Individual Early Warning Score (I-EWS)

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690128
• Other study ID #: 17017332
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: November 2019
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150000
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients =18 years of age admitted more than 24 hours to a ward at participating hospitals will be included.

Participating hospitals are

• Herlev & Gentofte Hospital

• Nordsjaellands Hospital

• Bispebjerg Hospital

• Rigshospitalet, Glostrup - Medical Ward

• Amager & Hvidovre Hospital

• Zealand University Hospital

• Slagelse Hospital

• Holbaek Hospital

Exclusion Criteria:

• Wards not using standard EWS, paediatric, obstetric and intensive, due to they use special variations (Pediatric early warning score, Obstetric Early warning Score or continous monitoring).

Related Conditions & MeSH terms

• Early Warning Score
• Risk Stratification

Intervention

Behavioral:
• I-EWS with incorporated clinical assessment (Trigger Tool)
In relation to systematic measurement of vital parameters the nursing staff will perform an individual clinical assessment of the patient and adjust the I-EWS score accordingly.
• Standard EWS - Control (Trigger Tool)
Standard EWS - Based on principles of National Early Warning Score (NEWS)

Locations

Country	Name	City	State
Denmark	Amager & Hvidovre Hospital	Copenhagen	Capital Region Of Denmark
Denmark	Bispebjerg Hospital	Copenhagen	Capital Region Of Denmark
Denmark	Herlev & Gentofte Hospital	Copenhagen	Capital Region Of Denmark
Denmark	Rigshospital, Glostrup, Medical Ward	Glostrup	Capital Region Of Denmark
Denmark	Nordsjaellands Hospital	Hillerød	Capital Region Of Denmark
Denmark	Holbaek Hospital	Holbæk	Region Of Zealand
Denmark	Zealand University Hospital (Roskilde & Køge)	Roskilde	Region Of Zealand
Denmark	Slagelse Sygehus	Slagelse	Region Of Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of changes in I-EWS scores that lead to an escalation or de-escalation in the escalation protocol		Assessed after one year, after completion of the study
Other	Comparison of changes in EWS score due to I-EWS modification (intervention group) and due to temporary or chronic acceptable values (control group)		Assessed after one year, after completion of the study
Other	The number of Cardiac arrests* during hospital stay, reported in numbers (%)	*Definition - Presence of a clinical cardiac arrest (as defined in the resuscitation guidelines) in patients without a DNAR (Do Not Attempt Resuscitation) order. Registered in DANARREST.	Assessed after one year, after completion of the study
Other	The number of Cardiac arrests* during hospital stay, reported in number per 10,000 ward days	*Definition - Presence of a clinical cardiac arrest (as defined in the resuscitation guidelines) in patients without a DNAR (Do Not Attempt Resuscitation) order. Registered in DANARREST.	Assessed after one year, after completion of the study
Other	Scores generating a call for Mobile Emergency team (MET) reported in absolute number (%)		Assessed after one year, after completion of the study
Other	Scores generating a call for Mobile Emergency team (MET) reported in absolute per 10,000 ward days		Assessed after one year, after completion of the study
Other	Scores generating a call for the attending doctor, reported in absolute number (%)		Assessed after one year, after completion of the study
Other	Scores generating a call for the attending doctor, reported per 10,000 ward days		Assessed after one year, after completion of the study
Other	All cause mortality - Subgroup analysis of patients admitted to Herlev-Gentofte Hospital	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	All cause mortality - Subgroup analysis of patients admitted to Nordsjaellands Hospital	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	All cause mortality - Subgroup analysis of patients admitted to Bispebjerg Hospital	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	All cause mortality - Subgroup analysis of patients admitted to Glostrup Hospital (Medical Ward)	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	All cause mortality - Subgroup analysis of patients admitted to Amager-Hvidovre Hospital	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	All cause mortality - Subgroup analysis of patients admitted to Zealand University Hospital	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	All cause mortality - Subgroup analysis of patients admitted to Slagelse Hospital	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	All cause mortality - Subgroup analysis of patients admitted to Holbaek Hospital	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	All cause mortality - Subgroup analysis of patients Age = 39 years	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	All cause mortality - Subgroup analysis of patients Age 40 to 69 years	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	All cause mortality - Subgroup analysis of patients Age = 70 years	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	All cause mortality - Subgroup analysis of patients diagnosed with cardiovascular disease	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	All cause mortality - Subgroup analysis of patients diagnosed with cancer disease	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	All cause mortality - Subgroup analysis of patients diagnosed with pulmonary disease	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	All cause mortality - Subgroup analysis of patients diagnosed with infectious disease	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	All cause mortality - Subgroup analysis of patients diagnosed with neurological disease	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	All cause mortality - Subgroup analysis of patients diagnosed with surgical condition	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	The number of NEWS/I-EWS scores per patient per day - Subgroup analysis of patients admitted to Herlev-Gentofte Hospital	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	The number of NEWS/I-EWS scores per patient per day - Subgroup analysis of patients admitted to Nordsjaellands Hospital	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	The number of NEWS/I-EWS scores per patient per day - Subgroup analysis of patients admitted to Bispebjerg Hospital	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	The number of NEWS/I-EWS scores per patient per day - Subgroup analysis of patients admitted to Amager-Hvidovre Hospital	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	The number of NEWS/I-EWS scores per patient per day - Subgroup analysis of patients admitted to Zealand University Hospital	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	The number of NEWS/I-EWS scores per patient per day - Subgroup analysis of patients admitted to Slagelse Hospital	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	The number of NEWS/I-EWS scores per patient per day - Subgroup analysis of patients admitted to Holbaek Hospital	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	The number of NEWS/I-EWS scores per patient per day - Subgroup analysis of patients Age = 39 years	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	The number of NEWS/I-EWS scores per patient per day - Subgroup analysis of patients Age 40 to 69 years	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	The number of NEWS/I-EWS scores per patient per day - Subgroup analysis of patients Age = 70 years	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	The number of NEWS/I-EWS scores per patient per day - Subgroup analysis of patients diagnosed with cancer	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	The number of NEWS/I-EWS scores per patient per day - Subgroup analysis of patients diagnosed with cardiovascular disease	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	The number of NEWS/I-EWS scores per patient per day - Subgroup analysis of patients diagnosed with pulmonary disease	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	The number of NEWS/I-EWS scores per patient per day - Subgroup analysis of patients diagnosed with infectious disease	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	The number of NEWS/I-EWS scores per patient per day - Subgroup analysis of patients diagnosed with neurological disease	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Other	The number of NEWS/I-EWS scores per patient per day - Subgroup analysis of patients diagnosed with surgical condition	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Primary	All Cause mortality at 30 days	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	30 days after index admission
Primary	The number of NEWS/I-EWS scores per patient per day		Assessed after one year, after completion of the study
Secondary	Length of hospital stay	Calculated as days from date of index admission to date of discharge	30 days
Secondary	All Cause mortality at 2 days	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	2 days (48 hours) after index admission
Secondary	All Cause mortality at 7 days	Time frame starts at the beginning of the index admission, defined as first admission in the study period.	7 days (168 hours) after index admission