Tuberculosis Clinical Trial
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:
1. 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)
2. implement a screening programme comprising education, resources and clinical support
for intervention practices using proven behaviour change strategies
3. gather outcomes and costs
4. 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.
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
;
Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal
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