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

January 3, 2024 updated by: Kenneth M Cummings, PhD, Medical University of South Carolina

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC
      • Charleston, South Carolina, United States, 29425
        • Institute of Psychiatry
      • Chester, South Carolina, United States, 29706
        • MUSC
      • Florence, South Carolina, United States, 29505
        • MUSC
      • Lancaster, South Carolina, United States, 29720
        • MUSC
      • Marion, South Carolina, United States, 29574
        • MUSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced Care Condition
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.
Active Comparator: Basic Care Condition
Behavioral: Basic Care
Smokers assigned to the basic care group will only receive the post-discharge IVR phone calls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported smoking prevalence 6-weeks after hospitalization.
Time Frame: Assessed 6-weeks post-discharge
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
Time Frame: Assessed 6-weeks post-discharge
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Kenneth M Cummings, PhD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2021

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

March 30, 2021

First Submitted That Met QC Criteria

March 30, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 107000

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking Cessation

Clinical Trials on Enhanced Care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe