ISRCTN16351033.

Trial name or title	STOP study
Methods	Country: United Kingdom Design: Cluster‐randomised controlled trial Study objective: To test whether a service improvement and training programme (called the STOP intervention) for pharmacy staff will improve the uptake and reduce dropouts in the National Health Service (NHS) Stop Smoking Programme and improve quit rates Method of analysis: Not reported Clustering adjustments made: Community pharmacists (the cluster level) will be randomised; no mention of adjustments for clustering, though number of smokers attending a treatment session and setting a quit date is the primary outcome
Participants	Intended to randomise: n = 60 pharmacies with 1320 smokers Age: 18 and over to be recruited Gender: Not reported Inclusion criteria: Current smokers aged 18 and above; All types of smoking (cigarettes, cigar, pipe) 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
Interventions	Setting: Community pharmacies Intervention description: STOP intervention ‐ "based on behavioural theory involving training for pharmacy staff and associated study materials (e.g. badges, posters). The intervention training focuses on team approach in delivering the NHS STOP smoking service. " Control description: "The National Centre for Smoking Cessation and Training (NCSCT) offers a range of training, assessment and certification programmes for both clinical and non‐clinical health and social care workers to become more skilled in smoking cessation. Control pharmacies will only receive NCSCT training (Level 1 or Level 2 depending on staff experience)." Duration of intervention: At least 1 stop‐smoking session with a community pharmacist, but it is unclear if there are additional sessions
Outcomes	Prespecified outcomes: Primary outcome: number of smokers who join the NHS Stop Smoking Program (SSP), attend a treatment session and set a firm date (i.e. a treated smoker); Secondary outcomes: 4‐week retention rate, defined as proportion of treated smokers retained at 4 weeks; 4‐week quit rate, defined as proportion of smokers who quit smoking at 4 weeks from set quit date, i.e. a "carbon monoxide (CO)‐verified 4‐week quitter"; Continuous abstinence rate, defined as proportion of smokers who quit at 4 weeks (CO‐verified) and remained so at 6 months; Effect of the training intervention on additional (routine) data provided by the consented service users; Additional process outcomes include: Satisfaction about the NHS SSP by questionnaire; Self‐efficacy in smoking cessation delivery by questionnaire; 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; Intervention training attendance and completion rates, reasons for non‐attendance and dropout; Acceptability of intervention training and delivery in practice by questionnaire; Delivery of skills in practice at the pharmacy counter around engagement of service users into the NHS SSP by simulated client using checklist; Skills around retention of service users in pharmacy consultation room by audio‐recording of consultations; Views and experiences about the STOP training and its delivery in practice; 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 included: 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; Cost data from study researchers: cost of delivery of training to pharmacy staff and costs associated with delivery of training such as travel expenses, refreshments, room hire, use of printed materials, use of assistive technology; provision of financial incentive; attending feedback meeting with trainer Follow‐up period: 4‐week quit rates and 6 months continuous abstinence
Starting date	May 2017 to August 2019
Contact information	Ms Wai Yee James; STOP Trial Manager; Blizard Institute; Yvonne Carter Building; 58 Turner Street, London, E1 2AB; United Kingdom
Notes	Funding: National Institute for Health Research (NIHR) Central Commissioning Facility (CCF); Grant Codes: RP‐PG‐0609‐10181 Study registration: ISRCTN16351033 Declarations of interest: none stated