1. Telephone Support to Stop Smoking: RCT investigating support of differing intensities & the option of no cost nicotine replacement therapy Linda Bauld University of Stirling Tim Coleman University of Nottingham, UK Graeme Docherty University of Nottingham, UK and colleagues

2. Background Smoking remains a public health problem but cessation interventions are effective. Many countries operate telephone quit lines as a source of support for smokers who want to quit They are a cost-effective approach to smoking cessation with the potential to reach significant numbers of smokers. Finding optimal methods of providing effective cessation interventions via quitlines will increase their effectiveness.

3. Background In mainly US studies, proactive (repeated calls from cessation advisor to client) appears more effective than reactive counselling (i.e. responding only to smokers calls). RCT offering NRT (USA) Hollis 2007 – free NRT offer increased quit rates by around 30% PORTSSS trial rationale: find optimal methods to improve quit rates NRT or no NRT ? Standard or more intensive telephone support?

4. Efficacy of Telephone Support In 2006 a Cochrane Review examined the efficacy of telephone counselling for smoking cessation by examining the findings of 48 trials. Proactive support increased the odds of long term cessation (OR = 1.41, 95%CI 1.27- 1.57).

5. Efficacy of Telephone Support The review concluded (Stead, Perera and Lancaster, 2006): Proactive telephone counselling helps smokers interested in quitting. There is evidence of a dose response; one or two brief calls are less likely to provide a measurable benefit. Three or more calls increases the odds of quitting compared to a minimal intervention such as providing standard self-help materials, brief advice, or compared to pharmacotherapy alone. Telephone quitlines provide an important route of access to support for smokers, and call-back counselling enhances their usefulness.

6. Reactive or Proactive Telephone Support Most of the trials in the Cochrane review were of PROACTIVE telephone support. Reactive: Provision of information to support quit with brief counselling, usually call initiated by smoker Proactive Repeated, sequenced calls made by counsellors to smokers. Proactive telephone support achieves approx. 1.4 times higher quit rates.

7. Telephone Support Compared: 4 week estimates Source: estimates provided by Paul Aveyard for NHS stop smoking service and monitoring guidance

8. Telephone Support in the UK In the UK, the management and delivery of quitlines varies between the four home countries There are two main forms of telephone support available for smokers who want to quit in England The NHS Smoking Helpline (delivered by The Listening Company who also deliver Smokeline in Scotland) Quit (who provide a range of services)

9. Telephone Support in England The NHS Smoking Helpline delivers a number of different types of support to smokers One of these is the Together Programme, which is a largely reactive form of telephone support consisting of a relatively large number of calls supported by written material, emails and texts. Together was the focus of this study.

10. Together Programme Developed in 2003, based on Prochaska Behavioural Change Model Timing/frequency of interventions was as follows: Communication ReceivedDescriptionMailEmailSMSCallback 1 - 6 weeks beforePreparationX 1 week beforeCountdown X 3 days beforeCountdown XX 2 days beforeSurvivalX Stop DateGood luck XXX 2 days afterMotivational X 1 week afterMotivational XX 3 weeks afterMotivational XXX 1 month afterHows it going?XXX 3 months afterMaintenanceXXX 12 months afterAnniversary XX Ad hocRelapseX

11. Methods Two by two parallel group RCT Two by two parallel group RCT Sample: callers of the English national quitline seeking help to stop Sample: callers of the English national quitline seeking help to stop February 2009 – January 2010. 16 years or over; Not pregnant; Need to agree to quit date February 2009 – January 2010. 16 years or over; Not pregnant; Need to agree to quit date Four treatment groups: Standard; Standard + NRT offer Standard; Standard + NRT offer More intensive; More intensive + NRT offer More intensive; More intensive + NRT offer

12. Recruitment and randomisation Standard N = 648 More Intensive n = 648 Standard + NRT N = 647 More Intensive +NRT n = 648 N = 5355 offered enrolment n = 2728 refused N = 2627 agreed N = 56 withdrew after randomisation ITT analysis n = 2591 Technical difficulties – not randomised n = 36

13. Results – type of support Comparison of proactive and usual care groups Proactive groups (n=1295) Usual care groups (n=1296) Unadjusted OR* (95% CI) 6 month quit rate (self report) 6 month quit rate (CO validated) 18.2% 7.7% 19.6% 8.3%.91 (0.75, 1.11).93 (0.70, 1.23) * Similar figures obtained when adjusted for age, sex, SES and HSI There was no interaction between interventions

14. Results – NRT Comparison of NRT and no NRT groups No NRT groups (n=1296) NRT groups (n=1295) Unadjusted OR* (95% CI) 6 month quit rate (self report) 6 month quit rate (CO validated) 20.1% 9.4% 17.7% 6.5%.85 (0.70, 1.04).67 (0.50, 0.90) * Similar figures obtained when adjusted for age, sex, SES and HSI There was no interaction between interventions

15. No NRT groups more likely to use non- trial cessation support? TherapyNo NRT groups n = 1296 NRT groups N = 1295 NRT without prescription 222 (17.1)276 (21.3) NRT from health professional 254 (19.6)225 (17.4) Zyban17 (1.3)20 (1.5) Champix101 (7.8)64 (4.9) NHS SSS group72 (5.6)53 (4.1) NHS 1:1118 (9.1)103 (8.0) Other quitline20 (1.5)

16. Conclusions 1. 1. Offering proactive telephone support via the NHS smoking helpline is no more effective than offering more reactive support (usual care) 2. Unless study specific reasons exist, more intensive behavioural support via a quitline not good use of resources in countries where cessation interventions are freely available

17. Conclusions 1. Offering free NRT no more effective than not offering NRT 2. Was this because those not given NRT vouchers made more use of NHS interventions? 3. Unless study specific reasons exist, offering NRT via a quitline not good use of resources in countries where cessation interventions freely available

18. Acknowledgements Funder: Department of Health (England) Essentia Ltd (now the Listening Group) – counsellors Credit care systems - databases University of Nottingham Clinical Trials Unit (data file preparation)

19. Thank You Linda.bauld@stir.ac.uk