Start2quit: a randomised clinical controlled trial to evaluate the effectiveness and cost-effectiveness of using personal tailored risk information and taster sessions to increase the uptake of the NHS Stop Smoking Services.

Background: The NHS Stop Smoking Services (SSSs) offer help to smokers who want to quit. However, the proportion of smokers attending the SSSs is low and current figures show a continuing downward trend. This research addressed the problem of how to motivate more smokers to accept help to quit.

Objectives: To assess the relative effectiveness, and cost-effectiveness, of an intervention consisting of proactive recruitment by a brief computer-tailored personal risk letter and an invitation to a 'Come and Try it' taster session to provide information about the SSSs, compared with a standard generic letter advertising the service, in terms of attendance at the SSSs of at least one session and validated 7-day point prevalent abstinence at the 6-month follow-up.

Design: Randomised controlled trial of a complex intervention with follow-up 6 months after the date of randomisation.

Setting: SSSs and general practices in England.

Participants: All smokers aged ≥ 16 years identified from medical records in participating practices who were motivated to quit and who had not attended the SSS in the previous 12 months. Participants were randomised in the ratio 3 : 2 (intervention to control) by a computer program.

Interventions: Intervention - brief personalised and tailored letter sent from the general practitioner using information obtained from the screening questionnaire and from medical records, and an invitation to attend a taster session, run by the local SSS. Control - standard generic letter from the general practice advertising the local SSS and the therapies available, and asking the smoker to contact the service to make an appointment.

Main Outcome Measures: (1) Proportion of people attending the first session of a 6-week course over a period of 6 months from the receipt of the invitation letter, measured by records of attendance at the SSSs; (2) 7-day point prevalent abstinence at the 6-month follow-up, validated by salivary cotinine analysis; and (3) cost-effectiveness of the intervention.

Results: Eighteen SSSs and 99 practices within the SSS areas participated; 4384 participants were randomised to the intervention ( = 2636) or control ( = 1748). One participant withdrew and 4383 were analysed. The proportion of people attending the first session of a SSS course was significantly higher in the intervention group than in the control group [17.4% vs. 9.0%; unadjusted odds ratio (OR) 2.12, 95% confidence interval (CI) 1.75 to 2.57;  < 0.001]. The validated 7-day point prevalent abstinence at the 6-month follow-up was significantly higher in the intervention group than in the control group (9.0% vs. 5.6%; unadjusted OR 1.68, 95% CI 1.32 to 2.15;  < 0.001), as was the validated 3-month prolonged abstinence and all other periods of abstinence measured by self-report. Using the National Institute for Health and Care Excellence decision-making threshold range of £20,000-30,000 per quality-adjusted life-year gained, the probability that the intervention was more cost-effective than the control was up to 27% at 6 months and > 86% over a lifetime horizon.

Limitations: Participating SSSs may not be representative of all SSSs in England. Recruitment was low, at 4%.

Conclusions: The Start2quit trial added to evidence that a proactive approach with an intensive intervention to deliver personalised risk information and offer a no-commitment introductory session can be successful in reaching more smokers and increasing the uptake of the SSS and quit rates. The intervention appears less likely to be cost-effective in the short term, but is highly likely to be cost-effective over a lifetime horizon.

Future Work: Further research could assess the separate effects of these components.

Trial Registration: Current Controlled Trials ISRCTN76561916.

Funding Details: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 21, No. 3. See the NIHR Journals Library website for further project information.