Individual Early Warning Score (I-EWS)

NCT03690128 | Completed

• 1 other identifier: 17017332
• Study Type: interventional
• Target: 150,000
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Early Warning Score; Risk Stratification

Keywords

Clinical deterioration; Risk stratification; Patient Safety; Early Warning Score; Monitoring; Clinical assessment

Outcome Measures

Primary Outcomes (2)

• 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

• The number of NEWS/I-EWS scores per patient per day

  Assessed after one year, after completion of the study

Secondary Outcomes (3)

• Length of hospital stay

  30 days

• All Cause mortality at 2 days

  2 days (48 hours) after index admission

• All Cause mortality at 7 days

  7 days (168 hours) after index admission

Other Outcomes (41)

• 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

• 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

• The number of Cardiac arrests* during hospital stay, reported in numbers (%)

  Assessed after one year, after completion of the study

Study Arms (2)

Control Arm - standard EWS procedure

ACTIVE COMPARATOR

Standard use of the current implement Early Warning System, based on the principles of the National Early Warning Score and with a standard escalation protocol.

Behavioral: Standard EWS - Control (Trigger Tool)

Intervention Arm - I-EWS

ACTIVE COMPARATOR

Implementation of Individual Early Warning Score (I-EWS) with a systematic clinical assessment with a standard escalation protocol as intervention 7 parameters (Respiration rate, pulse, saturation, systolic blood pressure, consciousness, temperature, Oxygen) are registered , an aggregated score is generated. In the electronic patient journal (Sundhedsplatformen), the nursing staff is asked to reevaluate the aggregated score based on their clinical assessment of the patient. The aggregated score can be upgraded with up to 6 points and downgraded with up to 4. This new I-EWS score interacts with the standard escalation protocol which defines the observation frequency and relevant clinical actions.

Behavioral: I-EWS with incorporated clinical assessment (Trigger Tool)

Interventions

I-EWS with incorporated clinical assessment (Trigger Tool) BEHAVIORAL

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.

Intervention Arm - I-EWS

Standard EWS - Control (Trigger Tool) BEHAVIORAL

Standard EWS - Based on principles of National Early Warning Score (NEWS)

Control Arm - standard EWS procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (8)

Bispebjerg Hospital

Copenhagen, Capital Region of Denmark, 2400, Denmark

Location

Amager & Hvidovre Hospital

Copenhagen, Capital Region of Denmark, 2650, Denmark

Location

Herlev & Gentofte Hospital

Copenhagen, Capital Region of Denmark, 2730, Denmark

Location

Rigshospital, Glostrup, Medical Ward

Glostrup Municipality, Capital Region of Denmark, 2600, Denmark

Location

Nordsjaellands Hospital

Hillerød, Capital Region of Denmark, 3400, Denmark

Location

Holbaek Hospital

Holbæk, Region of Zealand, 4300, Denmark

Location

Zealand University Hospital (Roskilde & Køge)

Roskilde, Region of Zealand, 4000, Denmark

Location

Slagelse Sygehus

Slagelse, Region of Zealand, 4200, Denmark

Location

Related Publications (2)

• Nielsen PB, Langkjaer CS, Schultz M, Kodal AM, Pedersen NE, Petersen JA, Lange T, Arvig MD, Meyhoff CS, Bestle MH, Holge-Hazelton B, Bunkenborg G, Lippert A, Andersen O, Rasmussen LS, Iversen KK. Clinical assessment as a part of an early warning score-a Danish cluster-randomised, multicentre study of an individual early warning score. Lancet Digit Health. 2022 Jul;4(7):e497-e506. doi: 10.1016/S2589-7500(22)00067-X. Epub 2022 May 19.

  PMID: 35599143 DERIVED

• Nielsen PB, Schultz M, Langkjaer CS, Kodal AM, Pedersen NE, Petersen JA, Lange T, Arvig MD, Meyhoff CS, Bestle M, Holge-Hazelton B, Bunkenborg G, Lippert A, Andersen O, Rasmussen LS, Iversen KK. Adjusting Early Warning Score by clinical assessment: a study protocol for a Danish cluster-randomised, multicentre study of an Individual Early Warning Score (I-EWS). BMJ Open. 2020 Jan 7;10(1):e033676. doi: 10.1136/bmjopen-2019-033676.

  PMID: 31915173 DERIVED

MeSH Terms

Conditions

Clinical Deterioration

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kasper Iversen, MD, DMSci

  Department of Cardiology, Herlev Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor, Consultant, DMSci

Model Details: A prospective, cluster randomized, cross-over, non-inferiority study

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 1, 2018
• Study Start: October 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: November 4, 2019

Record last verified: 2019-11

Locations

DK (8)