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A pragmatic, randomized, controlled study evaluating the impact of access to smoking cessation pharmacotherapy coverage on the proportion of successful quitters in a Canadian population of smokers motivated to quit (ACCESSATION).

ABSTRACT: Many smokers find the cost of smoking cessation medications a barrier. Financial coverage for these medications increases utilization of pharmacotherapies. This study assesses whether financial coverage increases the proportion of successful quitters.A pragmatic, open-label, randomized, controlled trial was conducted in 58 Canadian sites between March 2009 and September 2010. Smokers (?10 cigarettes/day) without insurance coverage who were motivated to quit within 14 days were randomized (1:1) in a blinded manner to receive either full coverage eligibility for 26 weeks or no coverage. Pharmacotherapies covered were varenicline, bupropion, or nicotine patches/gum. Investigators/subjects were unblinded to study group assignment after randomization and prior to choosing a smoking cessation method(s). All subjects received brief smoking cessation counseling. The primary outcome measure was self-reported 7-day point prevalence of abstinence (PPA) at week 26.Of the 1380 randomized subjects (coverage, 696; no coverage, 684), 682 (98.0%) and 435 (63.6%), respectively, were dispensed at least one smoking cessation medication dose. The 7-day PPA at week 26 was higher in the full coverage versus no coverage group: 20.8% (n?=?145) and 13.9% (n?=?95), respectively; odds ratio (OR)?=?1.64, 95% confidence interval (CI) 1.23-2.18; p?=?0.001. Urine cotinine-confirmed 7-day PPA at week 26 was 15.7% (n?=?109) and 10.1% (n?=?69), respectively; OR?=?1.68, 95% CI 1.21-2.33; p?=?0.002. After pharmacotherapy, coverage eligibility was withdrawn from the full coverage group, continuous abstinence between weeks 26 and 52 was 6.6% (n?=?46) and 5.6% (n?=?38), in the full coverage and no coverage groups, respectively; OR?=?1.19, 95% CI 0.76-1.87; p?=?0.439.In this study, the adoption of a smoking cessation medication coverage drug policy was an effective intervention to improve 26-week quit rates in Canada. The advantages were lost once coverage was discontinued. Further study is required on the duration of coverage to prevent relapse to smoking. (clinicaltrials.gov identifier: NCT00818207; the study was sponsored by Pfizer Inc.).

SUBMITTER: Selby P

PROVIDER: S-EPMC4022549 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature

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A pragmatic, randomized, controlled study evaluating the impact of access to smoking cessation pharmacotherapy coverage on the proportion of successful quitters in a Canadian population of smokers motivated to quit (ACCESSATION).

Selby Peter P Brosky Gerald G Oh Paul P Raymond Vincent V Arteaga Carmen C Ranger Suzanne S

BMC public health 20140507

<h4>Background</h4>Many smokers find the cost of smoking cessation medications a barrier. Financial coverage for these medications increases utilization of pharmacotherapies. This study assesses whether financial coverage increases the proportion of successful quitters.<h4>Methods</h4>A pragmatic, open-label, randomized, controlled trial was conducted in 58 Canadian sites between March 2009 and September 2010. Smokers (≥10 cigarettes/day) without insurance coverage who were motivated to quit wit ...[more]

PMID: 24885542

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Project description:Objective To examine whether cost-free (CF) smoking cessation medication was more effective than a prescription for cessation medication in patients after transient ischaemic attack (TIA) or stroke. Design Two-site randomised trial. Setting Stroke prevention clinics (SPCs) in Ontario, Canada. Participants Smokers with TIA or stroke, willing to quit smoking. Intervention Smoking status was assessed in SPC attendees. Smokers were advised to quit smoking and received recommendations for cessation medication and counselling. Consenting participants were randomly assigned (1:1) to either a CF medication group or a prescription-only (Rx) group. CF participants immediately received a 12-week supply of cessation medication. Rx participants were given a prescription for 12 weeks of cessation medication. Follow-up counselling was provided for 26 weeks. Main outcome The primary outcome was 40-week continuous abstinence verified using a carbon monoxide breath test at 52-week follow-up. Secondary outcomes included abstinence at intermediate timepoints, medication adherence and serious adverse events. Results Hundred and ninety-four participants were randomised and 131 (67.5%) completed the trial. The 40-week continuous abstinence rate at 52-week follow-up was 15.5% in the CF group versus 14.0% in the Rx group (OR=1.13; 95% CI 0.51 to 2.53). The 14-week continuous abstinence rate at 26-week follow-up was 18.6% in the CF group versus 16.8% in the Rx group (OR=1.20; 95% CI 0.56 to 2.55). Seven-day point-prevalence abstinence at 12 weeks was 38.1% in the CF group versus 26.9% in the Rx group (OR=1.76; 95% CI 0.94 to 3.28). Medication adherence was higher in the CF group versus the Rx group (47.4%±41.2% vs 25.5±36.8%, p<0.001). Serious adverse events occurred in 11.1% of participants and were unrelated to treatment. Conclusions Our findings were inconclusive; we failed to meet our recruitment target and the effect size was smaller than anticipated. CF medication improved medication adherence. Trial registration number NCT00962988; ClinicalTrials.gov Identifier.

Dataset Information

A pragmatic, randomized, controlled study evaluating the impact of access to smoking cessation pharmacotherapy coverage on the proportion of successful quitters in a Canadian population of smokers motivated to quit (ACCESSATION).

Publications

A pragmatic, randomized, controlled study evaluating the impact of access to smoking cessation pharmacotherapy coverage on the proportion of successful quitters in a Canadian population of smokers motivated to quit (ACCESSATION).

Similar Datasets

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