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

NCT02523456 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18000

Last updated 2017-06-07

No results posted yet for this study

Summary

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).

Conditions

  • Cardiac Arrest

Interventions

BEHAVIORAL

Training

The staff will be trained on early detection and management of clinically deteriorating patients based on the EWS selected.

BEHAVIORAL

Introduce EWS

An EWS that is appropriate for use in the study setting will be selected during the second components of the study. This EWS will then be adapted for this component.

Sponsors & Collaborators

  • National Intensive Care Surveillance

    collaborator OTHER
  • Ministry of Health, Sri Lanka

    lead OTHER_GOV

Principal Investigators

  • Rashan Haniffa, MBBS, FRCA · Mahidol Oxford Tropical Medicine Research Unit

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Sri Lanka

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02523456 on ClinicalTrials.gov