Development, Implementation and Validation of an Early Warning System for Clinical Deterioration in Hospitalised Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Clinical deterioration
研究概览
简要总结
At present, there is no universal early warning system implemented in all Basque hospitals, but there are previous experiences, sometimes based on models generated in other health systems. In this project we intend to provide a robust model, based on the analysis of patient data from three Basque hospitals, i.e. generated in our population.
A three-phase study has been designed:
- st phase: Derivation of the predictive model by means of a reprospective cohort study in which patients hospitalised at the Galdakao-Usansolo Hospital, Donostia University Hospital and Araba University Hospital will be recruited.
- nd phase: Creation of an alarm system based on the probability of risk of clinical deterioration and implementation of the system in the electronic medical record (EHR) of the HGU, in the form of an "Action Guide".
- rd phase: The model will be validated by comparing the percentages of clinical deterioration by means of a quasi-experimental intervention study, comparing the results of the HGU hospital where the system will be implemented, before and after the intervention and, on the other hand, with those of Hospital Universitario Donostia (HUD) and Hospital Universitario de Araba (HUA), where normal clinical practice will be followed, with an early warning system based on vital signs in HUD and clinical criteria in HUA.
Sociodemographic and clinical variables will be collected (patient's condition on arrival on the ward, main diagnosis, comorbidities, prescribed treatments and procedures performed during hospitalisation and prior to the onset of deterioration) and laboratory parameters.
This information will be extracted from the osabide global data exploitation system, Oracle Business Intelligence, and the laboratory data will be extracted from the information systems of the clinical laboratories of the participating centres.
Logistic regression models will be created with the dependent variable being clinical deterioration (cardiorespiratory arrest, death, admission to intensive care units) on a database of 10000 hospitalised patients. For external validation, at least 8000 admissions will be prospectively evaluated and multilevel modelling will be performed to see the influence of centre membership on the outcome variable. Confounding will be controlled for using propensity-score techniques.
详细描述
Phase 1. Derivation of the predictive model Data from patients admitted to the participating centres during 2017 will be extracted from the OBI electronic medical record and the laboratory data management system. The data analyst contracted in this project, together with clinical collaborators, from the health management unit and the research unit, will be responsible for cleaning and cleaning the data and for the generation and internal validation of the predictive model.
Phase 2: Implementation in the electronic medical record: Once the model and the risk scale have been generated, it will be implemented as an alarm system in Osabide Global in the participating centres. To this end, an action guide will be created by the HGU's UGS, which, once validated, will then be exported to the other two centres. The system will operate on the basis of the RIC elements associated with vital signs, and will guide professionals through the process, so that the physician will be shown the analytical data that have been shown to be necessary to calculate the risk, or in the event that the patient has not been asked for that specific laboratory test, recommendations for extraction. Once the system has all the data, a warning will pop up on the screen with the results of the risk scale and the mild-moderate-severe risk category and a report with recommendations for action.Recommendations based on the ViEWS scale, from the physician informing the nurse in charge at the start of continuous monitoring and visit in less than 15 minutes by the responsible attending physician who will also inform the ICU physician to the transfer of the patient to a unit where he/she will be monitored and acted upon, are given in annex 1. The alarm system will be presented in the HGU by the clinical collaborators, GSU and data analyst. The data analyst will be, together with the co-researchers, the person in charge of generating the alarm system, of participating in the meetings in which it is presented in the centres and subsequently, will carry out a constant exploration of the use and adherence of the risk scale, will collect doubts and problems that may arise from the implementation of the system, and will also be responsible for the implementation of the risk scale.
Phase 3: External validation of the predictive model. Comparison of clinical outcomes: The predictive model will be validated once 100 events per centre have occurred (hopefully once about 8000 patients have been admitted). During this time, data will be collected during and after implementation in order to compare clinical deteriorations observed before and after implementation. The data analyst will be extracting the information, sorting and cleaning it in order to be able to carry out the corresponding statistical analyses later on.
STATISTICAL ANALSIS
The data processing procedure of the present project will be established following the following steps, divided into two sections:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •patients over 18 years of age hospitalised on conventional hospital wards, in medical and surgical departments or awaiting a bed during their stay in the emergency department.
排除标准
- •patients with a poor prognosis for life and a DNR order.
结局指标
主要结局
Clinical deterioration
时间窗: at least 24 hours after admission
death in admission or length of stay more than 12 hours in intensive or intermediary care unit (ICU).
次要结局
未报告次要终点
研究者
Susana García Gutiérrez
Researcher
Hospital Galdakao-Usansolo
