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Abstract
Background Tobacco use is a major risk factor for recurrent stroke. The provision of cost-free quit smoking medications has been shown to be efficacious in increasing smoking abstinence in the general population.
Objective The objective of this pilot study was to assess the feasibility and obtain preliminary data on the effectiveness of providing cost-free quit smoking pharmacotherapy and counselling to smokers identified in a stroke prevention clinic.
Trial design Cluster randomised controlled trial.
Methods All patients seen at the Ottawa Hospital Stroke Prevention Clinic who smoked more five or more cigarettes per day, were ready to quit smoking in the next 30 days, and were willing to use pharmacotherapy were invited to participate in the study. All participants were advised to quit smoking and treated using a standardised protocol including counselling and pharmacotherapy. Participants were randomly assigned to either a prescription only usual care group or an experimental group who received a 4-week supply of cost-free quit smoking medications and a prescription for medication renewal. All patients received follow-up counselling. The primary outcome was biochemically validated quit rates at 26 weeks. The research coordinator conducting outcome assessment was blind to group allocation.
Results Of 219 smokers screened, 73 were eligible, 28 consented and were randomised, and 25 completed the 26-week follow-up assessment. All 28 patients randomised were included in the analysis. The biochemically validated 7-day point prevalence abstinence rate in the experimental group compared to the usual care group was 26.6% vs 15.4% (adjusted OR 2.00, 95% CI 0.33 to 13.26; p=0.20).
Conclusions It would be feasible to definitively evaluate this intervention in a large multi-site trial.
Trial registration number http://ClinicalTrials.gov # UOHI2010-1.
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Footnotes
To cite: Papadakis S, Aitken D, Gocan S, et al. A randomised controlled pilot study of standardised counselling and cost-free pharmacotherapy for smoking cessation among stroke and TIA patients. BMJ Open 2011;1:e000366. doi:10.1136/bmjopen-2011-000366
Funding No external funding was received for the completion of this pilot study. The two collaborating healthcare/research institutions involved in this study, the Minto Prevention and Rehabilitation Centre at the University of Ottawa Heart Institute and the Champlain Stroke Prevention Clinic provided in-kind resources to allow for the completion of the trial including the cost of the cost-free pharmacotherapy.
Competing interests The institutions and study authors at no time received payment or services from a third party for any aspect of the work submitted. The University of Ottawa Heart Institute has received research and education grant support from Pfizer Canada, Johnson and Johnson, and GlaxoSmithKline. AP has served as a consultant and has received speaker honoraria from Pfizer, Johnson and Johnson, and GlaxoSmithKline; RR has received speaker honoraria from Pfizer; DA has received speaker honoraria from Pfizer; and DR has served as a consultant to Pfizer.
Ethics approval The University of Ottawa Heart Institute Human Research Ethics Board provided ethics approval.
Contributors SP, DA, SG and RR provided substantial contributions to the conception, design, acquisition of data, analysis and interpretation of data, and drafting of the article. AP and MS contributed to the conception, design, interpretation of data and drafting of the article. DR, ML, AB, DC, DS and RE contributed to the acquisition of data, interpretation of results and drafting of the article. All authors approved the final version of the manuscript to be published.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The study database including participant characteristics and outcomes has been uploaded to the Dryad Digital Repository, doi:10.5061/dryad.p67jf576.