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 use, clinical guidelines support behavioral therapy and pharmacotherapy as preferred interventions for tobacco cessation. The evidence-based behavioral interventions has consistently shown to be impactful in community settings; however, its efficacy has not been established in hospital settings. The current study aims to investigate impact of trans-theoretical-based behavioral intervention package on tobacco users suffering from non-communicable diseases attending tertiary care settings of North India. Methods/design A two-arm randomized controlled trial (RCT) in a tertiary healthcare hospital will be performed. A total of 360 tobacco users attending NCD clinics in four departments, cardiology, neurology, pulmonary medicine, and ENT (otolaryngology), will be recruited over a period of 3 months. After ascertaining the eligibility criteria, they will be followed up to 6 months (1, 3, 6) for their tobacco use status, readiness to quit, nicotine dependence, stage of behavior change, and self-reported and biochemical validation (urine cotinine) for tobacco abstinence. Assignment of intervention including allocation concealment, sequence generation, and blinding will be done as per SPIRIT guidelines for RCT protocols. Discussion As no strong evidence exists about the effectiveness of tobacco cessation intervention in tertiary settings, the current study will build evidence about the similar interventions in such settings. Trial registration CTRI/2019/09/021406.

Empowering tobacco users for improving outcomes: The transformative potential of shared decision making in tobacco cessation

“…Despite commendable efforts to reduce tobacco use over the last half‐century, around 1.3 billion people still continue to consume tobacco products annually, resulting in more than 8 million fatalities worldwide 1 . Tobacco usage and exposure cause premature death and illness globally 2 .…”

“…Despite commendable efforts to reduce tobacco use over the last halfcentury, around 1.3 billion people still continue to consume tobacco products annually, resulting in more than 8 million fatalities worldwide. 1 Tobacco usage and exposure cause premature death and illness globally. 2 While there are several methods to help people stop smoking and get the health benefits that come with doing so, most smokers either relapse or needed sustained intervention for maintaining quit status.…”