NCT02523456: EWS

Develop, Implement and Assess Effectiveness of Early Warning Score (EWS) for Moneragala District General Hospital

Completed NA Last updated 7 June 2017

What this trial tests

NA trial testing Training in Cardiac Arrest in 18,000 participants. Completed in 31 December 2016.

Timeline

1 May 2015

Primary endpoint
31 December 2016

31 December 2016

Quick facts

Lead sponsor	Ministry of Health, Sri Lanka
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	18,000
Start date	1 May 2015
Primary completion	31 December 2016
Estimated completion	31 December 2016
Sites	1 location across Sri Lanka

Drugs / interventions tested

• Training
• Introduce EWS

Conditions studied

• Cardiac Arrest — all drugs for Cardiac Arrest →

Sponsor

Ministry of Health, Sri Lanka

Who can join

18 and older, any sex, with Cardiac Arrest. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale: Early detection and timely interventions are important determinants of clinical outcome in people with acute illness. Adverse outcomes including unplanned transfer to intensive care (ICU), cardiac arrest and death are usually preceded by acute physiological changes manifesting as alterations in vital signs. Usage of early warning scores (EWS) based on bedside vital sign observations may help early detection, improve outcome of patients and reduce healthcare cost.

EWS which are effective in predicting deteriorating patients developed in high income countries have been shown to lose sensitivity and specificity when applied to a low income setting. It is imperative to explore the usefulness of EWSs in Sri Lanka. If the results are positive, widespread adaptation of these scores can significantly contribute to improved patient outcome, better utilization of ICU services and cost effective healthcare provision.

Objectives: To describe the demographic characteristics of cardiac arrest patients and the availability of physiological variables for calculation various EWSs in DGH, Moneragala To validate an early warning score suitable for patients at DGH, Moneragala To examine the effectiveness of the selected EWS at improving pre-defined patient outcomes

Proposed methodology:

Study I: All clinical variables and patient characteristics of past two years collected retrospectively from BHTs. Vital signs and laboratory measurements 24 and 48 hours before cardio respiratory emergency and at admission to hospital will be extracted. The availability of variables required for the calculation of various EWSs will be noted.

Study II: All consecutive inpatient admissions for three months to all units except intensive care unit at DGH, Moneragala will be included to the study, prospectively. Data will be collected from bed head tickets using pre-defined data sheets by nominated medical/ nursing officers daily. Demographic details and physiological data will be recorded on admission to ward. Physiological data for seven EWS will be collected twice daily by these medical/nursing officers.

Study III: Training will be given for the staff to identify patients getting worse using the newly validated EWS. The outcome of this will be measured with information obtained from Study II.

Ethical clearance obtained from the Ethics review Committee of the Faculty of Medicine, University of Colombo (EC-15-034).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluation of the feasibility and performance of early warning scores to identify patients at risk of adverse outcomes in a low-middle income country setting.
   Beane A, De Silva AP, De Silva N, Sujeewa JA, et al · · 2018 · cited 26× · PMID 29703852 · DOI 10.1136/bmjopen-2017-019387