Comparative Effectiveness of Two Behavioral Change Intervention Packages for Tobacco Cessation Initiated in the Tertiary Care Setting of North India-Protocol for a Two-Arm Randomized Controlled Trial

Abstract

Background: To reduce the global burden of tobacco, clinical guidelines support behavioral and pharmacotherapy as preferred intervention for tobacco cessation. While behavioral intervention such as advice from health care provider with brief or intensive intensity has consistently shown to be impactful compared to no intervention. The current study aims to investigate efficacy of a behavioral intervention package on patients attending tertiary care setting for change in tobacco cessation behavior.Methods/Design: A two arm randomized controlled trial shall be performed to ascertain the differential impact of various behavioral change approaches on the tobacco use status of patients in hospital settings. 574 patients fulfilling the eligibility criteria shall be included for the intervention of 3 months duration and shall be followed for a period of 12 months. To validate the self-reported tobacco abstinence urinary cotinine assessment will be performed. Discussion: As no strong evidence exists about the effectiveness of tobacco cessation intervention in tertiary settings, thus the feasibility of its implementation by health professionals in these settings is a matter of concern. Therefore, the current study will build evidence about the feasibility of interventions in such settings. Trial Registration: CTRI/2019/09/021406