Improving the Detection of Active Tuberculosis in Accident and Emergency Departments

• Conditions: Latent Tuberculosis; Active Tuberculosis
• Interventions: Procedure: venepuncture, sputum collection, xray

• Registration Number: NCT02512484
• Lead Sponsor: Public Health England

Brief Summary

Tuberculosis (TB) control remains a public health challenge. Many people in the UK do not have a general practitioner (GP) registration and their only interaction with the NHS is via Accident and Emergency (A\&E) Departments of hospitals. This is often the case for those in hard to reach groups, who are also those often at highest risk of TB. This study seeks to assess whether A\&E Departments are effective sites for the identification and onward management of TB, both in its latent and active forms.

Detailed Description

This proposal is focused upon early diagnosis, referral and treatment of active tuberculosis, which has two key components: 1) ensuring optimal outcome for individuals; 2) contributing to disease control in public health terms by preventing further spread.

A\&E Departments are an important point of testing and referral for the client group that constitute those at greatest risk, as for many this will be their only interaction with the health service. Currently, A\&E Departments contribute about 20% of those diagnosed with TB. The majority of these individuals are most likely to have presented with symptoms indicative of disease, compared to those attending for other reasons who would have been unlikely to have been tested or referred.

This study will seek to evaluate specific measures currently being undertaken by Public Health England and the NHS to control TB as well as investigate whether case finding for active TB in A\&E departments would improve TB control. The economic impact of these interventions will be evaluated, providing a measure of its value for money.

Study Timeline

• Study First Submitted: 2015-07-27
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-07-31
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-16
• Study Start: 2016-05
• Primary Completion: 2017-05
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Individuals 16 years or older, who are new entrants from high incidence countries who have arrived in the UK within the past 2 years or those born in high incidence countries who entered the UK more than five years ago, but have spent more than one year (cumulative) in the past five years in a high incidence country.
2. Those with social risk factors who have signs and/or symptoms of TB.

Exclusion Criteria

1. Individuals who are under 16 years
2. Individuals who were born in the UK or a low incidence countries and do not have risk factors

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
high risk TB individuals attending A&E Departments	venepuncture, sputum collection, xray	Assessment against inclusion/exclusion criteria in terms of risk of TB. If eligible, assessment and testing as appropriate for active or latent TB

Primary Outcome Measures

Name	Time	Method
xray diagnosis of active TB	1 year	clinical signs and symptoms on xray

Secondary Outcome Measures

Name	Time	Method
diagnosis of latent TB	1 year	positive blood test result by interferon gamma release assay (IGRA) in line with the manufacturer instructons for the test

Trial Locations

Locations (3)

Barts NHS Trust; 🇬🇧 London, United Kingdom

Ealing Hospital; 🇬🇧 London, United Kingdom

West Middlesex Hospital NHS Trust; 🇬🇧 London, United Kingdom