Medical Student Counseling for Hospitalized Patients Addicted to Tobacco

NCT03521466 | Completed

• 1 other identifier: 01-18-11
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation Counselling; Medical Student Education

Keywords

Smoking cessation counselling; Medical Student education; India

Outcome Measures

Primary Outcomes (1)

• Biochemically verified 7 day quit rate measured 6 months after 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).

  6 months from enrolment

Secondary Outcomes (9)

• Biochemically verified 90 day quit rate, measured 6 months after enrolment

  6 months from enrolment

• 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

  2 and 6 months from enrolment

• Correlation between verified quit rates at 6 months and FTND scores at enrolment

  6 months from enrolment

• Number of patients who report having quit smoking in the last 7 days (irrespective of biochemical verification)

  2 and 6 months from enrolment

• Agreement between self reported quit 7 day quit rate and biochemically verified 7 day quit rate, measured at 6 months from enrolment

  6 months from enrolment

Other Outcomes (3)

• Number of eligible patients that receive inpatient counseling and atleast 3 follow up calls

  2 months from enrolment

• Number of patients who use any form of cessation pharmacotherapy within the first 2 months

  2 months from enrolment

• Number of patients enrolled in the study that are available for follow up at 6 months

  6 months from enrolment

Study Arms (2)

Intervention

EXPERIMENTAL

Smoking Cessation counseling by trained medical students with or without Nicotine Replacement Therapy

Behavioral: Smoking Cessation Counseling

Control

NO INTERVENTION

The control group will receive counseling and/or NRT at the discretion of the treating physician.

Interventions

Smoking Cessation Counseling BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18-70 years old, who are admitted to the medical, and if required surgical 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.

You may not qualify if:

• Unwilling to participate
• Patients who use only non-smoked tobacco will be excluded.
• Patients who are are daily alcohol users, daily cannabis or psychotropic drug users.
• Patients who do not have a telephone/ unable to follow up
• Patients unable to understand the local/common language
• Patients with psychiatric conditions rendering them incapable of interacting with the providers
• Medically unstable patients
• Patients with expected hospital stay \<24 hours
• Patients with life expectancy \< 12 months
• Pregnant patients
• Patients currently participating in a tobacco cessation program
• Prior participation in this trial during another hospitalisation

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Government Calicut Medical College: collaborator
• Wayanad Institute of Medical Sciences: collaborator
• PSG Institute of Medical Science and Research: collaborator

Study Sites (1)

PSG Institute of Medical Science and Research

Coimbatore, Tamil Nadu, 641004, India

Location

Related Publications (1)

• Satish P, Khetan A, Shah D, Srinivasan S, Balakrishnan R, Padmanandan A, Hejjaji V, Hull L, Samuel R, Josephson R. Effectiveness of Medical Student Counseling for Hospitalized Patients Addicted to Tobacco (MS-CHAT): a Randomized Controlled Trial. J Gen Intern Med. 2023 Nov;38(14):3162-3170. doi: 10.1007/s11606-023-08243-y. Epub 2023 Jun 7.

  PMID: 37286774 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Coordinators calling the patient to assess quit status are blinded to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director CVP Rehabilitation, Harrington Heart and Vascular Institute

Study Record Dates

• First Submitted: April 14, 2018
• First Posted: May 11, 2018
• Study Start: December 12, 2018
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2020
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

IN (1)