A Pragmatic Pilot Cluster-Randomized Study of Tobacco Screening and Smoking Cessation Program for Community Pharmacies in Japan: FINE Program

Mitsuko Onda; Michiko Horiguchi; Masayuki Domichi; Naoki Sakane

doi:10.1155/2021/9983515

A Pragmatic Pilot Cluster-Randomized Study of Tobacco Screening and Smoking Cessation Program for Community Pharmacies in Japan: FINE Program

J Smok Cessat. 2021 Dec 3:2021:9983515. doi: 10.1155/2021/9983515. eCollection 2021.

Authors

Mitsuko Onda¹, Michiko Horiguchi², Masayuki Domichi³, Naoki Sakane³

Affiliations

¹ Department of Social and Administrative Pharmacy, Osaka Medical and Pharmaceutical University, Osaka 569-1094, Japan.
² Cocokara Fine Healthcare Inc., Kansai branch, Osaka 542-0081, Japan.
³ Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto 612-8555, Japan.

Abstract

Objectives: To investigate the effectiveness of a smoking cessation program (FINE program) in community pharmacies.

Methods: A cluster-randomized controlled trial was conducted in 11 community pharmacies in Japan. The participants were randomly assigned to a pharmacist-led structured smoking cessation program (intervention group) or pharmacist-led usual care (control group). The intervention group was followed up over the telephone on the third day of smoking cessation, and ongoing follow-up and advice were provided according to the original smoking cessation guidebook developed for the current study based on a behavioral change approach. The control group received brief advice and ready-made pamphlets on smoking cessation from pharmacists upon their visit to these community pharmacies. The primary outcome was continued smoking cessation as determined by self-reporting and carbon monoxide monitoring with a microsmokerlyzer after 3 months.

Results: Five hundred and seventy-two smokers who met the eligibility criteria visited the pharmacies included in the study. Of these individuals, 24 patients agreed to participate in the study. The quit rates were 45.5% and 18.2% in the intervention and control groups, respectively (P = 0.380, effect size = 0.60).

Conclusion: Based on the effect size values, the FINE program may be effective to some extent, but the difference was not significant. We speculate that this is related to the small sample size due to difficulty in recruiting. Further studies with an effective recruitment method and larger sample sizes are needed to accurately verify the effectiveness of this program.