Background
The problem being addressed
Smoking prevalence in ethnic minority communities
Rationale for this trial
Aims and study questions
Aim
Study questions
Methods
Study/design
Interventions
'Clinic only' (control)
'Clinic + outreach' (intervention)
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◦ Standard two-day SSA training delivered by HoB tPCT
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◦ Three-day health promotion training course delivered by HoB tPCT on exploring ways to promote well-being and health, and techniques involved in the planning, preparation and delivery of approaches.
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◦ Sessions given by primary care staff at the University of Birmingham on research skills, communication skills, the function of the NHS, the cultural context of the work, and discussion of the outreach role.
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◦ Undertake community engagement work to help increase awareness of smoking cessation services
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◦ Assist existing service providers with the delivery of stop smoking support and promotions
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◦ Provide stop smoking support and medication for people in non-clinic venues, e.g. workplaces, public buildings.
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◦ Raise awareness of the dangers associated with smoking and counsel smokers wishing to quit
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◦ Identify suitable quit dates (which may be based on key religious events such as a Friday congregational prayer, journey on Umrah or Hajj (pilgrimage to Mecca), or to coincide with the month of Ramadan, for example)
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◦ Highlight religious objections to smoking, where appropriate
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◦ Make available existing and custom-made literature, telephone (Asian QuitLine) and other support materials.
Randomisation
Number of areas | Bangladeshi and Pakistani population density | Bangladeshi and Pakistani population size | Study arm |
---|---|---|---|
2 | High* | <10,000 | Clinic only |
2 | High | <10,000 | Clinic + outreach |
2 | High | >10,000 | Clinic only |
2 | High | >10,000 | Clinic + outreach |
2 | Low** | <300 | Clinic only |
2 | Low | <300 | Clinic + outreach |
2 | Low | >300 | Clinic only |
2 | Low | >300 | Clinic + outreach |
Protecting against sources of bias and reducing contamination
Research question | Outcome measure | Data source |
---|---|---|
LSSS Dataset
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1. What is the rate at which the population of Pakistani and Bangladeshi male smokers will set a quit day with the stop smoking services in the intervention and control areas. | Recruitment rate is defined as the number of relevant population setting a quit day with the services as a fraction of all those estimated to have attempted to stop. | LSSS routine database |
2. What proportions of those setting a quit day in the intervention and control areas achieve prolonged abstinence from smoking at a) 4 weeks, b) 3 months and c) 6 months after the agreed quit day? | a) Number of quits (measured by self assessment questionnaire & CO monitoring) Total number of smokers* accessing LSSS b) & c) number of quits (measured by self assessment questionnaire & CO monitoring) | a) LSSS routine database b) & c) LSSS data collected specifically for the trial |
3. What is the likely degree of contamination of the intervention and control areas and the design effect that need to be considered when conducting sample size calculations for a definitive cluster randomised controlled trial? | The design effect from cluster randomisation will be calculated from the multilevel analysis. Contamination cannot be easily measured; however, we have external controls which will help indicate whether it is occurring. | |
4. What are the key components of the intervention as it develops and how do these components relate to the outcome measured by the rates of setting quit dates and abstinence among those setting quit dates? | Qualitative data | Focus groups with outreach workers Observation of management meetings Shadowing Analysis of outreach worker diaries End of project interviews with outreach workers |
5. What proportion of Pakistani and Bangladeshi male smokers that book an appointment with the stop smoking service attend the initial appointment and set a quit day in the intervention and control areas? | To be estimated from a sample of service providers records | SSA records LSSS Routine database |
Extended Dataset
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6. What smoking cessation treatments do Pakistani and Bangladeshi men use in the intervention areas, facilitated by outreach workers, and in the control areas, without such workers? | Numbers of clients choosing each available treatment option (e.g. NRT, Zyban etc) | LSSS Routine database Patient satisfaction questionnaire administered by LSSS 'Call to Quit' team |
7. What are the experiences of the services of the relevant groups in each of the trial arms and how satisfied are they? | Patient satisfaction | Patient satisfaction questionnaire administered by LSSS 'Call 2 Quit' team |
8. What proportions of those enrolled adhere to the interventions chosen? | Numbers using oral tobacco during quit attempt (self report) Number of people adhering to each medication used in each arm of the trial (self report) Attendance at clinic in each arm of the trial | Adherence rating week by week then averaged, collected by SSA on extended data monitoring form |
9. What impact, if any, are these interventions likely to have on smokeless (oral) tobacco use in these smokers? | Numbers using oral tobacco during quit attempt (self report) | Frequency rating week by week, collected by SSA on extended data monitoring form Frequency of use of oral tobacco during this quit attempt rating on Patient satisfaction questionnaire administered by LSSS 'Call to Quit' team |
10. What are the costs, from a health service perspective, of delivering these interventions? | Estimated benefits of the intervention in terms of QALYs or LYGs. | Additional costs to NHS of (i) Employment, training, management of outreach workers- (ii) Extra resources used by LSSS – e.g. medication, behavioural support (Calculated from estimates of extra time used) |
Local Stop Smoking Service (LSSS) Dataset
Inclusion criteria
Exclusion criteria
Consent
Losses to follow-up
Extended Dataset
Recruitment
Inclusion criteria
Exclusion criteria
Consent
Losses to follow-up
Embedded qualitative work
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◦ Define more clearly the role of the outreach worker in assisting Bangladeshi and Pakistani smokers to stop smoking
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◦ Explore the approaches taken when recruiting service users and supporting smoking cessation and why they chose those particular approaches
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◦ Understand how the service provided changes over time, as their role, and what does and does not work, becomes clearer.
Risks to the safety of service users in the trial
Outcome measures and analysis
Proportion of people attending but not setting quit dates
Denominator for the proportion of smokers setting quit dates
Area number | Number of Pharmacies | Numbers using any LSSS service 06/07 | Number of smokers using LSSS within area they live | Number of smokers using LSSS in other areas of randomisation | Number of smokers* using LSSS users out of study zone | Number of smokers using unidentified LSSS |
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1 | 0 | 7 | 0 | 0 | 7 | 0 |
2 | 1 | 10 | 1 | 0 | 9 | 0 |
3 | 0 | 29 | 0 | 8 | 20 | 1 |
4 | 3 | 79 | 41 | 4 | 32 | 2 |
5 | 5 | 155 | 57 | 2 | 77 | 19 |
6 | 4 | 136 | 43 | 5 | 84 | 4 |
7 | 6 | 98 | 55 | 0 | 42 | 1 |
8 | 2 | 6 | 0 | 1 | 5 | 0 |
9 | 1 | 2 | 0 | 0 | 2 | 0 |
10 | 0 | 4 | 0 | 0 | 3 | 1 |
11 | 0 | 8 | 0 | 5 | 3 | 0 |
12 | 0 | 3 | 0 | 0 | 3 | 0 |
13 | 0 | 11 | 0 | 8 | 2 | 1 |
14 | 1 | 8 | 0 | 3 | 5 | 0 |
15 | 0 | 2 | 0 | 0 | 2 | 0 |
16 | 0 | 5 | 0 | 0 | 5 | 0 |
Definition and modelling of abstinence rates
Smoking cessation treatments chosen
Patient experiences
Estimating adherence
Estimation of costs
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◦ The employment, training, and management of the outreach workers
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◦ The extra resources used, including extra medication, extra behavioural support given by other providers as a result of additional activity generated by the outreach workers. We will calculate this from the economic costs to the NHS estimated from time used and/or observations of extra time taken.