STOP trial
Research type
Research Study
Full title
A training and service intervention to Optimise Pharmacist-Based Treatment for Smoking Cessation: A cluster randomised controlled trial
IRAS ID
169967
Contact name
Robert Walton
Contact email
Sponsor organisation
Queen Mary University of London
Clinicaltrials.gov Identifier
17/LO/0098, REC Reference
Duration of Study in the UK
1 years, 9 months, 31 days
Research summary
Summary of Research - Community pharmacists or smoking cessation advisors are currently experiencing a rapid expansion of their role providing front line services for the NHS. This is a direct result of policy which identifies pharmacies as being an easily accessible and cost effective platform for delivering health care. Smoking cessation is one of the earlier tasks given to pharmacists/smoking cessation advisers. While a large number of people who smoke passing through the NHS Stop Smoking Programme (NHS SSP) quit, a significant number of people do not. To date there has been very little research to find out the best ways of helping people to Stop Smoking in community pharmacies.
This study (called the STOP study) will test whether a service improvement and training programme (called the STOP intervention) for pharmacy staff (pharmacists who are smoking cessation advisers and other pharmacy support staff e.g. counter assistants who might not be trained in smoking cessation) in community pharmacies will improve the uptake and reduce dropouts in the NHS Stop Smoking Programme and improve quit rates. The STOP intervention has been developed through a systematic review of community pharmacy based interventions, a detailed qualitative study (REC ref 13/SC/0189), and refined following a pilot study (REC ref 14/LO/2162).
We will now test the STOP intervention in 60 community pharmacies in North East London, South London (Southwark and Lambeth), Warwick and South East Wales to see whether the intervention is effective and cost-effective in improving the uptake and reducing dropout in the NHS SSP and thereby improving quit rates. The study will last 22 months.Summary of Results: Background Community pharmacies serve people with high levels of tobacco-related illness, but throughput in NHS Stop Smoking Services in pharmacies remains relatively low. We investigated the effectiveness of a complex intervention to increase service uptake and retention. Methods We randomised 60 pharmacies in England and Wales to the STOP intervention or usual practice in a pragmatic, parallel-group, controlled trial over 11 months. Smokers were blind to the allocation.
The intervention was theory-based consultation skills training for pharmacy staff with environmental prompts (badges, calendars and behavioural cues). The primary outcome was the number of smokers attending an initial consultation and setting a quit date. Results The intervention made no significant difference in setting a quit date, retention or quit rate. A total of 631 adult smokers (service users) enrolled and set a quit date in intervention pharmacies compared to 641 in usual practice pharmacies, a rate ratio of 0.75 (95% CI 0.46 to 1.23) adjusted for site and number of prescriptions. A total of 432 (68%) service users were retained at 4 weeks in intervention and 500 (78%) in usual practice pharmacies (odds ratio 0.80, 0.41 to 1.55). A total of 265 (42%) service users quit smoking at 4 weeks in intervention and
276 (43%) in usual practice pharmacies (0.96, 0.65 to 1.43). The pharmacy staff were positive about the intervention with 90% (56/62) stating that it had improved their skills. Sixty-eight per cent would strongly recommend the training to others although there was no difference in self-efficacy for service delivery between arms.
Seventy of 131 (53%) service users did not complete the 6-month follow-up assessment. However, 55/61 (90%) service users who completed follow-up were satisfied or very satisfied with the service. All usual practice arm service users (n = 33) and all but one in the intervention arm (n = 27) would recommend the service to smokers. Conclusions We found high levels of retention and acceptable quit rates in the NHS pharmacy stop smoking service. Despite pharmacy staff providing positive feedback on the STOP intervention, it made no difference to service throughput. Thus, other factors may currently limit service capacity to help smokers to quit.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
17/SC/0067
Date of REC Opinion
3 Apr 2017
REC opinion
Further Information Favourable Opinion