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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03521466
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : July 30, 2019
Sponsor:
Collaborators:
Government Calicut Medical College
Wayanad Institute of Medical Sciences
PSG Institute of Medical Science and Research
Information provided by (Responsible Party):
Richard Josephson, MS MD, University Hospitals Cleveland Medical Center

Brief 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 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.


Condition or disease Intervention/treatment Phase
Smoking Cessation Counselling Medical Student Education Behavioral: Smoking Cessation Counseling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 864 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Coordinators calling the patient to assess quit status are blinded to group assignment.
Primary Purpose: Prevention
Official Title: A Randomized Control Trial Evaluating the Effectiveness of a Medical Student Guided Smoking Cessation Program for Hospitalized Smokers in India
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Biochemically verified 90 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 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)

  2. 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 ]
  3. Correlation between verified quit rates at 6 months and FTND scores at enrolment [ Time Frame: 6 months from enrolment ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. Pre-post analysis of medical student knowledge about counseling techniques and pharmacotherapy [ Time Frame: 6 weeks and 12 months after training ]
    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.

  8. Qualitative analysis of student attitudes towards smoking cessation counseling [ Time Frame: 12 months after training ]
    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.

  9. Qualitative analysis of the feasibility and acceptability of the intervention [ Time Frame: 12 months after training ]
    Students who participate in the trial will receive a survey with open ended questions. The responses will be analysed to identify relevant themes.


Other Outcome Measures:
  1. Number of eligible patients that receive inpatient counseling and atleast 3 follow up calls [ Time Frame: 2 months from enrolment ]
    Data from the patient screening and follow up forms will be used to calculate this ratio

  2. Number of patients who use any form of cessation pharmacotherapy within the first 2 months [ Time Frame: 2 months from enrolment ]
    Patients will be asked to report the use of pharmacotherapy during their 2 month follow up call

  3. Number of patients enrolled in the study that are available for follow up at 6 months [ Time Frame: 6 months from enrolment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521466


Contacts
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Contact: Priyanka Satish 216-844-1000 priyanka.satish2@uhhospitals.org

Locations
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India
PSG Institute of Medical Science and Research Recruiting
Coimbatore, Tamil Nadu, India, 641004
Contact: Subhashini Ganesan    +918754479744    drsubhiganesan@gmail.com   
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Government Calicut Medical College
Wayanad Institute of Medical Sciences
PSG Institute of Medical Science and Research

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Responsible Party: Richard Josephson, MS MD, Director CVP Rehabilitation, Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT03521466     History of Changes
Other Study ID Numbers: 01-18-11
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Josephson, MS MD, University Hospitals Cleveland Medical Center:
Smoking cessation counselling
Medical Student education
India