Evaluation of an "Opt-Out" Inpatient Smoking Cessation Service on Smoking Behavior Study #1

Smoking Cessation Clinical Trial

Official title:

Dissemination of an Inpatient Smoking Cessation Program to South Carolina Hospitals Study #1

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04827914
• Other study ID #: 107000
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The modest goal of this study is to replicate the behavioral outcomes of the opt out MUSC-Tobacco Treatment Program in the following three patient groups: 1) psychiatric inpatients housed in the Institute of Psychiatry (IOP) in Charleston; 2) non-IOP patients seen in Charleston; and 3) patients seen in the other four MUSC affiliated hospitals combined (i.e., Chester, Florence, Lancaster, and Marion). The aims and the design/methods utilized for evaluation will be the same for each of the three patient groups.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1122
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18+ years and older

• hospitalized cigarette smokers eligible for either enhanced or basic care

• discharged from the hospital back to their home

Exclusion Criteria:

• patients without a phone number

• those unable to communicate in the English language

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Enhanced Care
Smokers in the enhanced care group will receive live counseling (either in person or telehealth consult) while hospitalized combined with post-hospital discharge automated calls using interactive voice recognition (IVR) technology.
• Basic Care
Smokers assigned to the basic care group will only receive the post-discharge IVR phone calls.

Locations

Country	Name	City	State
United States	Institute of Psychiatry	Charleston	South Carolina
United States	MUSC	Charleston	South Carolina
United States	MUSC	Chester	South Carolina
United States	MUSC	Florence	South Carolina
United States	MUSC	Lancaster	South Carolina
United States	MUSC	Marion	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported smoking prevalence 6-weeks after hospitalization.	Hypothesize that patients exposed to the enhanced care intervention compared to basic care will report a 2-fold higher 7-day non-smoker prevalence rate after hospitalization (i.e., 20% vs 10%)	Assessed 6-weeks post-discharge
Primary	Self-reported use of FDA Approved Smoking Cessation Medication	Hypothesize that patients exposed to the enhanced care intervention compared to basic care will report a 2.5-fold greater use of an FDA approved stop smoking medication after hospitalization (i.e., 20% vs 8%)	Assessed 6-weeks post-discharge