Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-30 @ 6:08 AM
Study NCT ID:
NCT03521466
Status:
COMPLETED
Last Update Posted:
2021-10-12
First Post:
2018-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical Student Counseling for Hospitalized Patients Addicted to Tobacco
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
Study Overview
Official Title:
A Randomized Control Trial Evaluating the Effectiveness of a Medical Student Guided Smoking Cessation Program for Hospitalized Smokers in India
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MS-CHAT
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: