TuberculosisNCT00214708
Can Screening People Registering With Primary Care Improve the Detection of Tuberculosis?
An observational study of Tuberculosis, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
This randomised controlled trial tests whether screening people registering with general practices cost-effectively increases the detection of tuberculosis. The study objectives are to: 1. Read more about this study
- Who is it for?
- Ages Up to 105 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Screening for Tuberculosis
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2002to Sep 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 105 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The intervention is screening for TB in general practices which were randomised to control or intervention
Who cannot join
- Practices that refused to participate could not be included. We excluded the general practice where the pilot study was undertaken
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Screening People Registering With Primary Care Improve the Detection of Tuberculosis? A Cluster Randomised Controlled Trial in an East London Primary Care Trust
This randomised controlled trial tests whether screening people registering with general practices cost-effectively increases the detection of tuberculosis. The study objectives are to:
- recruit, and randomise with stratification, forty Hackney general practices to usual activity or screening for TB primarily during registration health checks (by practice nurses and GPs) and transfer-in visits for children (by health visitors)
- implement a screening programme comprising education, resources and clinical support for intervention practices using proven behaviour change strategies
- gather outcomes and costs
- build research capacity within an ELENoR Primary Care Research Team and across a Primary Care Trust.
The primary outcome is the proportion of TB cases identified in primary care. The study is powered to detect a 20% increase (from 55% to 75%) in the detection of new cases of TB in primary care with 80% power at the 5% significance level. Secondary outcomes are rates of prophylaxis for latent TB infection (LTBI), BCG immunisation, smear negative (early) TB and costs. Analyses will be by intention to treat.
Read the detailed description
To date, studies of screening for tuberculosis have used relatively weak designs. A randomised trial would give stronger evidence as to whether screening is worthwhile and therefore would be welcome. We have tested the feasibility of screening in two general practices in Hackney; our results suggest that it is simple and straightforward, that the people screened were comfortable taking part, and that screening does indeed identify people with tuberculosis.
How (or indeed whether) to screen for tuberculosis constitutes a major policy issue for inner city public health care. Our work will go some way toward answering this important question and will have local, national and international relevance. There are important benefits for those taking part. First, the project is part of a local health development scheme which encourages GPs to register refugees and asylum seekers. This means that a group of people who find it difficult to get health care will be more likely to be able to find a GP. Second, people registering with general practices who are screening will all have a brief discussion about tuberculosis when they attend a health check at the surgery. This will make people more informed about tuberculosis and help to remove the stigma that attends tuberculosis. Third, screening is likely to identify people with tuberculosis, or who need BCG vaccination to prevent tuberculosis. These people will benefit from early treatment or immunisation.
We will invite all general practices in Hackney to take part. Practices that agree will then be randomly allocated (by a computer programme) into two groups: practices who will screen and those who will carry on as usual without screening. The project researcher responsible for data collection will not know to which group the practices have been assigned. Practices allocated to the screening group will be offered a programme designed to encourage screening as part of the new patient registration checks (by practice nurses and GPs) and during children's transfer-in visits (by health visitors). The programme is founded on proven ways of helping people change how they work and includes the following: an education programme run by the primary care research team, with a local chest consultant as opinion leader; Heaf guns, Heaf heads, and tuberculin (to test for presence of TB); TB screening guidelines; regular support and advice from the local TB specialist nurse; incorporation of a TB screening template into the practice computer consulting system; and an incentive fee paid to the practices for carrying out the Heaf tests. TB identication rates for both groups will be ascertained after 25 months of screening. The cost of implementing the screening process will also be measured.
Patients / public involvment (subjects and partners):
People attending for new registration checks and children seen at transfer-in visits are the study participants. They will be informed about the study (using information sheets in various languages); they can decline to take part if they like. Public involvement in the design and execution of the study comes in three forms. First, the East London Refuge and Asylum seeker worker has contributed to the study design and will be involved throught the study. Second, the work is part of an East London Health Improvement Plan, which itself has public support. Third, the study has approval from the East London and Esssex Network of Researchers' Research Advisory Committee, which has two consumer representatives
- Conditions
- Tuberculosis
- Being tested
- Screening for Tuberculosis
- Keywords
- Tuberculosis, Screening, Heaf, BCG
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for TuberculosisProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the proportion of TB cases identified in primary care. The study is powered to detect a 20% increase (from 55% to 75%) in the detection of new cases of TB in primary care with 80% power at the 5% significance level.
Secondary outcomes (1)
Secondary outcomes are rates of prophylaxis for latent TB infection (LTBI), BCG immunisation, smear negative (early) TB and costs. Analyses will be by intention to treat.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2002 (estimated)
- Primary completionSep 2002 (estimated)
- Study completionSep 2002 (estimated)
Why it stopped: Study withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Research and Development
- Investigators
- Chris J Griffiths, DPhil, MB BS, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214708
- Sponsor's protocol ID
- TB-02-04-CG
- Status last verified
- Feb 2025
- First submitted
- 16 Sep 2005
- Last updated
- 6 Feb 2025
- Results posted
- No
Publications
Griffiths C, Sturdy P, Brewin P, Bothamley G, Eldridge S, Martineau A, MacDonald M, Ramsay J, Tibrewal S, Levi S, Zumla A, Feder G. Educational outreach to promote screening for tuberculosis in primary care: a cluster randomised controlled trial. Lancet. 2007 May 5;369(9572):1528-1534. doi: 10.1016/S0140-6736(07)60707-7.
PubMed 17482983
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Screening People Registering With Primary Care Improve the Detection of Tuberculosis? A Cluster Randomised Controlled Trial in an East London Primary Care Trust
- ClinicalTrials.gov ID
- NCT00214708
- Acronym / sponsor ID
- TB-02-04-CG
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Screening, Heaf, BCG
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- NHS Research and Development
- Study start
- Jan 2002 (estimated)
- Primary completion
- Sep 2002 (estimated)
- Study completion
- Sep 2002 (estimated)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomised controlled trial tests whether screening people registering with general practices cost-effectively increases the detection of tuberculosis. The study objectives are to:
- recruit, and randomise with stratification, forty Hackney general practices to usual activity or screening for TB primarily during registration health checks (by practice nurses and GPs) and transfer-in visits for children (by health visitors)
- implement a screening programme comprising education, resources and clinical support for intervention practices using proven behaviour change strategies
- gather outcomes and costs
- build research capacity within an ELENoR Primary Care Research Team and across a Primary Care Trust.
The primary outcome is the proportion of TB cases identified in primary care. The study is powered to detect a 20% increase (from 55% to 75%) in the detection of new cases of TB in primary care with 80% power at the 5% significance level. Secondary outcomes are rates of prophylaxis for latent TB infection (LTBI), BCG immunisation, smear negative (early) TB and costs. Analyses will be by intention to treat.
Detailed description
To date, studies of screening for tuberculosis have used relatively weak designs. A randomised trial would give stronger evidence as to whether screening is worthwhile and therefore would be welcome. We have tested the feasibility of screening in two general practices in Hackney; our results suggest that it is simple and straightforward, that the people screened were comfortable taking part, and that screening does indeed identify people with tuberculosis.
How (or indeed whether) to screen for tuberculosis constitutes a major policy issue for inner city public health care. Our work will go some way toward answering this important question and will have local, national and international relevance. There are important benefits for those taking part. First, the project is part of a local health development scheme which encourages GPs to register refugees and asylum seekers. This means that a group of people who find it difficult to get health care will be more likely to be able to find a GP. Second, people registering with general practices who are screening will all have a brief discussion about tuberculosis when they attend a health check at the surgery. This will make people more informed about tuberculosis and help to remove the stigma that attends tuberculosis. Third, screening is likely to identify people with tuberculosis, or who need BCG vaccination to prevent tuberculosis. These people will benefit from early treatment or immunisation.
We will invite all general practices in Hackney to take part. Practices that agree will then be randomly allocated (by a computer programme) into two groups: practices who will screen and those who will carry on as usual without screening. The project researcher responsible for data collection will not know to which group the practices have been assigned. Practices allocated to the screening group will be offered a programme designed to encourage screening as part of the new patient registration checks (by practice nurses and GPs) and during children's transfer-in visits (by health visitors). The programme is founded on proven ways of helping people change how they work and includes the following: an education programme run by the primary care research team, with a local chest consultant as opinion leader; Heaf guns, Heaf heads, and tuberculin (to test for presence of TB); TB screening guidelines; regular support and advice from the local TB specialist nurse; incorporation of a TB screening template into the practice computer consulting system; and an incentive fee paid to the practices for carrying out the Heaf tests. TB identication rates for both groups will be ascertained after 25 months of screening. The cost of implementing the screening process will also be measured.
Patients / public involvment (subjects and partners):
People attending for new registration checks and children seen at transfer-in visits are the study participants. They will be informed about the study (using information sheets in various languages); they can decline to take part if they like. Public involvement in the design and execution of the study comes in three forms. First, the East London Refuge and Asylum seeker worker has contributed to the study design and will be involved throught the study. Second, the work is part of an East London Health Improvement Plan, which itself has public support. Third, the study has approval from the East London and Esssex Network of Researchers' Research Advisory Committee, which has two consumer representatives
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The intervention is screening for TB in general practices which were randomised to control or intervention
Key exclusion criteria (1 listed)
- Practices that refused to participate could not be included. We excluded the general practice where the pilot study was undertaken
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening for Tuberculosis | Procedure or surgery | – |
Primary outcome
The primary outcome is the proportion of TB cases identified in primary care. The study is powered to detect a 20% increase (from 55% to 75%) in the detection of new cases of TB in primary care with 80% power at the 5% significance level.
1 secondary outcome
Secondary outcomes are rates of prophylaxis for latent TB infection (LTBI), BCG immunisation, smear negative (early) TB and costs. Analyses will be by intention to treat.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Derived from this study: PubMed 17482983Griffiths C, Sturdy P, Brewin P, Bothamley G, Eldridge S, Martineau A, MacDonald M, Ramsay J, Tibrewal S, Levi S, Zumla A, Feder G. Educational outreach to promote screening for tuberculosis in primary care: a cluster randomised controlled trial. Lancet. 2007 May 5;369(9572):1528-1534. doi: 10.1016/S0140-6736(07)60707-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris J Griffiths, DPhil, MB BS principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the proportion of TB cases identified in primary care. The study is powered to detect a 20% increase (from 55% to 75%) in the detection of new cases of TB in primary care with 80% power at the 5% significance level.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00214708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.