Specialty: Primary care, Primary sub-specialty: Public Health
Conditions
Interventions
The STOP trial is a pragmatic, cluster randomised controlled trial to assess the effect of the intervention on smoker recruitment into the NHS stop smoking programme and quit rates at four weeks and c
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: NHS SSP eligibility criteria: 1. Current smokers aged 18 and above 2. All types of smoking (cigarettes, cigar, pipe)
Exclusion criteria
Exclusion criteria: Exclusion criteria for community pharmacies and pharmacy staff: 1. Sites that lack the facilities for secure storage and transfer of the study data 2. Advisors who refuse GCP training Exclusion criteria for service users who will be part of the study exploring individual participant level outcomes: 1. Non-smokers 2. Unable to understand the STOP study service user information sheet and consent form 3. Unable/unwilling to give written informed consent for STOP study additional data collection procedures for detailed analysis Note: The risks and benefits of nicotine replacement need to be explained to pregnant or breastfeeding women and to people who have unstable cardiovascular disorders according to usual practice in the NHS Stop Smoking Service. Neither varenicline nor bupropion should be offered to pregnant or breastfeeding women. Varenicline or bupropion may be offered to people with unstable cardiovascular disorders, subject to clinical judgement https://www.nice.org.uk/guidance/PH10/chapter/1-Key-priorities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Throughput, defined as number of smokers who join the NHS SSP, attend a treatment session and set a firm quit date i.e. a ‘treated smoker’ (TS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: 1. 4 week retention rate, defined as proportion of treated smokers retained at 4 weeks i.e. a treated smoker is counted as ‘lost to follow up at 4-weeks’ (LFU4W) if, on attempting to determine the 4-week quitter status s/he cannot be contacted 2. 4 week quit rate, defined as proportion of smokers who quit smoking at 4 weeks from set quit date i.e. a ‘CO-verified 4-week quitter’ 3. Continuous abstinence rate, defined as proportion of smokers who quit at 4 weeks (CO-verified) and remained so at 6 months 4. Effect of the training intervention on additional (routine) data provided by the consented service users Process outcomes: 5. Satisfaction about the NHS SSP via questionnaire 6. Self-efficacy in smoking cessation delivery via questionnaire 7. Study recruitment and retention rates of pharmacies and pharmacy staff, reasons for non-participation and dropout, service user consent/recruitment rates for additional data collection and retention rates 8. Intervention training attendance and completion rates, reasons for non-attendance and dropout 9. Acceptability of intervention training and delivery in practice via questionnaire 10. Delivery of skills in practice at the pharmacy counter around engagement of service users into the NHS SSP via simulated client using checklist 11. Skills around retention of service users in pharmacy consultation room via audio-recording of consultations 12. Views and experiences about the STOP training and its delivery in practice 13. Views and experiences about the NHS SSP with a focus on engagement and retention, reasons for completion and non-completion of the NHS SSP Health economic outcomes: 1. Cost data from advisers: time spent (in minutes) by advisers on smoker service user delivering the NHS SSP and taking individual consent for STOP study additional data collection procedures and carrying out the data collection e.g. saliva samples 2. Cost data from study researchers: cost of delivery of training to pharmacy st | — |
Countries
United Kingdom
Outcome results
None listed