The National Knowledge Service Tuberculosis Pilot Evaluation Study

ISRCTN	ISRCTN14195036
DOI	https://doi.org/10.1186/ISRCTN14195036
Secondary identifying numbers	N/A

Submission date: 18/01/2008
Registration date: 14/02/2008
Last edited: 16/02/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Ibrahim Abubakar
Scientific

Head TB Section
Health Protection Agency
Colindale
London
NW9 5EQ
United Kingdom

Email	Ibrahim.Abubakar@hpa.org.uk

Study information

Study design	Multi-centre randomised controlled trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Evaluation of information resources: a randomised control study and qualitative review
Study acronym	The NKS- TBP Evaluation Study
Study objectives	Tuberculosis is a serious, but treatable infectious disease. About 8,000 new cases of TB are currently reported each year in the United Kingdom (Annual Surveillance report 2006). In 2004 the national action plan "Stopping Tuberculosis in England" set out a strategy for the "reduction and ultimately elimination of TB in the UK". The immediate targets in the action plan are to: 1. Reduce risk of TB 2. Provide high quality treatment for all with TB and 3. Maintain low levels of drug resistance The first recommendation on how to accomplish these tasks is by "increasing awareness" among healthcare professionals, high risk groups and people who work with them and patients and member of the public. Educational interventions has clearly demonstrated to help General Practitioner's detect tuberculosis in primary care. The aim of this project is to mobilise current evidence-based guidance and expert opinion to create knowledge and inform decision-making by professionals, carers and the public with regards the recognition and management of tuberculosis (TB). The National Knowledge Service Tuberculosis Pilot (NKSTBP) was set up to provide information that would be directly relevant to people who need to be aware of, and take actions about, the treatment, prevention and management of TB. The target audience are patients, members of the public and healthcare professionals, others with a duty of care. Information resources have been/are being developed to raise awareness on TB among target groups as identified by members of the NKSTBP programme board. As the rate of tuberculosis is higher among certain vulnerable groups the NKSTBP considered that carers who are working closely with these groups should be made targeted in the effort to raise awareness and knowledge of TB in the first instance. This should provide key staff with some guidance on how they can help and support their clients. This study aims to evaluate a variety of information resources for specific target groups using a multi method approach. The evaluation will determine whether the information has contributed to an in increase in knowledge about TB. The methods to be used for the evaluation include: 1. A qualitative study to explore the opinion of targeted users regarding the benefits of and how best to present these leaflets 2. An observational study using a before and after approach to assess the gain in knowledge 3. A randomised controlled trial to determine whether the leaflets have contributed to a gain in short term knowledge of TB It is the randomised controlled trial that is the subject of this protocol.
Ethics approval(s)	A formal enquiry was sent to the Camden & Islington Community Local Research Ethics Committee based on the first batch of resources (Homeless sector) produced for this project, which we will be evaluating using the same study design. Application was submitted on the 11th of June 2007 and a reply was received on the 11th of July confirming that this study is an evaluation of a health service and therefore does not require full ethical review.
Health condition(s) or problem(s) studied	Tuberculosis (TB)
Intervention	To detect a 40% increase in knowledge between the two arms with 80% power 5% error, a sample size of 180 participants are required. Randomisation will be undertaken using random numbers generated on the Statistical software Stata by the study team at the Centre for Infections in Colindale. The allocation is then communicated to the head of the relevant organisation for each person to be sent either an intervention or control information resource. The group conducting the study will be blinded to the intervention received by each participant. The intervention being evaluated is an information leaflet about various aspects of tuberculosis. Resources provided have information on the following: 1. Recognizing the key symptoms, diagnosis and treatment available 2. Client advocacy 3. How to support treatment 4. Referral pathway 5. Risks and precautions for staff 6. Website addresses were further information can be obtained Participants allocated to the control group will receive a resource which is not on TB, e.g., "mental health and substance mis-use." The gain in knowledge among participants will be compared using "intention to treat analysis". The ratio of proportional gain in knowledge will be adjusted for previous knowledge and experience of tuberculosis. Knowledge gain will be assessed through before and after questionnaires. Total duration of intervention: 4 months (from 15th January 2008 to 15th May 2008)
Intervention type	Other
Primary outcome measure	Gain in knowledge as measured by the difference in score obtained after the intervention compared to the level before the intervention (questionnaires).
Secondary outcome measures	No secondary outcome measures
Overall study start date	15/01/2008
Completion date	15/05/2008

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	Both
Target number of participants	180
Key inclusion criteria	The main inclusion criterion for qualitative whole study is that individuals must fall within the targeted groups. These groups include: 1. Drug and alcohol mis-users and staff working with them 2. Patient information sheet (pregnancy leaflet) 3. Clinicians (managing pregnant women exposed to TB) 4. Homeless sector staff/managers (TB and homelessness) 5. Staff of the Asylum Seekers 6. Staff taking care of children with TB 7. Prison staff 8. Prisoners (cartoon leaflets on TB) For the randomised controlled trial component of the study, staff working with drug and alcohol mis-users and asylum seekers will be targeted. Individuals will be invited to participate through emails sent via their organisations mailing list. A sampling frame is available which consists of a list of all individuals employed by each organisation.
Key exclusion criteria	Individuals who either do not consent or those who are not in the relevant target group
Date of first enrolment	15/01/2008
Date of final enrolment	15/05/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Health Protection Agency

London
NW9 5EQ
United Kingdom

Sponsor information

Health Protection Agency (UK)
Government

61 Colindale Avenue
Colindale
London
NW9 5EQ
United Kingdom

Website	http://www.hpa.org.uk/
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

Department of Health - The Health Protection Agency (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2008		Yes	No