Comparing different intensities of active referral to smoking cessation services in promoting smoking cessation among community smokers: a study protocol of a cluster randomized controlled trial

Abstract

Abstract Background Actively referring smokers to smoking cessation (SC) services could increase quitting and is scalable for the population. The objective of this study is to compare 2 different intensities of SC active referral for smokers in the community of Hong Kong. Methods/design This is a single-blind, parallel 3-armed cluster randomized controlled trial (cRCT) consisting of high-intensity SC active referral (HAR Group), low-intensity SC referral by text messaging on promoting SC services use (Text Group) and a control group receives general very brief advice. Biochemically validated daily smokers will be proactively recruited in the community from 68 clusters (recruitment sessions). The primary outcome is self-reported 7-days point prevalence abstinence (PPA) at the 3- and 6- month follow-ups. Secondary outcomes are SC service use, smoking reduction rate (SRR, daily cigarette consumption reduced by ≥50%; excluding quitters) and biochemically validated quit rate (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml). Outcome assessors and data analysts will be blinded to group allocation. Intention-to-treat principle and Generalized Estimating Equation (GEE) regressions will be used for data analysis. Discussion This will be the first trial on evaluating the efficacy of the 2 different intensities of SC active referral on smoking cessation in community smokers. It is anticipated that the results from this trial can provide evidence to the effectiveness of high-intensity active referral to SC services and low intensity SC referral by using text messaging in achieving smoking abstinence. Trial registration ClinicalTrials.gov Identifier: NCT02804880, June 17, 2016.

Keywords

• Smoking cessation
• Active referral
• Community smoker
• Randomized controlled trial