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

doi:10.21203/rs.3.rs-511488/v2

ackground:

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 health care hospital will be performed. A total of 360 tobacco users attending NCD clinics in four departments: Cardiology, Neurology, Pulmonary Medicine, ENT (Otolaryngology) will be recruited over a period of three 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 & biochemical validation (urine cotinine) for tobacco abstinence. Assignment of intervention including allocation concealment, sequence generation, 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

Behavioral therapy

tobacco cessation

tertiary care setting

randomized controlled trial

Despite laudable actions against tobacco use for over 50 years, around 1.3 billion people still use tobacco¹, causing more than 8 million deaths each year globally² India alone shares the burden of 267 million tobacco consumers³, causing 1.2 million people deaths from smoking and exposure to secondhand smoke (SHS).⁴ Further, 2,30,000 deaths result from the use of smokeless tobacco each year.⁵ The health consequences of severe tobacco addiction and increased tobacco consumption are tremendous.^6,7 In particular, the rise of Non-communicable diseases (NCDs), including heart disease, stroke, cancer, diabetes, and chronic lung disease, is driven primarily by tobacco use. Findings^8–10 suggests that even quitting tobacco after NCD diagnosis improves survival and quality of life.

In order to combat the problem and reduce the tobacco burden, various targets have been established globally with the initiatives such as WHO Tobacco Free Initiative (1990), WHO framework convention on tobacco control (2003)¹¹, WHO MPOWER policy (2008)¹² and United Nation's Sustainable Development Goals (SDG) (2015).¹³ Similarly, the Government of India enacted the Cigarettes and Other Tobacco Products Act (COTPA)¹⁴ in 2003 to prohibit the advertisement of and regulate trade, commerce, production, supply, and distribution of cigarettes and other tobacco products. National Tobacco Control Program (NTCP) was then launched in the year 2008 to ensure effective implementation of COTPA.¹⁵

Furthermore, to better address tobacco use and dependence, with the implementation of policies transforming the health care system, equally important is promoting evidence-based treatment for tobacco cessation. Treatments including behavioral and pharmacotherapy have shown to be effective when used alone or in combination.^16–17 Studies also document that the healthcare providers' advice has been successful in 66% increase in quit rate than no intervention,¹⁸ and motivational interviewing was more effective than simply providing brief advice for tobacco cessation.^19–20 For the delivery of the different behavioral interventions, various modalities like web, mobile, telephone, posters, self-help materials, videos, and other sources have gained popularity in the last few decades.²¹ In-person delivery of these modalities individually or in combination provided at an ideal time, and a suitable place such as hospital support encourages patients to quit.²² Evidence also shows a higher rate of tobacco abstinence and significantly better outcomes from proactive telephone counseling than a self-help manual in hospital settings.²³

Besides, hospitalization increases perceived vulnerability to the harms of tobacco use, thereby motivating the tobacco users to quit. Further after discharge, patients are likely to continue with quitting behavior with positive reinforcement through regular follow-ups.²² Contrary, multiple challenges account for tobacco dependence treatment in hospital settings. Many clinicians do not consistently offer cessation services to patients due to lack of time, interest, low awareness about treatment, reference services²⁴, and lack of resources (drug, counselors, privacy).²⁵

While there is some evidence on the clinical and cost-effectiveness of behavioral change interventions for quitting tobacco^26–29, there is a lack of data on the effectiveness of these interventions in the tertiary health care setting. To our knowledge, merely two randomized controlled trials initiated in hospital settings comparing intensive with brief intervention have been documented so far on tobacco cessation^30–31, while no such study has been conducted in India. Moreover, earlier research investigated the self-reported change in behavior rather than biochemically verified quit rate using urinary cotinine or other parameters. Therefore current study plans to establish the evidence for implementing behavioral intervention among tobacco users suffering from major NCDs.

Objective:

To ascertain the differential impact of trans-theoretical model-based behavior change communication strategies for tobacco cessation among tobacco users suffering from non-communicable disease enrolled from tertiary health care settings in North India.

Study Design and Setting

The study will be a two-armed Randomized Controlled Trial (RCT) conducted in a tertiary care institute of North India.

The tertiary care health center is at the top level of the healthcare delivery system for the public, which provides specialized consultation care, usually on referral from primary and secondary medical care institutes. They include medical colleges and advanced medical research institutes owned and controlled by the central or state government. The study institute is India's premier medical and research institute, with state-of-the-art educational, medical research, and training facilities. It has a bed strength of 1960 across various departments. Four departments viz. Cardiology, Pulmonary Medicine, Neurology, and ENT (Otolaryngology) were purposively selected for the study as we expect maximum enrolment of NCD patients in these departments, which is required to assess the efficacy of the intervention. Apart from the OPD and inpatient services, these departments provide 24 hours emergency services and round-the-clock consultation services.

Study Participants

While there are no generally agreed-upon definitions of heavy tobacco user, intake of 20 cigarettes per day over 10–20 years, corresponding to 10–20 pack-years, has been associated with a clinically relevant increase in morbidity and is used in various studies.^6,7,32 Thus, considering the importance of quantifying tobacco exposure and its correlation to the risk of disease, the criteria of at-least ten pack-years for inclusion of participants, which establishes a baseline smoking or related tobacco products exposure³³, will be used for recruiting the participants visiting tertiary health care setting for study. The participants complying with the eligibility criteria will be informed about the study.

Inclusion, exclusion, and dropout/withdrawal criteria

Participants will be eligible provided they: (1) Are above 18 years of age, (2) Have a history of using tobacco for the last one month and at least ten pack-year or equivalent tobacco, (3) Can read and understand English, Hindi, or Punjabi, (4) Have a mobile phone with text messages/WhatsApp messages accessibility, (5) Are willing to quit and provide written consent for intervention and follow up of 6 months in the study.

Participants will be excluded if they: (1) Are unable to understand any of the languages as mentioned above, (2) Are severely ill to participate in the study and require urgent attention for any of the medical problems, (3) Are already taking treatment for tobacco cessation, and (4) Are mentally ill to accord informed consent for the study.

Participants will be discontinued for the study if they: (1) Voluntarily withdraw the consent, (2) Are not complying with the study schedule, (3) Are not in a condition to continue with the study due to migration or other reasons. The reason for withdrawal will be collected, and no more follow-up will be initiated. Participants who drop out of the study will be considered tobacco users.

Sample Size

Based on existing literature,⁴⁰ where tobacco abstinence rate of 16.8% and 30.3% has been reported in the control and intervention arm, respectively, and considering alpha level 0.05, and 15% dropout rate with the power of 0.80 (0%), a total sample size of 360 is estimated. Participants will be randomly assigned into two arms at a ratio of 1:1 with 180 in each arm. The trial with this sample size will have sufficient power to detect a clinically significant difference between the two arms. The planned sample size will be recruited in approximately three months and followed up for six months.

Assignment of Intervention

Sequence Generation

The participants meeting the inclusion criteria will be randomly assigned by the researcher to either control or intervention arm with a 1:1 allocation as per the randomization sequence generated in advance by a computer program. For ensuring a balanced representation of the participants in two groups from various departments, stratified block randomization with block sizes of four will be used.

Allocation Concealment

To ensure and prevent participants and researcher from knowing the study group to which the next participant will be assigned, concealment of allocation will be maintained using sequentially numbered, opaque sealed envelopes. One of the study members other than the researcher will create the allocation sequence in the opaque envelopes for assigning the intervention group, which the researcher will then open for participants' enrolment.

Implementation

Prior to opening envelopes, the eligibility of participants shall be assessed by the researcher. Eligible participants will then be informed about the trial and asked for their participation. After that, the interested participants will then be enrolled in the intervention arms and provided with the assigned intervention by the study researcher.

Blinding

The study will be single-blinded, where participants assigned to the intervention arm will only be blinded, while the person delivering the intervention and assessing the outcome ( researcher) will be aware of the intervention group to which participants have been assigned.

Intervention:

Intervention/ Treatment Arm

The significant intervention modalities for changing the behavior include face-to-face/individual counseling, telephonic counseling, patient information material in leaflet form, motivational videos, text messages, and the usual care provided in the health center.

The details of the intervention provided in Arm-1 (Brief intervention) and Arm-2 (Intensive intervention) are given in Table 1

Table 1: Behavior change communication intervention in the treatment arms for tobacco users suffering from NCDs in the tertiary care hospital of North India

*INTERVENTION ARM*	*MODE OF DELIVERY*	*PROVIDER*	*TIME DURATION & FREQUENCY*	*BENEFITS*
Brief & Intensive	Individual Counseling	Researcher	10-20 minutes of the session at ^firstcontact	Both minimal (< 20 minutes in 1 visit) and intensive (≥ 20 minutes plus > 1 follow-up visit) physician-advice interventions effectively increase the proportion of adults who successfully quit tobacco and remain abstinent for ≥ 6 months.⁸There is a dose–response relationship between the intensity of counseling and cessation rates (i.e., more or longer sessions improve cessation rates).³⁴
Brief & Intensive	Motivational videos	Researcher	3-5 minutes of video at ^firstcontact	Technology including mobile phones, the internet, and social media platforms, can increase access to care by extending the work of counselors and overcoming the geographical barriers. These supports can increase the likelihood of adults quitting compared with no intervention and can be a cost-effective adjunct to other treatments.³⁵
Brief & Intensive	Patient information leaflet (PIL)	Researcher	1 PIL at ^first contact	Providing self-help materials (primarily print-based) tailored to the individual patient (that is, beyond a brochure that simply describes the health effects of tobacco use and benefits of cessation) is effective in improving tobacco abstinence.³⁶
Intensive	Telephone counseling	Researcher	05-15 minutes of the session, five times at <1,4,6,9,12 week in 3 months after enrolment	Telephone-based access to counseling and smoking cessation resources increases cessation rates. The majority of help-lines provide access to individual counseling; the greatest amount of counselor contact, the greater the likelihood of successful cessation.³⁷
Intensive	Text messages using SMS	Researcher	Bi-weekly for three months	Technology, including mobile phones, the internet, and social media platforms, have the power to increase access to care by extending the work of counselors and overcoming geographical barriers. These supports can increase the likelihood of adults quitting compared with no intervention and can be a cost-effective adjunct to other treatments.³⁵

The intervention to be delivered was adapted by collecting data from stakeholders, including health professionals, and interviewing tobacco users from the setting.

Data collection:

After fulfilling the inclusion criteria and seeking written consent, the researcher will collect data from tobacco users enrolled in the study. Baseline and end line (six months) of intervention assessment will include assessment of tobacco use (daily tobacco consumption, age of initiation, quit attempt, treatment sought for cessation (if any)); knowledge, attitude, and practices about tobacco use.

The assessment of motivation to quit tobacco using Readiness to Change questionnaire³⁸ (RCQ); nicotine dependence using FTND scale³⁹: stages of behavior change using a trans-theoretical model of behavior change at each follow-up (0, 1, 3, 6) months. The self-reporting assessment for 7-day point prevalence and continuous tobacco abstinence will also be done at each (0, 1, 3, 6) follow-up month. In addition, a urine sample will be collected at the last follow-up (6 months of intervention) to confirm the cotinine presence biochemically.

Table 2: Data collection items and schedule at baseline & follow up in the study

Study Design and Setting

The study will be a two-armed Randomized Controlled Trial (RCT) conducted in a tertiary care institute of North India.

The tertiary care health center is at the top level of the healthcare delivery system for the public, which provides specialized consultation care, usually on referral from primary and secondary medical care institutes. They include medical colleges and advanced medical research institutes owned and controlled by the central or state government. The study institute is India's premier medical and research institute, with state-of-the-art educational, medical research, and training facilities. It has a bed strength of 1960 across various departments. Four departments viz. Cardiology, Pulmonary Medicine, Neurology, and ENT (Otolaryngology) were purposively selected for the study as we expect maximum enrolment of NCD patients in these departments, which is required to assess the efficacy of the intervention. Apart from the OPD and inpatient services, these departments provide 24 hours emergency services and round-the-clock consultation services.

Study Participants

While there are no generally agreed-upon definitions of heavy tobacco user, intake of 20 cigarettes per day over 10–20 years, corresponding to 10–20 pack-years, has been associated with a clinically relevant increase in morbidity and is used in various studies.^6,7,32 Thus, considering the importance of quantifying tobacco exposure and its correlation to the risk of disease, the criteria of at-least ten pack-years for inclusion of participants, which establishes a baseline smoking or related tobacco products exposure³³, will be used for recruiting the participants visiting tertiary health care setting for study. The participants complying with the eligibility criteria will be informed about the study.

Inclusion, exclusion, and dropout/withdrawal criteria

Participants will be eligible provided they: (1) Are above 18 years of age, (2) Have a history of using tobacco for the last one month and at least ten pack-year or equivalent tobacco, (3) Can read and understand English, Hindi, or Punjabi, (4) Have a mobile phone with text messages/WhatsApp messages accessibility, (5) Are willing to quit and provide written consent for intervention and follow up of 6 months in the study.

Participants will be excluded if they: (1) Are unable to understand any of the languages as mentioned above, (2) Are severely ill to participate in the study and require urgent attention for any of the medical problems, (3) Are already taking treatment for tobacco cessation, and (4) Are mentally ill to accord informed consent for the study.

Participants will be discontinued for the study if they: (1) Voluntarily withdraw the consent, (2) Are not complying with the study schedule, (3) Are not in a condition to continue with the study due to migration or other reasons. The reason for withdrawal will be collected, and no more follow-up will be initiated. Participants who drop out of the study will be considered tobacco users.

Sample Size

Based on existing literature,⁴⁰ where tobacco abstinence rate of 16.8% and 30.3% has been reported in the control and intervention arm, respectively, and considering alpha level 0.05, and 15% dropout rate with the power of 0.80 (0%), a total sample size of 360 is estimated. Participants will be randomly assigned into two arms at a ratio of 1:1 with 180 in each arm. The trial with this sample size will have sufficient power to detect a clinically significant difference between the two arms. The planned sample size will be recruited in approximately three months and followed up for six months.

Assignment of Intervention

Sequence Generation

The participants meeting the inclusion criteria will be randomly assigned by the researcher to either control or intervention arm with a 1:1 allocation as per the randomization sequence generated in advance by a computer program. For ensuring a balanced representation of the participants in two groups from various departments, stratified block randomization with block sizes of four will be used.

Allocation Concealment

To ensure and prevent participants and researcher from knowing the study group to which the next participant will be assigned, concealment of allocation will be maintained using sequentially numbered, opaque sealed envelopes. One of the study members other than the researcher will create the allocation sequence in the opaque envelopes for assigning the intervention group, which the researcher will then open for participants' enrolment.

Implementation

Prior to opening envelopes, the eligibility of participants shall be assessed by the researcher. Eligible participants will then be informed about the trial and asked for their participation. After that, the interested participants will then be enrolled in the intervention arms and provided with the assigned intervention by the study researcher.

Blinding

The study will be single-blinded, where participants assigned to the intervention arm will only be blinded, while the person delivering the intervention and assessing the outcome ( researcher) will be aware of the intervention group to which participants have been assigned.

Intervention:

Intervention/ Treatment Arm

The significant intervention modalities for changing the behavior include face-to-face/individual counseling, telephonic counseling, patient information material in leaflet form, motivational videos, text messages, and the usual care provided in the health center.

The details of the intervention provided in Arm-1 (Brief intervention) and Arm-2 (Intensive intervention) are given in Table 1

Table 1: Behavior change communication intervention in the treatment arms for tobacco users suffering from NCDs in the tertiary care hospital of North India

*INTERVENTION ARM*	*MODE OF DELIVERY*	*PROVIDER*	*TIME DURATION & FREQUENCY*	*BENEFITS*
Brief & Intensive	Individual Counseling	Researcher	10-20 minutes of the session at ^firstcontact	Both minimal (< 20 minutes in 1 visit) and intensive (≥ 20 minutes plus > 1 follow-up visit) physician-advice interventions effectively increase the proportion of adults who successfully quit tobacco and remain abstinent for ≥ 6 months.⁸There is a dose–response relationship between the intensity of counseling and cessation rates (i.e., more or longer sessions improve cessation rates).³⁴
Brief & Intensive	Motivational videos	Researcher	3-5 minutes of video at ^firstcontact	Technology including mobile phones, the internet, and social media platforms, can increase access to care by extending the work of counselors and overcoming the geographical barriers. These supports can increase the likelihood of adults quitting compared with no intervention and can be a cost-effective adjunct to other treatments.³⁵
Brief & Intensive	Patient information leaflet (PIL)	Researcher	1 PIL at ^first contact	Providing self-help materials (primarily print-based) tailored to the individual patient (that is, beyond a brochure that simply describes the health effects of tobacco use and benefits of cessation) is effective in improving tobacco abstinence.³⁶
Intensive	Telephone counseling	Researcher	05-15 minutes of the session, five times at <1,4,6,9,12 week in 3 months after enrolment	Telephone-based access to counseling and smoking cessation resources increases cessation rates. The majority of help-lines provide access to individual counseling; the greatest amount of counselor contact, the greater the likelihood of successful cessation.³⁷
Intensive	Text messages using SMS	Researcher	Bi-weekly for three months	Technology, including mobile phones, the internet, and social media platforms, have the power to increase access to care by extending the work of counselors and overcoming geographical barriers. These supports can increase the likelihood of adults quitting compared with no intervention and can be a cost-effective adjunct to other treatments.³⁵

The intervention to be delivered was adapted by collecting data from stakeholders, including health professionals, and interviewing tobacco users from the setting.

Data collection:

After fulfilling the inclusion criteria and seeking written consent, the researcher will collect data from tobacco users enrolled in the study. Baseline and end line (six months) of intervention assessment will include assessment of tobacco use (daily tobacco consumption, age of initiation, quit attempt, treatment sought for cessation (if any)); knowledge, attitude, and practices about tobacco use.

The assessment of motivation to quit tobacco using Readiness to Change questionnaire³⁸ (RCQ); nicotine dependence using FTND scale³⁹: stages of behavior change using a trans-theoretical model of behavior change at each follow-up (0, 1, 3, 6) months. The self-reporting assessment for 7-day point prevalence and continuous tobacco abstinence will also be done at each (0, 1, 3, 6) follow-up month. In addition, a urine sample will be collected at the last follow-up (6 months of intervention) to confirm the cotinine presence biochemically.

Table 2: Data collection items and schedule at baseline & follow up in the study

* Readiness to change questionnaire, **FTND: Fagerstrom Tobacco Nicotine Dependence, ***7DPPA: 7 days Point Prevalence Abstinence

Outcome Measures:

Primary outcome

Validated 7-day point prevalence tobacco abstinence at six months (last follow-up) measurement using urinary cotinine

Secondary outcomes

Measures at each follow-up period 1, 3, & 6 months:

Self-reported continuous tobacco abstinence
Self-reported 7-day point prevalence tobacco abstinence
Self-reported tobacco use reduction
Readiness to change by RCQ
Scores of Nicotine dependence by FTND instrument
Number of quit attempts and relapses at each follow-up

Measures at follow-up six months

Change in knowledge, attitude, and practices score at six months

Data Analysis:

Data will be analyzed using IBM SPSS version 22. For quantitative data mean, the standard deviation will be estimated, whereas for nominal & ordinal data, median and interquartile range will be calculated, and appropriate statistics will be used. Descriptive statistics will be applied to assess participants' knowledge, attitude, and practice regarding tobacco use. Multivariate logistic analysis will be applied, taking dependent variables as the prevalence of tobacco use and independent variables as age, gender, location, education, and occupation. Pearson correlation test will determine the relationship between knowledge, attitude, and practice towards tobacco use. When comparing the two groups, proportions will assess using the chi-square test and differences between means with paired t-test. To test the inter-rater reliability, kappa statistics will be applied. Any potential confounding variable (e.g., a demographic or tobacco use history variable) that is significantly different across arms despite randomization will be adjusted. The conventional significance level of 0.05 will be used in all analyses to reject the null hypothesis of no difference between groups. Intention to treat analysis will be applied when comparing the outcome in two intervention arms and the participants with unknown tobacco use status will be assumed to being continuous user resulting in conservative estimates of intervention efficacy.

* Readiness to change questionnaire, **FTND: Fagerstrom Tobacco Nicotine Dependence, ***7DPPA: 7 days Point Prevalence Abstinence

Outcome Measures:

Primary outcome

Validated 7-day point prevalence tobacco abstinence at six months (last follow-up) measurement using urinary cotinine

Secondary outcomes

Measures at each follow-up period 1, 3, & 6 months:

Self-reported continuous tobacco abstinence
Self-reported 7-day point prevalence tobacco abstinence
Self-reported tobacco use reduction
Readiness to change by RCQ
Scores of Nicotine dependence by FTND instrument
Number of quit attempts and relapses at each follow-up

Measures at follow-up six months

Change in knowledge, attitude, and practices score at six months

Data Analysis:

Data will be analyzed using IBM SPSS version 22. For quantitative data mean, the standard deviation will be estimated, whereas for nominal & ordinal data, median and interquartile range will be calculated, and appropriate statistics will be used. Descriptive statistics will be applied to assess participants' knowledge, attitude, and practice regarding tobacco use. Multivariate logistic analysis will be applied, taking dependent variables as the prevalence of tobacco use and independent variables as age, gender, location, education, and occupation. Pearson correlation test will determine the relationship between knowledge, attitude, and practice towards tobacco use. When comparing the two groups, proportions will assess using the chi-square test and differences between means with paired t-test. To test the inter-rater reliability, kappa statistics will be applied. Any potential confounding variable (e.g., a demographic or tobacco use history variable) that is significantly different across arms despite randomization will be adjusted. The conventional significance level of 0.05 will be used in all analyses to reject the null hypothesis of no difference between groups. Intention to treat analysis will be applied when comparing the outcome in two intervention arms and the participants with unknown tobacco use status will be assumed to being continuous user resulting in conservative estimates of intervention efficacy.

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.

Trial Status:

Recruitment of participants started in December 2020 and is currently ongoing. The study findings are expected to be available in August 2022.

Ethical Considerationand consent to participate

Permission has been obtained from the Institute Ethical Committee ( No. NK/5415/PhD/140) for the enrollment of participants in the study. Before implementation, any modification in the protocol will be agreed upon and ratified by the Institutional Ethics Committee and Clinical Trial Registry of India (CTRI/2019/09/021406). The researcher will discuss the research purpose, procedure, and rights to the trial to all the participants before enrolment. In addition, informed written consent in preference language (English or regional-Hindi, Punjabi) will be signed by all the participants for voluntary participation. While maintaining confidentiality, information including reports, laboratory results, and other details of the participants shall be stored securely at the study site. At the same time, records shall be kept separately and identified by code number for identification.

Data monitoring /Auditing

A team of experts (Doctoral committee) appointed by the Dean of Institute will regularly supervise the trial's progress. The designated committee members will monitor the safety aspect and recommend trial modifications if required. The annual progress of the research will be submitted to the Institute Ethics Committee (IEC) for approval of safeguarding the rights, safety, and well-being of the trial subjects.

Access to data and material

The dataset analyzed after completion of the study will be available on reasonable request from the corresponding author.

Ancillary and post-trial care

The intervention in the study will be an addition to the usual care provided to the patients visiting the tertiary care center for their illness and, once enrolled, will be followed in the registered departments for post-trial care. While in case of any medical conditions that require more specialized care, a patient will be referred to the concerned department for further treatment.

Competing interests

The author(s) for the review declares to have no competing interests.

Funding

The study has no funding support from the institute for the biochemical verification of the quit status of enrolled tobacco users. The researcher will use a fellowship grant provided by ICMR to pursue the research.

Contribution Information

PD, SG, AA, AG, DK, RV, RV & BM planned and designed the study protocol. All authors contributed substantially to the draft and approved it for submission.

Protocol Amendments:

With the low footfall of patients in the OPD during the COVID pandemic, the study's sample size was revised to 360 from 574, and follow-up was reduced to six months from the 12 months as proposed earlier. It was thoroughly discussed and approved by the Doctoral Committee members in the institute.

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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

Status:

Version 2

Abstract

Figures

Background

Objective:

Methods/design

Study Design and Setting

Study Participants

Inclusion, exclusion, and dropout/withdrawal criteria

Sample Size

Assignment of Intervention

Sequence Generation

Allocation Concealment

Implementation

Blinding

Study Design and Setting

Study Participants

Inclusion, exclusion, and dropout/withdrawal criteria

Sample Size

Assignment of Intervention

Sequence Generation

Allocation Concealment

Implementation

Blinding

Outcome Measures:

Primary outcome

Secondary outcomes

Data Analysis:

Outcome Measures:

Primary outcome

Secondary outcomes

Data Analysis:

Discussion

Declarations

References

Supplementary Files

Status:

Version 2