Web-based Smoking Cessation Intervention: Transition From Inpatient to Outpatient

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT01277250
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
1,548
1
2
40
38.7

Study Details

Study Description

Brief Summary

This project, "Web-based Smoking Cessation Intervention: transition from inpatient to outpatient," addresses smoking among hospitalized patients, whose rates are higher than among the general population. Hospitalization offers a unique opportunity to intervene, as it requires temporary abstinence and patients are focused on health concerns. Hypotheses: A tailored web-based and e-message smoking cessation program for current smokers that, upon hospital discharge, transitions the patient to continue a quit attempt when home will be effective. Further, the investigators hypothesize that this approach will be cost-effective. Specific Aims: 1. To test the effectiveness of a web-based smoking cessation intervention. 2. To determine the cost-effectiveness of this approach. Research Design - Methods: A randomized two-arm follow-up design will be used to test the effectiveness of an evidence- and theoretically-based smoking cessation program designed for post-hospitalization. Patients randomized to this arm will be contacted by hospital staff, trained as 'transition coaches,' to engage in Decide2Quit, an interactive web-based program that offers personalized and tailored messages, e-group support, and text messages promoting tobacco abstinence. All hospitalized patients will receive standardized smoking cessation materials. As well, physicians can order nicotine replacement therapy via the hospital's electronic order system. The investigators primary outcome is biologically confirmed and self-reported tobacco abstinence at 6 months follow-up; the investigators will also assess self-reported quit rates at 3 and 12 months and variables hypothesized to predict quit success. We will measure health care utilization and quality of life to allow testing the cost-effectiveness of this program conducted from the perspective of a hospital, health care payers, patients and society. Significance of results: At study completion the investigators will know whether imbedding smoking cessation into usual hospital care, with minimal hospital-staff burden, and an interactive web-based tailored intervention program is an effective way to reduce smoking rates among hospitalized patients, and if it is cost-effective. This program will be an "off the shelf approach that could be disseminated easily.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Web-based smoking cessation program
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
1548 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Web-based Smoking Cessation Intervention: Transition From Inpatient to Outpatient
Study Start Date :
Jul 1, 2011
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: Usual Care

Standard smoking cessation information provided to all hospitalized patients as part of discharge packet.

Behavioral: Web-based smoking cessation program
Web-based smoking cessation program that includes a "transition coach" to hospitalized patients who will assist them in quitting as they are discharged from the hospital. Intervention arm participants will have access to a tailored web-based intervention that will include e-messages and activities that are tailored to their recent hospital stay.
Other Names:
  • Tobacco Treatment
  • Behavioral Counseling
  • Computer-Assisted Treatment
  • Experimental: Smoking Cessation Program

    Web-based program tailored to patients who smoke and are hospitalized. Program is tailored to participant's specific hospital experience and other characteristics. E-messages, social support and a "transition coach" are provided to each participant in this condition.

    Behavioral: Web-based smoking cessation program
    Web-based smoking cessation program that includes a "transition coach" to hospitalized patients who will assist them in quitting as they are discharged from the hospital. Intervention arm participants will have access to a tailored web-based intervention that will include e-messages and activities that are tailored to their recent hospital stay.
    Other Names:
  • Tobacco Treatment
  • Behavioral Counseling
  • Computer-Assisted Treatment
  • Outcome Measures

    Primary Outcome Measures

    1. Smoking abstinence [6 months]

      Biochemically-verified (cotinine) and self-reported tobacco abstinence

    Secondary Outcome Measures

    1. Smoking abstinence [3 and 12 months]

      self-reported tobacco abstinence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 19 years of age or older

    • Current smoker (at least one puff in the last 30 days)

    • Regular (at least weekly) email/internet access

    • Can read and speak English

    • Can communicate well enough to provide meaningful responses to the screening questions and informed consent

    • Well enough to participate (provide meaningful responses to the screening questions and informed consent)

    • On standard or contact isolation only

    • Cognitively able to participate (to provide meaningful responses to the screening questions and informed consent)

    • Does not have another household member participating in this study

    Exclusion Criteria:
    • Under age 19

    • Non-smoker

    • Cannot read and speak English

    • No email/internet access

    • Cannot communicate well enough to provide meaningful responses to the screening questions and informed consent

    • Too ill to participate (provide meaningful responses to the screening questions and informed consent)

    • On isolation precautions other than standard or contact

    • Cognitively unable to participate (to provide meaningful responses to the screening questions and informed consent)

    • Has another household member participating in this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Alabama at Birmingham - Lung Health Center Birmingham Alabama United States 35294

    Sponsors and Collaborators

    • University of Alabama at Birmingham
    • National Institute on Drug Abuse (NIDA)

    Investigators

    • Principal Investigator: Kathleen F Harrington, PhD, MPH, The University of Alabama at Birmingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT01277250
    Other Study ID Numbers:
    • 1U01DA031515
    First Posted:
    Jan 14, 2011
    Last Update Posted:
    Jun 19, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by University of Alabama at Birmingham

    Study Results

    No Results Posted as of Jun 19, 2015