Improving the Detection of Active Tuberculosis in Accident and Emergency Departments (ACE)

March 15, 2016 updated by: Jo Southern, Public Health England

Improving the Detection of Active Tuberculosis in Accident and Emergency (A&E) Departments

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.

Study Overview

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, Ha73qx
        • Barts NHS Trust
      • London, United Kingdom, NW95EQ
        • Ealing Hospital
      • London, United Kingdom
        • West Middlesex Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals at high risk of TB

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
xray diagnosis of active TB
Time Frame: 1 year
clinical signs and symptoms on xray
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnosis of latent TB
Time Frame: 1 year
positive blood test result by interferon gamma release assay (IGRA) in line with the manufacturer instructons for the test
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 27, 2015

First Submitted That Met QC Criteria

July 30, 2015

First Posted (Estimate)

July 31, 2015

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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