Clinical trial NCT03521466: Medical Student Counseling for Hospitalized Patients Addicted to Tobacco
Official title: A Randomized Control Trial Evaluating the Effectiveness of a Medical Student Guided Smoking Cessation Program for Hospitalized Smokers in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation Counselling
Medical Student Education
Keywords: Smoking cessation counselling
Medical Student education
India
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Government Calicut Medical College
name: Wayanad Institute of Medical Sciences
name: PSG Institute of Medical Science and Research
First posted: 2018-05-11
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Biochemically verified 7 day quit rate measured 6 months after enrolment.
timeFrame: 6 months from enrolment
Secondary outcomes:
measure: Biochemically verified 90 day quit rate, measured 6 months after enrolment
timeFrame: 6 months from enrolment
measure: 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
timeFrame: 2 and 6 months from enrolment
measure: Correlation between verified quit rates at 6 months and FTND scores at enrolment
timeFrame: 6 months from enrolment
measure: Number of patients who report having quit smoking in the last 7 days (irrespective of biochemical verification)
timeFrame: 2 and 6 months from enrolment
measure: Agreement between self reported quit 7 day quit rate and biochemically verified 7 day quit rate, measured at 6 months from enrolment
timeFrame: 6 months from enrolment
measure: No of patients who have refrained from using smokeless tobacco in the last 7 days, measured at 6 months.
timeFrame: 6 months from enrolment
measure: Pre-post analysis of medical student knowledge about counseling techniques and pharmacotherapy
timeFrame: 6 weeks and 12 months after training
measure: Qualitative analysis of student attitudes towards smoking cessation counseling
timeFrame: 12 months after training
measure: Qualitative analysis of the feasibility and acceptability of the intervention
timeFrame: 12 months after training
Other outcomes:
measure: Number of eligible patients that receive inpatient counseling and atleast 3 follow up calls
timeFrame: 2 months from enrolment
measure: Number of patients who use any form of cessation pharmacotherapy within the first 2 months
timeFrame: 2 months from enrolment
measure: Number of patients enrolled in the study that are available for follow up at 6 months
timeFrame: 6 months from enrolment
Locations:
city: Coimbatore
country: India
facility: PSG Institute of Medical Science and Research
state: Tamil Nadu
Study officials:
References: