To explain behavior change, many behavioral change theories, like the Health belief model41, Socio-cognitive theory42, and Trans-theoretical framework43, are being used, focusing upon different factors. The current study will consider the Trans-theoretical framework to address the change in behavior towards tobacco cessation after providing an intervention. This framework is used for following reasons: Firstly, this helps to assess an individual's readiness to act on a new healthier behavior. Secondly, it provides strategies or processes of change to guide the individual. Third, this framework will also emphasize the importance of tobacco users' motivation and self-efficacy while considering the barriers to change and cues to action. Studies worldwide using Trans-Theoretical Model (TTM) to track tobacco use behavior have established its validity and reliability across various settings.44–48 Further, this framework will help clinicians track tobacco users' movement from one stage to the next stage.49
The tobacco cessation intervention (TCI), brief and intensive being cost-effective, has variably shown the effectiveness and efficacy of reducing ill health and increasing Quality-Adjusted Life Years (QALY). A systematic review50 concluded the cost-effectiveness of intensive over brief tobacco cessation intervention with 960 & 280 discounted cumulative number of QALYs per year gained in the two interventions. Further studies documented intensive tobacco cessation intervention in reducing ill-health, morbidity, and mortality compared to brief intervention.51 As no evidence could be reported on the comparative effectiveness of intensive over the brief intervention for tobacco cessation in the Indian hospital setting, the results of current study will provide quality evidence to replicate the protocol in similar settings across the globe.
Despite the strong evidence about the effectiveness of tobacco cessation intervention in community settings, its implementation by health professionals in tertiary care is still not explored. Tobacco-related diseases are one of the main reasons for all general hospital admissions.52 During hospital stays, these patients should be advised to stop tobacco use because this decision has been related to reductions in morbidity and mortality.53 Although many health care delivery centers restrict or prohibit patients from tobacco use to protect other patients and staff from the effects of passive smoking. This tobacco-free environment may provide an opportunity for hospitalized patients to attempt abstaining from its use.
Nevertheless, the use of intervention for cessation has been frequently ignored by health professionals in hospitalized populations and often discharge patients from tertiary care without sufficiently addressing opportunities for tobacco prevention.54, 55 For this reason, providing (or at least initiating) tobacco dependence treatments in hospitals may be an effective preventive health strategy.56, 57 To our knowledge, no study in an Indian setting has investigated the effects of tobacco-cessation intervention in a subset of patients admitted in a tertiary healthcare delivery center. Thus, the study will build evidence on the effectiveness of interventions in such settings and advocate for a tailored intervention.
Most of the existing studies relied on questionnaire methods such as Russell Standard for self-reporting abstinence rather than biochemical verification to measure tobacco use status. The biochemical verification shall increase rigor and validity compared to self-reported tobacco abstinence. However, it also has limitations, including the inability to confirm long-term abstinence, implementation challenges, and high performance cost. Thus, the current study will confirm the self-reported status biochemically at the end of the trial to overcome this.
Besides, the planned study has several strengths and endeavors to strengthen the theoretical framework for tobacco cessation interventions. Firstly, this will be the first comprehensive study from India conducted in tertiary care setting comparing intensive with brief intervention for tobacco cessation. Secondly, it will use a holistically designed intervention developed after obtaining all stakeholders' views, including tobacco users. Thirdly, it shall examine the effect of tobacco cessation intervention after one, three, and six months of providing intervention, which will provide an opportunity to evaluate long-term treatment effects on tobacco abstinence. At last, verification of quitting status with cotinine assessment will strengthen the validation of outcomes. A few limitations of the study include the possibility of missing data throughout the follow-up period influencing the validity and internal reliability of the results. However, this is a frequent phenomenon of any long-term trial involving tobacco cessation. Also, the results may not be generalized for the general population as the participants will be from the hospital settings in the study. Moreover, the effect of Secondhand Smoke (SHS) in the measurement could not be ascertained.
Dissemination of results:
The evidence generated on the effectiveness of tobacco cessation intervention in India's tertiary care setting will be published in a good impact journal for more comprehensive readability. It will also help policymakers, implementers, and educators use the current tobacco cessation intervention package to design a plan and assist tobacco users in quitting tobacco.
Recruitment of participants started in December 2020 and is currently ongoing. The study findings are expected to be available in August 2022.