Helping Hospitalized Patients Quit Smoking

January 8, 2016 updated by: David Warner, Mayo Clinic

The study is being done to determine whether an in-hospital intervention using a brief intervention to facilitate quitline utilization will increase quitline utilization by hospitalized smokers, and will increase post hospital discharge smoking abstinence rates.

Study participants will be randomized to receive either a brief quitline facilitation intervention , or a control intervention of a brief stop-smoking message.

The study will also compare healthcare costs and utilization in the first six months following hospitalization between the two groups.

Study Overview

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 4

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

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

Current smoker, Resident of Olmsted County, Inpatient admission to St. Marys or Rochester Methodist Hospital, Able to participate fully in all study aspects, Available for follow-up

Exclusion Criteria:

Current active treatment for tobacco use initiated prior to hospitalization

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Quitline facilitation intervention
brief quitline facilitation intervention given
brief quitline facilitation intervention
ACTIVE_COMPARATOR: Stop-smoking intervention
brief review of tips to maintain smoking abstinence, using brochure
brief review of tips to help maintain smoking abstinence, using brochure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
7-day point prevalence tobacco abstinence at 6 months after hospitalization
Time Frame: 6 months after hospitalization
6 months after hospitalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-efficacy
Time Frame: Immediately after the delivery of the brief intervention (day of enrollment)
Use of Smoking Self-Efficacy Questionnaire 12
Immediately after the delivery of the brief intervention (day of enrollment)

Collaborators and Investigators

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

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

May 1, 2012

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

April 9, 2012

First Submitted That Met QC Criteria

April 9, 2012

First Posted (ESTIMATE)

April 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2016

Last Update Submitted That Met QC Criteria

January 8, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 12-002207

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.

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