Effects of active referral combined with a small financial incentive on smoking cessation: study protocol for a cluster randomised controlled trial

Xue Weng, Man Ping Wang, Ho Cheung William Li, Yee Tak Derek Cheung, Ching Yin Lau, Antonio Cho Shing Kwong, Vienna Wai Yin Lai, Sophia Siu Chee Chan, Tai Hing Lam, Xue Weng, Man Ping Wang, Ho Cheung William Li, Yee Tak Derek Cheung, Ching Yin Lau, Antonio Cho Shing Kwong, Vienna Wai Yin Lai, Sophia Siu Chee Chan, Tai Hing Lam

Abstract

Introduction: Evidence-based smoking cessation treatments are effective but underutilised, accentuating the need for novel approaches to increase use. This trial investigates the effects of active referral combined with a financial incentive to use smoking cessation services on smoking abstinence among community smokers.

Methods and analysis: This ongoing study is a two-arm, assessor-blinded, pragmatic, cluster randomised controlled trial with follow-ups at 1, 2, 3 and 6 months after randomisation. We aim to enrol 1134 daily smokers from 70 community sites (clusters) in Hong Kong. All participants receive Ask, Warn, Advise, Refer, Do-it-again (AWARD) guided advice and a self-help booklet at baseline. Additionally, participants in the intervention group receive an offer of referral to smoking cessation services at baseline and a small financial incentive (HK$300≈US$38) contingent on using any of such services within 3 months. The primary outcomes are bioverified abstinence (exhaled carbon monoxide <4 ppm and salivary cotinine <10 ng/mL) at 3 and 6 months. Secondary outcomes include self-reported 7-day point prevalence of abstinence, smoking reduction rate, quit attempts and the use of smoking cessation services at 3 and 6 months. Intention-to-treat approach and regression models will be used in primary analyses.

Ethics and dissemination: This protocol has been approved by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (IRB reference number: UW 18-318). The results of this trial will be submitted for publication in peer-reviewed journals, and the key findings will be presented at national and international conferences.

Trial registration number: ClinicalTrials.gov Registry NCT03565796.

Keywords: clinical trials; protocols & guidelines; public health.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
CONSORT flow diagram. AWARD, Ask, Warn, Advise, Refer, Do-it-again; CONSORT, Consolidated Standards of Reporting Trials.

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