Condition category
Mental and Behavioural Disorders
Date applied
26/03/2018
Date assigned
03/04/2018
Last edited
03/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Ms Wai Yee James

ORCID ID

http://orcid.org/0000-0002-7954-9447

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33564

Study information

Scientific title

A training and service intervention to optimise pharmacist-based treatment for smoking cessation: a cluster randomised controlled trial

Acronym

STOP

Study hypothesis

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

South Central - Hampshire A Research Ethics Committee, 03/04/2017, ref: 17/SC/0067

Study design

Randomised; Interventional; Design type: Treatment, Education or Self-Management, Complex Intervention

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

See additional files

Condition

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

Phase

Drug names

Primary outcome measure

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 outcome measures

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

Overall trial start date

15/05/2017

Overall trial end date

01/08/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

NHS SSP eligibility criteria:
1. Current smokers aged 18 and above
2. All types of smoking (cigarettes, cigar, pipe)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1320; UK Sample Size: 1320

Participant 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

Recruitment start date

30/05/2017

Recruitment end date

03/01/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Trial participating centre

19 pharmacies recruited from Coventry
-

Trial participating centre

12 pharmacies recruited from Wales
-

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

c/o Dr Sally Burtles
Joint Research Management Office
Queen Mary Innovation Centre
5 Walden Street
London
E1 2EF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0609-10181

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository.

Intention to publish date

01/08/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Editorial Notes