A randomized clinical trial of a financial education intervention with nicotine replacement therapy (NRT) for low socio-economic status Australian smokers: a study protocol

Background and Aims Reducing smoking prevalence among smokers from low socio-economic status (SES) is a preventative health priority. Financial stress (e.g. shortage of money or inability to pay bills) may be a major barrier to quitting smoking. This study evaluates the efficacy of a financial education and support programme coupled with pharmacotherapy at improving cessation rates at 8-month follow-up among Australian low SES smokers (people receiving a government pension or allowance). Design A two-group parallel block randomized (ratio 1:1) open-label clinical trial (RCT) with allocation concealment will be conducted. Allocation will be concealed to interviewers at data collection-points. Setting The study will be conducted primarily by telephone with baseline, follow-up interviews and telephone-based support sessions. Nicotine replacement therapy (NRT) delivery will be mail-based. Participants Daily smokers who are interested in quitting smoking and are currently in receipt of government benefits (n=1046) will be recruited through study advertisements placed in newspapers, posters placed in government social assistance agencies and Quitline telephone-based cessation support services. After completion of a baseline computer-assisted telephone interview, participants will be allocated randomly to control or intervention group using a permuted block approach. Intervention and Comparator Participants in both groups will receive 8 weeks of free combination NRT plus Quitline support. Participants in the intervention group will also receive four telephone-delivered financial education and support sessions. Measurements The primary outcome measure will be prolonged abstinence (at 8-month follow-up) assessed using Russell Standard criteria and biochemically verified (urine cotinine). Comments This is the first intervention study to evaluate the potential of co-managing financial stress as a means of enhancing smokers' capacity to quit smoking. Such an intervention may provide a scalable intervention to help low SES smokers to quit.