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Increasing use of smoking cessation services with risk information and taster sessions
ISRCTN ISRCTN76561916
DOI 10.1186/ISRCTN76561916
ClinicalTrials.gov identifier
EudraCT number
Public title Increasing use of smoking cessation services with risk information and taster sessions
Scientific title A randomised trial to increase the uptake of smoking cessation services using personal tailored risk information and taster sessions
Acronym Start2quit
Serial number at source HTA 08/58/02
Study hypothesis Smokers, identified from general practice records, sent brief personal tailored letters based on characteristics available in their primary care medical records and on a short screening questionnaire, and invited to a 'Come and Try it' taster session designed to inform them about the NHS services, are more likely to attend the services than those who receive a standard generic letter advertising the service.
Lay summary Not provided at time of registration
Ethics approval South London REC 4 on 21/04/2010 (REC ref: 10/H0806/20)
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Smoking cessation
Participants - inclusion criteria All current smokers:
1. Willing to participate and returning the signed consent form
2. Aged 16 years and over, either sex
3. Able to read English
4. Motivated to quit
5. Have not previously attended the NHS services
Participants - exclusion criteria Exclusion criteria are minimal because the aim is to recruit all smokers into the services. However, smokers younger than 16 will be excluded because of the need for parental consent to participate for this age group, and any patients identified who are considered by the GP to be unsuitable for the project, e.g. severely or terminally ill, will be excluded.
Anticipated start date 01/04/2010
Anticipated end date 31/03/2014
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 2520
Interventions Control group:
A standard generic letter sent from the surgery advertising the NHS stop smoking service and asking the smoker to contact the service to make an appointment to see an advisor.

Intervention group:
There are two components to the intervention:
1. A brief motivational letter sent from the GP that includes information specific to the patient. The letter will be personalised and tailored using known characteristics (i.e. age and gender), and information obtained from the screening questionnaire (i.e. dependence, previous quit attempts, motivation and confidence). Information from medical records about the patients general health status and about chronic conditions e.g. heart disease, diabetes, lung disease, will also be used to offer risk information and to offer help to improve their condition by quitting smoking. The letter will include an invitation and an appointment to attend a 'Come and Try it' taster session to find out more about the services.

We will maximise the amount of tailoring within the constraints of the short screening questionnaire and brief letter. The exact content of the letter will be developed in collaboration with GPs and primary care experts with greater knowledge of medical information available in records.

2. The 'Come and Try it' taster session, run by advisors from the local service. This session will include:
2.1. An explanation that the advice and help offered by the NHS service is based on evidence, with a higher likelihood of success
2.2. Information about the services offered, i.e. one-to-one or group sessions, the length of a session and the length of the course, nicotine replacement therapy (NRT) or other pharmacotherapy as well as behavioural support
2.3. Information about what to expect when they attend and the content of advice (e.g. help dealing with weight gain, the correct use of NRT, depression, expected outcomes)
2.4. A measurement of expired-air carbon monoxide (CO) with an interpretation
2.5. A 10 to 15 minute video showing group and one-to-one sessions in progress, and testimonials from previous successful attendees. This will be standardised on the understanding that, while services may differ in the way they are organised, the protocols for delivering advice are standardised.
2.6. The opportunity to ask questions about the service
2.7. The expectations of the service, i.e. willingness to set a quit date

Each PCT will run 6 taster sessions, and approximately 25 participants will be invited to each session which will last approximately 1.5 hours. Attendees will be encouraged to sign up to a group or one-to-one session at a time convenient to them, at the end of the taster session. Participants who fail to attend will receive a further invitation three months later to encourage attendance.
Primary outcome measure(s) The proportion of people entering the smoking cessation service (i.e. attending the first session of a 6-week course) over a period of 6 months from the receipt of the invitation letter. Self-reported attendance data will be validated by records of attendance at the NHS services.
Secondary outcome measure(s) 1. 7-day point prevalent abstinence at the 6-month follow-up, validated by salivary cotinine for all participants reporting abstinence in both the intervention and control groups
2. Prolonged periods of abstinence of 7 days to 24 weeks measured by self-report
3. Self-reported changes in daily cigarette consumption, quit attempts, and changes in motivation and intention to quit in continuing smokers
4. Use of NRT or Zyban or Champix and other smoking cessation aids
5. The number completing the 6-week NHS course
6. Process measures:
6.1. The number of smokers attending the taster session (intervention group only)
6.2. Perception of the personal invitation letters
6.3. Reasons for non-attendance at the taster session and barriers to attendance at the NHS services
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website http://www.ucl.ac.uk/start2quit/
Publications 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23078797
Contact name Dr  Hazel  Gilbert
  Address Research Department of Primary Care and Population Health
UCL Medical School
Royal Free Campus
Rowland Hill Street
  City/town London
  Zip/Postcode NW3 2PF
  Country United Kingdom
  Tel +44 (0)20 7317 7548
  Email hazel.gilbert@ucl.ac.uk
Sponsor University College London (UCL) (UK)
  Address 1st Floor, Maple House
149 Tottenham Court Road
  City/town London
  Zip/Postcode W1T 7NF
  Country United Kingdom
  Email david.wilson@ucl.ac.uk
  Sponsor website: http://www.ucl.ac.uk/joint-rd-unit/about-us
Date applied 08/12/2009
Last edited 26/07/2013
Date ISRCTN assigned 10/12/2009
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