Risk Stratification Clinical Trial
Official title:
Individual Early Warning Score (I-EWS) - Does Clinical Assessment Improve Detection of Acute Deterioration in Hospitalized Patients - a Cluster-randomized Trial
Early Warning Score (EWS) is a clinical scoring system used in hospitals in Denmark and internationally to systematically observe admitted patients using a standardised response algorithm. Consisting of a score based on the patients' vital signs, it only leaves limited space for individual assessment. Patient safety but also resource utilisation is a key issue in health systems today. We have developed a new individual EWS system (I-EWS) that reintroduces the individual clinical assessment for a more personalised observation. Our hypothesis is that I-EWS will not increase the mortality among hospitalised patients compared to EWS but will improve workflow by reducing unnecessary observations and freeing staff resources, potentially leading to improved patient care. The impact of I-EWS on mortality, the occurrence of critical illness, and usage of staff resources will be evaluated in a prospective, cluster randomised, non-inferiority study conducted at eight hospitals in Denmark.
Every year more than 250,000 patients are admitted in the Capital Region of Denmark. During
admissions, the clinical track and trigger system "Early Warning Score" (EWS) is used to
systematically observe and detect acutely deteriorating patients. The system is designed to
prevent serious adverse events like unanticipated transfer to the intensive care unit,
cardiac arrest and unexpected death. EWS consists of standardized measurements of the
patient's vital signs and an escalation protocol that determines further actions based on the
aggregated EWS score. At admission, and as a minimum twice a day, nurses measure vital signs
on all hospitalized patients. Depending on the predetermined cut-off values (i.e. heart rate
above 150 bpm = 3 points) an aggregated score is calculated. Based on the total score, the
escalation protocol determines the time interval for the next measurement as well as a
clinical action (i.e. call for attending doctor). EWS is developed to detect and to treat
potentially deterioration of disease that might lead to critical illness and death. In its
current form, there is only limited room for individual clinical assessment.
A standardized track and trigger system like EWS does not differentiate between different
types of disease or the patient's individual physiological response. Therefore, there is a
potential risk that the system fails to detect a patient with an abnormal stress response.
Additionally; patients suffering from chronic illness might have different normal values than
healthy patients, leading to unnecessarily excess observation, measurement, and suboptimal
usage of limited staff resources.
Previous studies have shown that Early Warning System scores perform well for prediction of
cardiac arrest and death within 48 hours, although the impact on health outcomes and resource
utilization remains uncertain, often owing to methological limitations.
It is possible, but never studied before, whether the combination of vital signs with
individual clinical assessment is a better tool for identifying hospitalized high-risk
patients than the existing algorithms.
Further improvement and optimizing of the EWS is necessary, as there is potential to improve
patient care and use staff resources more appropriate.
The purpose of the study is to investigate the impact of the I-EWS that has a systematic
involvement of clinical assessment and the possibility to adjust the score, whilst keeping
the same escalation protocol. I-EWS will be compared to the existing EWS with a focus on
mortality, critical illness, and the use of staff resources.
Our hypothesis is that I-EWS, where clinical assessment is given a more prominent role will
not increase the mortality among hospitalized patients but can reallocate personnel
resources.
I-EWS is built in to electronic patient journal system "Sundhedsplatformen" it is only
available in Sundhedsplatformen (SP) at hospitals assigned to I-EWS. Four hospitals are
randomized to use I-EWS for 6,5 months, the remaining four hospitals are control hospitals
using the current EWS in this period.
After 6,5 months a single cross-over will be preformed, and the previous control hospitals
will use I-EWS over the next 6,5 months and the previous intervention hospitals, will go back
to the current EWS for this period.
EWS scores and subsequent actions are documented in real time in SP. The first two weeks and
final four weeks of each period will be excluded due to a implementation period. Data
regarding patients, interventions and serious adverse events during hospitalization (i.e.,
cardiac arrest, the request of MET or unexpected death) will be accessed through SP and the
Danish Central Registries (The Danish National Patient Registry, the Civil Registration
System, DanArrest). After extraction, all data will be depersonalization and stored at a
secured network in accordance with the current guidelines for data management in the Capital
Region of Denmark.
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