Clinical Trials Directory

Trials / Completed

CompletedNCT03521466

Medical Student Counseling for Hospitalized Patients Addicted to Tobacco

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
700 (actual)
Sponsor
University Hospitals Cleveland Medical Center · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSmoking 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.

Timeline

Start date
2018-12-12
Primary completion
2020-11-11
Completion
2020-11-11
First posted
2018-05-11
Last updated
2021-10-12

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT03521466. Inclusion in this directory is not an endorsement.