Study protocol to assess the effectiveness of pharmacistmanaged stop-smoking services : A randomized controlled trial

Abstract

According to the Global Adult Tobacco Survey (GATS), there were 267 million tobacco users in India during 2016–2017. It is also estimated that about one million people die each year due to tobacco-related diseases in India. Tobacco cessation is the only way by which tobacco-related morbidity and mortality can be avoided. Healthcare workers are ideal professionals to encourage smoking cessation, and pharmacists are the most accessible healthcare providers who can initiate a change in the smoking behavior of patients. Many studies, worldwide, have demonstrated the effectiveness of pharmacists in delivering a smoking cessation program, but studies demonstrating the effectiveness of pharmacist-managed smoking cessation services in India are almost non-existent. This protocol aims to test the effectiveness of Pharmacist-Managed Stop Smoking Services (PM-S3), a structured smoking cessation program delivered by a clinical pharmacist. A prospective, randomized, controlled trial is being conducted at a 550-bed tertiary care hospital in Coimbatore, India. Participants are randomly assigned to either an interventional group, where they receive at least four sessions of face-to-face, patient-specific, structured smoking cessation counselling by a clinical pharmacist for approximately 30 minutes each, or to usual-care group where they receive brief smoking cessation counseling by a physician and/or nurse. Both groups are provided with nicotine replacement therapy, if warranted. The primary outcome of smoking cessation is measured in two ways, viz self-reported abstinence and an exhaled carbon monoxide (CO) test. If proven effective, this model can be used as a framework for establishing pharmacist-managed stop smoking clinics in all hospitals throughout India to decrease the overall smoking burden.

Keywords

• smoking cessation
• pharmacist
• india
• nicotine dependence