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.

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.