Smoking Cessation CounsellingMS-CHATNCT03521466
Medical Student Counseling for Hospitalized Patients Addicted to Tobacco
A study testing Smoking Cessation Counseling in people with Smoking Cessation Counselling and Medical Student Education, run by University Hospitals Cleveland Medical Center at 1 site in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Smoking Cessation Counselling, Medical Student Education
- What is being tested?
- Smoking Cessation Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteIndia
- Study dates
- 12 Dec 2018to 11 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
PSG Institute of Medical Science and Research
Coimbatore, Tamil Nadu, 641004
About this study
Official title: 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.
Read the 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.
- Being tested
- Smoking Cessation Counseling
- Keywords
- Smoking cessation counselling, Medical Student education, India
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Smoking Cessation counseling by trained medical students with or without Nicotine Replacement Therapy Receives: Behavioral: Smoking Cessation Counseling |
| Control | No intervention | The control group will receive counseling and/or NRT at the discretion of the treating physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months from enrolment
Secondary outcomes (9)
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)
Measured: 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
Measured: 2 and 6 months from enrolment
Correlation between verified quit rates at 6 months and FTND scores at enrolment
Measured: 6 months from enrolment
Number of patients who report having quit smoking in the last 7 days (irrespective of biochemical verification)
Measured: 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
Measured: 6 months from enrolment
No of patients who have refrained from using smokeless tobacco in the last 7 days, measured at 6 months.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start12 Dec 2018
- Primary completion11 Nov 2020
- Study completion11 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking Cessation CounsellingStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Government Calicut Medical College, Wayanad Institute of Medical Sciences, PSG Institute of Medical Science and Research
- Responsible party
- Principal investigator, Richard Josephson, MS MD, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521466
- Sponsor's protocol ID
- 01-18-11
- Acronym
- MS-CHAT
- Status last verified
- Oct 2021
- First submitted
- 14 Apr 2018
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Satish P, Khetan A, Shah D, Srinivasan S, Balakrishnan R, Padmanandan A, Hejjaji V, Hull L, Samuel R, Josephson R. Effectiveness of Medical Student Counseling for Hospitalized Patients Addicted to Tobacco (MS-CHAT): a Randomized Controlled Trial. J Gen Intern Med. 2023 Nov;38(14):3162-3170. doi: 10.1007/s11606-023-08243-y. Epub 2023 Jun 7.
PubMed 37286774
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial Evaluating the Effectiveness of a Medical Student Guided Smoking Cessation Program for Hospitalized Smokers in India
- ClinicalTrials.gov ID
- NCT03521466
- Acronym / sponsor ID
- MS-CHAT / 01-18-11
- Keywords
- Smoking cessation counselling, Medical Student education, India
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Government Calicut Medical College, Wayanad Institute of Medical Sciences, PSG Institute of Medical Science and Research
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Smoking Cessation CounselingSmoking Cessation counseling by trained medical students with or without Nicotine Replacement Therapy |
| Control | No intervention | –The control group will receive counseling and/or NRT at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking Cessation CounselingTrained 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. | Behavioural | Intervention |
Primary outcome
Biochemically verified 7 day quit rate measured 6 months after enrolment.
Time frame: 6 months from 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).
9 secondary outcomes
Biochemically verified 90 day quit rate, measured 6 months after enrolment
Time frame: 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
Time frame: 2 and 6 months from enrolment
Correlation between verified quit rates at 6 months and FTND scores at enrolment
Time frame: 6 months from enrolment
Number of patients who report having quit smoking in the last 7 days (irrespective of biochemical verification)
Time frame: 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
Time frame: 6 months from enrolment
No of patients who have refrained from using smokeless tobacco in the last 7 days, measured at 6 months.
Time frame: 6 months from enrolment
Pre-post analysis of medical student knowledge about counseling techniques and pharmacotherapy
Time frame: 6 weeks and 12 months after training
Qualitative analysis of student attitudes towards smoking cessation counseling
Time frame: 12 months after training
Qualitative analysis of the feasibility and acceptability of the intervention
Time frame: 12 months after training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Derived from this study: PubMed 37286774Satish P, Khetan A, Shah D, Srinivasan S, Balakrishnan R, Padmanandan A, Hejjaji V, Hull L, Samuel R, Josephson R. Effectiveness of Medical Student Counseling for Hospitalized Patients Addicted to Tobacco (MS-CHAT): a Randomized Controlled Trial. J Gen Intern Med. 2023 Nov;38(14):3162-3170. doi: 10.1007/s11606-023-08243-y. Epub 2023 Jun 7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Cessation Counseling in people with Smoking Cessation Counselling and Medical Student Education, run by University Hospitals Cleveland Medical Center at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically verified 7 day quit rate measured 6 months after enrolment. (time frame: 6 months from enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03521466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.