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

Sponsor

Medical University of South Carolina (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04827914

Collaborator

(none)

1,122

Enrollment

Locations

Arms

16.8

Anticipated Duration (Months)

187

Patients Per Site

11.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Behavioral: Enhanced Care Behavioral: Basic Care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 8, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Self-reported smoking prevalence 6-weeks after hospitalization. [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%)
Self-reported use of FDA Approved Smoking Cessation Medication [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%)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Psychiatry	Charleston	South Carolina	United States	29425
2	MUSC	Charleston	South Carolina	United States	29425
3	MUSC	Chester	South Carolina	United States	29706
4	MUSC	Florence	South Carolina	United States	29505
5	MUSC	Lancaster	South Carolina	United States	29720
6	MUSC	Marion	South Carolina	United States	29574

Sponsors and Collaborators

Medical University of South Carolina

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kenneth M Cummings, PhD, Professor, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT04827914

Other Study ID Numbers:

107000

First Posted:

Apr 1, 2021

Last Update Posted:

Apr 22, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Apr 22, 2022