment
New risk assesment
干预措施: New risk assessment (Other)
Standard
Standard risk assessment
结局指标
主要结局
The proportion of patients with severe clinical deterioration in the ED
时间窗: Participants will be followed for the length of stay in the Emergency Department, an expected period of 48 hours
Severe clinical deterioration will be measured by the early warning system used in Central Denmark Region based on vital signs collected from medical records. The score is aggregated and the vital signs include respiratory rate, SatO2, systolic blood pressure, pulse, temperature and level of consciousness measured by APVU. The initial deterioration process from score 0-1 will be considered as "no deterioration". Deterioration directly to score 2 and above, or deterioration from score ≥2 and further will be considered severe.
次要结局
- Length of stay at the Intensive Care Unit(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Proportion of 30 day - readmission(Participants will be followed for the duration of 30 days after the hospital stay)
- Length of stay in the Emergency Departments(Participants will be followed for the duration of the hospital stay in the Emergency Department, an expected average of 17 hours)
- Length of stay in the Hospital(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Proportion of in-hospital death(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Proportion of in-hospital cardiac/respiratory arrest(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Safety awareness(up to 4 weeks (in baseline and in intervention))
- Proportion of participants with severe safety events(Participants will be followed for the duration of the hospital stay in the Emergency Department, an expected average of 17 hours)
- Proportion of participants admitted to the Intensive Care Units from the Emergency Departments(Participants will be followed for the duration of the hospital stay in the Emergency Department, an expected average of 17 hours)
- Proportion of participants admitted to the Intensive Care Units from the wards(Participants will be followed for the duration of hospital stay, an expected average of 1 week)