A training and service intervention to optimise pharmacist-based treatment for smoking cessation

ISRCTN	ISRCTN16351033
DOI	https://doi.org/10.1186/ISRCTN16351033
Protocol serial number	33564
Sponsor	Queen Mary University of London
Funder	NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0609-10181

Submission date: 26/03/2018
Registration date: 03/04/2018
Last edited: 14/11/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Community pharmacists and 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 tests whether a service improvement and training programme (called the STOP intervention) for pharmacy staff will improve the uptake and reduce dropouts in the NHS Stop Smoking Programme and improve quit rates.

Who can participate?
Current smokers aged 18 and over

What does the study involve?
The participating community pharmacies are randomly allocated to either the STOP intervention or to usual practice. STOP involves training for pharmacy staff and associated study materials (e.g. badges, posters). Usual practice involves only NCSCT training (Level 1 or Level 2 depending on staff experience). Smoker recruitment into the NHS stop smoking programme and quit rates are assessed at 4 weeks and continuous abstinence is assessed at 6 months.

What are the possible benefits and risks of participating?
Participating may improve smoker quit rates. There is no risk for those taking part in the study.

Where is the study run from?
1. 29 pharmacies recruited from the following five boroughs in London: Tower Hamlets, Newham, City & Hackney, Islington, Barking & Dagenham (UK)
2. 19 pharmacies recruited from Coventry (UK)
3. 12 pharmacies recruited from Wales (UK)

When is the study starting and how long is it expected to run for?
May 2017 to August 2019

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Wai Yee James

Contact information

Ms Wai Yee James
Scientific

STOP Trial Manager
Blizard Institute
Yvonne Carter Building
58 Turner Street
London
E1 2AB
United Kingdom

ORCID ID	0000-0002-7954-9447

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment, Education or Self-Management, Complex Intervention
Secondary study design	Cluster randomised trial
Participant information sheet	ISRCTN16351033_PIS_V1.3_21Mar17_ServiceUser.doc
Scientific title	A training and service intervention to optimise pharmacist-based treatment for smoking cessation: a cluster randomised controlled trial
Study acronym	STOP
Study objectives	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). The trialists 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.
Ethics approval(s)	South Central - Hampshire A Research Ethics Committee, 03/04/2017, ref: 17/SC/0067
Health condition(s) or problem(s) studied	Specialty: Primary care, Primary sub-specialty: Public Health; UKCRC code/ Disease: Other/ General symptoms and signs
Intervention	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 continuous abstinence at six months. The community pharmacies (the cluster level) will be randomised to STOP training and service optimization intervention arm or usual care using stratified randomisation. The randomisation will be at the pharmacy level with 1:1 allocation ratio. Intervention STOP is a complex 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. Usual practice 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).
Intervention type	Other
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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 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
Completion date	01/08/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	1320
Total final enrolment	1272
Key inclusion criteria	NHS SSP eligibility criteria: 1. Current smokers aged 18 and above 2. All types of smoking (cigarettes, cigar, pipe)
Key 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
Date of first enrolment	30/05/2017
Date of final enrolment	03/01/2019

Locations

Countries of recruitment

United Kingdom

Study participating centres

29 pharmacies recruited from the following five boroughs in London: Tower Hamlets, Newham, City & Hackney, Islington, Barking & Dagenham

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United Kingdom

19 pharmacies recruited from Coventry

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United Kingdom

12 pharmacies recruited from Wales

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United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in repository
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/05/2019		Yes	No
Results article		28/06/2022	28/06/2022	Yes	No
Protocol article		10/06/2019	10/05/2024	Yes	No
HRA research summary			26/07/2023	No	No
Other publications	Pilot study results	10/01/2017	14/11/2024	Yes	No
Participant information sheet	version V1.3	21/03/2017	03/04/2018	No	Yes
Participant information sheet	version V1.3	21/03/2017	03/04/2018	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN16351033_PIS_V1.3_21Mar17_ServiceUser.doc: Uploaded 03/04/2018
ISRCTN16351033_PIS_V1.3_21Mar17_PharmacyStaff.doc: Uploaded 03/04/2018

Editorial Notes

14/11/2024: Publication reference added.
10/05/2024: Publication reference added.
28/06/2022: Publication reference and total final enrolment added.
19/05/2020: Publication reference added.