Medical Student Counseling for Hospitalized Patients Addicted to Tobacco (MS-CHAT)

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation Counselling; Medical Student Education
• Intervention / Treatment: Behavioral: Smoking Cessation Counseling

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Tamil Nadu
    • Coimbatore, Tamil Nadu, India, 641004
      • PSG Institute of Medical Science and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients age 18-70 years old, who are admitted to the medical, and if required surgical wards.
2. 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).
3. Patients living within 10 Km radius of the hospital.

Exclusion Criteria:

1. Unwilling to participate
2. Patients who use only non-smoked tobacco will be excluded.
3. Patients who are are daily alcohol users, daily cannabis or psychotropic drug users.
4. Patients who do not have a telephone/ unable to follow up
5. Patients unable to understand the local/common language
6. Patients with psychiatric conditions rendering them incapable of interacting with the providers
7. Medically unstable patients
8. Patients with expected hospital stay <24 hours
9. Patients with life expectancy < 12 months
10. Pregnant patients
11. Patients currently participating in a tobacco cessation program
12. Prior participation in this trial during another hospitalisation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Smoking Cessation counseling by trained medical students with or without Nicotine Replacement Therapy	Behavioral: Smoking Cessation Counseling; 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.
No Intervention: Control; The control group will receive counseling and/or NRT at the discretion of the treating physician.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of eligible patients that receive inpatient counseling and atleast 3 follow up calls	Data from the patient screening and follow up forms will be used to calculate this ratio	2 months from enrolment
Number of patients who use any form of cessation pharmacotherapy within the first 2 months	Patients will be asked to report the use of pharmacotherapy during their 2 month follow up call	2 months from enrolment
Number of patients enrolled in the study that are available for follow up at 6 months		6 months from enrolment

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: PSG Institute of Medical Science and Research; Government Calicut Medical College; Wayanad Institute of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2018
• Primary Completion (Actual): November 11, 2020
• Study Completion (Actual): November 11, 2020

Study Registration Dates

• First Submitted: April 14, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: India; Smoking cessation counselling; Medical Student education
• Other Study ID Numbers: 01-18-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No