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

NCT04827914 | Active Not Recruiting

• 1 other identifier: 107000
• Study Type: interventional
• Target: 1,122
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Enhanced Care Condition

EXPERIMENTAL

Behavioral: Enhanced Care

Basic Care Condition

ACTIVE COMPARATOR

Behavioral: Basic Care

Interventions

Enhanced Care BEHAVIORAL

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.

Enhanced Care Condition

Basic Care BEHAVIORAL

Smokers assigned to the basic care group will only receive the post-discharge IVR phone calls.

Basic Care Condition

Eligibility Criteria

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

You may qualify if:

• + years and older
• hospitalized cigarette smokers eligible for either enhanced or basic care
• discharged from the hospital back to their home

You may not qualify if:

• patients without a phone number
• those unable to communicate in the English language

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (6)

Institute of Psychiatry

Charleston, South Carolina, 29425, United States

Location

MUSC

Charleston, South Carolina, 29425, United States

Location

MUSC

Chester, South Carolina, 29706, United States

Location

MUSC

Florence, South Carolina, 29505, United States

Location

MUSC

Lancaster, South Carolina, 29720, United States

Location

MUSC

Marion, South Carolina, 29574, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Kenneth M Cummings, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: March 8, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

US (6)