Medical Student Counseling for Hospitalized Patients Addicted to Tobacco

Study Overview
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Brief Summary
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The purpose of this randomized control trial is two- fold. The primary hypothesis of the study is that smoking cessation counseling delivered through trained medical students will lead to higher rates of abstinence amongst patients in the intervention group, as compared to a control group, when measured by self-reported and biochemical testing at 6 months after enrolment . The secondary hypothesis is that medical students engaging in a structured curriculum that includes counseling hospitalized smokers will show demonstrable increases in knowledge, confidence in their abilities, and use of smoking cessation techniques in regular practice.

Detailed Description
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India is the 2nd largest consumer of tobacco in the world, with 275 million Indians using tobacco. Each hospitalization is an opportunity for providers to motivate their patients to quit. However, the Indian medical curriculum typically offers little training in the skills required to successfully counsel a patient to quit smoking. The investigators hypothesize that trained medical students can increase subsequent quit rates among hospitalized smokers, while acquiring skills in tobacco cessation counseling. The investigators propose a 2-armed multicenter randomized controlled trial (RCT) that will compare the effectiveness of standard hospital practice versus a medical student-guided smoking cessation program initiated inpatient and continued for three months after discharge. The target study population includes current smokers admitted to the general medicine, pulmonary and cardiology wards. These patients will be randomized to receive either usual care or the intervention. The intervention group will receive both inpatient and longitudinal post-discharge telephone counseling by medical students who have successfully completed a training workshop in tobacco cessation counseling and pharmacotherapy. The students can also recommend nicotine replacement therapy (NRT) to the patient if indicated. The control group will receive counseling and/or NRT at the discretion of the treating physician. They will not receive phone based counseling after discharge. Patients from both groups will be asked to report their quit status 6 months after enrolment.

Official Title
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A Randomized Control Trial Evaluating the Effectiveness of a Medical Student Guided Smoking Cessation Program for Hospitalized Smokers in India

Conditions
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Smoking Cessation Counselling, Medical Student Education

Intervention / Treatment
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* Behavioral: Smoking Cessation Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age 18-70 years old, who are admitted to the medical, and if required surgical wards. Patients must be current smokers (cigarettes and/or bidis) at the time of admission or report having smoked at all in the last 4 weeks prior to admission (to account for changes in behaviour during illness). Patients living within 10 Km radius of the hospital. Exclusion Criteria: Unwilling to participate Patients who use only non-smoked tobacco will be excluded. Patients who are are daily alcohol users, daily cannabis or psychotropic drug users. Patients who do not have a telephone/ unable to follow up Patients unable to understand the local/common language Patients with psychiatric conditions rendering them incapable of interacting with the providers Medically unstable patients Patients with expected hospital stay <24 hours Patients with life expectancy < 12 months Pregnant patients Patients currently participating in a tobacco cessation program Prior participation in this trial during another hospitalisation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Smoking Cessation counseling by trained medical students with or without Nicotine Replacement Therapy | Behavioral: Smoking Cessation Counseling<br>* Trained medical students will visit patients inpatient while hospitalized and provide smoking cessation counseling and recommend Nicotine Replacement Therapy. They will continue to follow these patients for 2 months after discharge and provide telephone-based counseling.<br>|
| No Intervention: Control<br>The control group will receive counseling and/or NRT at the discretion of the treating physician. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically verified 7 day quit rate measured 6 months after enrolment. | At 6 months from enrolment, patients will be asked to report abstinence from smoking over the last 7 days (No more than 5 cigarettes in total since quit date); those who claim to have quit will be asked to provide biochemical confirmation by exhaled carbon monoxide breath testing (<10 Parts Per Million will be considered a verified quit attempt). | 6 months from enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically verified 90 day quit rate, measured 6 months after enrolment | At 6 months from enrolment, patients will be asked to report abstinence from smoking over the last 90 days; those who claim to have quit will be asked to provide confirmation by exhaled carbon monoxide breath testing (<10 Parts Per Million will be considered a verified quit attempt) | 6 months from enrolment | 
| Number of patients achieving a 50% reduction in the number of cigarettes /bidis smoked in a week, measured at 2 and 6 months after enrolment |  | 2 and 6 months from enrolment | 
| Correlation between verified quit rates at 6 months and FTND scores at enrolment |  | 6 months from enrolment | 
| Number of patients who report having quit smoking in the last 7 days (irrespective of biochemical verification) |  | 2 and 6 months from enrolment | 
| Agreement between self reported quit 7 day quit rate and biochemically verified 7 day quit rate, measured at 6 months from enrolment |  | 6 months from enrolment | 
| No of patients who have refrained from using smokeless tobacco in the last 7 days, measured at 6 months. |  | 6 months from enrolment | 
| Pre-post analysis of medical student knowledge about counseling techniques and pharmacotherapy | Students will be given a knowledge questionnaire before training and 6 weeks after training. The questionnaire will be scored from 0 to 22, 0 being the lowest and 22 being the highest score. | 6 weeks and 12 months after training | 
| Qualitative analysis of student attitudes towards smoking cessation counseling | Assessed by surveying students who participated in counseling patients. Some questions will be scored on a Likert scale ranging from 1-5; Others are open ended questions and will be analyzed to identify relevant themes. | 12 months after training | 
| Qualitative analysis of the feasibility and acceptability of the intervention | Students who participate in the trial will receive a survey with open ended questions. The responses will be analysed to identify relevant themes. | 12 months after training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation counselling, Medical Student education, India