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

NCT02523456 | Completed DMC

• 1 other identifier: EWS
• Study Type: interventional
• Target: 18,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Early warning score; Cardiac arrest

Outcome Measures

Primary Outcomes (1)

• Proportion of in-hospital cardiac arrests

  Reduction of proportion of in-hospital cardiac arrests among admitted patients

  Twelve months

Secondary Outcomes (2)

• Proportion of in-hospital deaths following cardiac arrests

  Twelve months

• Proportion of ICU admissions following cardiac arrests

  Twelve months

Study Arms (2)

Introduce EWS and Training on EWS

EXPERIMENTAL

The group of patients who admitted to a ward where the staff has trained on EWS and EWS has been introduced.

Behavioral: Training; Behavioral: Introduce EWS

EWS not introduced

NO INTERVENTION

The group of patients who admitted to a ward where the staff has no special training on EWS and EWS has not been introduced.

Interventions

Training BEHAVIORAL

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

Introduce EWS and Training on EWS

Introduce EWS BEHAVIORAL

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.

Introduce EWS and Training on EWS

Eligibility Criteria

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

You may qualify if:

• Patients who underwent CPR.
• Attendance of cardiac arrest team at this emergency. (When a cardiac arrest occurs in this hospital a cardiac arrest team attends)
• Age more than 18 years.

You may not qualify if:

• Patients who were under Do Not Resuscitate (DNR) instructions.
• Patients admitted to ICU.

Sponsors & Collaborators

• Ministry of Health, Sri Lanka: lead
• National Intensive Care Surveillance: collaborator

Study Sites (1)

DGH, Moneragala

Monaragala, Uva Province, Sri Lanka

Location

Related Publications (30)

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  PMID: 29703852 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rashan Haniffa, MBBS, FRCA

  Mahidol Oxford Tropical Medicine Research Unit

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project coordinator

Study Record Dates

• First Submitted: August 9, 2015
• First Posted: August 14, 2015
• Study Start: May 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: June 7, 2017

Record last verified: 2017-06

Locations

SR (1)