A randomised control trial evaluating the effectiveness of a medical student guided tobacco cessation program for hospitalised smokers in India.

Not yet recruiting

Conditions: Hospitalised patients who smoke tobacco

Registration Number: CTRI/2018/04/013514

Lead Sponsor: SEHAT India

Brief Summary: The adverse outcomes associated with tobacco use are well documented and include an increased risk of cardiovascular diseases, cancers, respiratory diseases, adverse effects in pregnancy and oral diseases. One-half of all smokers will die prematurely as a consequence of their tobacco use. Tobacco cessation substantially reduces the risk of death associated with smoking and interventions to quit smoking are both efficacious and cost-effective. Every hospitalisation provides an opportunity to perform these interventions. Counselling for smoking cessation needs to be started during the hospitalisation and should be continued for at least a month after discharge to be effective. To address the twin problems of inadequate medical student training and lack of systematic counselling of hospitalized smokers, we designed a study to implement a smoking cessation training module for medical students, which will include a component of practical training amongst hospitalized smokers. We hypothesise that this training module will simultaneously result in improved quit rates amongst hospitalized smokers and improve medical student knowledge and comfort with counselling.

**MEDICAL STUDENT TRAINING:**

Students at each site will sit through a workshop conducted by a psychiatrist educator. There will be a didactic lecture, followed bygroup role-playing scenarios for 1â€“2 hours (students split into pairs and enactdifferent scenarios), with peer and proctor feedback. Students who complete the workshop and test out using a questionnaire will be inducted into the trial.

**PATIENT COUNSELLING:**

Asite coordinator will be recruited separately and trained. He/she will approachall patients in medicine, cardiology and/or pulmonology wards, who are eligiblefor the study. Consented patients will be stratified based on the centre and randomly assigned tointervention and control arms. Participating medical students willoffer inpatient counselling to patients in the intervention arm once duringtheir hospitalisation (recommended duration of 15-20 minutes).

**Pharmacotherapy:**

Medical students are allowed to decide if their patients are eligible forNicotine Replacement Therapy (nicotine gum and/or patch). These products can bepurchased from the local pharmacy upon discharge after approval by theattending physician/resident involved in the patientâ€™s care. Patients will beadvised not to use the gum or patch until after the quit date.

**Follow up:**

Students will then follow up with their patients and provide telephonecounselling (a minimum of 3 sessions of 15 mins each over 2 months). At eachsession, the student will assess the patientâ€™s motivation and discuss relevantthemes. He/she will also maintain patient information in a workbook.

The control patients will not receive specialised counselling. For thesepatients, smoking cessation advice and referring to counselling are left at thediscretion of the treating physician. The number of patients counselled bytheir treating physician will be tracked throughout the study.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 864

Inclusion Criteria

Patients age 18-70 years old, who are admitted to the medical, cardiology and /or pulmonology 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 2.
Patients who use any form of non-smoked tobacco will be excluded.
If the required sample size is not met because of this exclusion criteria, smokers who concurrently chew tobacco will be included.
Patients who are concurrently alcohol dependent, current cannabis or psychotropic drug users as per ICD 10.
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 & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients will be asked to report abstinence from smoking over the past 7 days; this will be confirmed by exhaled carbon monoxide breath testing.	6 months from enrollment

Secondary Outcome Measures

Name	Time	Method
Medical student knowledge before and 6 weeks after the training workshop.

Trial Locations

Locations (3): Kempegowda Institue of Medical Sciences
🇮🇳
Bangalore, KARNATAKA, India
Paramukhswami Medical Colege
🇮🇳
Anand, GUJARAT, India
PSG Institute of Medical Sciences and Research
🇮🇳
Coimbatore, TAMIL NADU, India
Kempegowda Institue of Medical Sciences
🇮🇳Bangalore, KARNATAKA, India
Dr Anwith HS
Principal investigator
9844467237
anwith2006@gmail.com