Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214708
Status:
UNKNOWN
Last Update Posted:
2005-09-22
First Post:
2005-09-16
Brief Title:
Can Screening People Registering With Primary Care Improve the Detection of Tuberculosis
Sponsor:
Barts The London NHS Trust
Organization:
Barts The London NHS Trust
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
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 childrens 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
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 childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None