NCT04098705

Brief Summary

Triage is an important component of emergency care (EC). It aims to sort patients based on the urgency of their condition such that the highest acuity patients are prioritised for assessment and treatment. Grounded in the ethical principles of equity and justice, triage is necessary whenever there is a mismatch between demand for EC and the availability of resources. Globally, a large number of triage scales are in use. These differ in the data required to categorise patients as well as the number of tiers. Developed settings tend to utilise five-tier systems. Little is known about the prevalence of triage in low- and middle-income countries (LMICs), including in the Pacific region. There is also limited evidence about the utility, validity and reliability of triage scales in these contexts. While a landmark study in a paediatric Emergency Department (ED) in Malawi demonstrated that training staff in emergency skills, introducing triage and improving flow substantially reduced case fatality rates, the mortality reduction attributable to triage is unknown. A small number of triage scales have been developed for resource-limited (RL) environments. The most widely studied is the four-tier South African Triage Scale (SATS), which has demonstrated reasonable reliability and validity. In the Pacific region, SATS has provided a foundation for the three-tier Solomon Islands Triage Scale (SITS), which has recently been piloted in Honiara. The World Health Organization (WHO) has also recently released a three-tier triage scale. Neither of these instruments has been validated. Although the potential value of triage systems in resource-limited EDs is increasingly recognised, the current evidence base is limited. The impact on process indicators (eg, time to assessment) and clinical outcomes (eg, mortality) for time-critical conditions is largely unknown. This study aims to address this knowledge gap.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

September 9, 2019

Last Update Submit

December 2, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Time-to-assessment (TTA) by an ED clinician for ten time-critical conditions

    The primary outcome will be time-to-assessment (TTA) by an ED clinician for ten time-critical conditions: severe trauma, major burns, severe head injury, ruptured ectopic pregnancy, septic shock, myocardial infarction, severe asthma/COPD, severe pneumonia, meningitis and appendicitis.

    Time interval between the patient's arrival in ED and assessment by a treating clinician, assessed up to 24 hours following arrival

  • The proportion of patients selected clinical syndromes that are seen within a clinically appropriate timeframe

    The primary outcome will also be analysed by the proportion of patients with these clinical syndromes that are seen within a clinically appropriate timeframe (defined as 15 minutes)

    Within 15 minutes of arrival

Secondary Outcomes (3)

  • Length of hospital stay

    The duration of the hospital stay at the point of hospital discharge, assessed up to 1 month following admission

  • ED mortality

    Within the ED encounter, assessed up to approximately 7 days

  • Inpatient mortality

    Prior to discharge from the hospital, assessed up to 1 month post-admission

Other Outcomes (5)

  • Validity - predictive ability for disposition

    The patient's ED encounter, assessed up to approximately 7 days following arrival in the ED

  • Validity - predictive ability for death

    The patient's ED encounter, assessed up to approximately 7 days following arrival in the ED

  • Under- and over-triage rates

    The patient's ED encounter, assessed up to approximately 7 days following arrival in the ED

  • +2 more other outcomes

Study Arms (2)

Pre-intervention

NO INTERVENTION

Pre-intervention period

Post-intervention

EXPERIMENTAL

Post-intervention period

Other: Introduction of the World Health Organization Triage Scale

Interventions

The intervention will comprise implementation of a new triage and patient flow system facilitated through staff training and clinical redesign. The three-tier World Health Organization Triage Scale (WHOTS) will be used as the triage instrument. This tool, developed collaboratively by the WHO, International Committee of the Red Cross (ICRC) and Médecins Sans Frontières (MSF), incorporates features of the South African Triage Scale but has been modified for application in a wide variety of RL settings. WHOTS documents are provided in the research protocol.

Post-intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients presenting to Mount Hagen Provincial Hospital during the study period.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Hagen Provincial Hospital

Mount Hagen, Western Highlands Province, Papua New Guinea

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Cameron, FACEM

    Monash University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Pre-post intervention methodology will be used
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 23, 2019

Study Start

August 30, 2019

Primary Completion

December 30, 2019

Study Completion

February 29, 2020

Last Updated

December 4, 2024

Record last verified: 2024-11

Locations