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

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ClinicalTrials.gov Identifier: NCT01277250
Recruitment Status : Completed
First Posted : January 14, 2011
Last Update Posted : June 19, 2015
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Alabama at Birmingham

January 12, 2011
January 14, 2011
June 19, 2015
July 2011
September 2014   (Final data collection date for primary outcome measure)
Smoking abstinence [ Time Frame: 6 months ]
Biochemically-verified (cotinine) and self-reported tobacco abstinence
Same as current
Complete list of historical versions of study NCT01277250 on ClinicalTrials.gov Archive Site
Smoking abstinence [ Time Frame: 3 and 12 months ]
self-reported tobacco abstinence
Same as current
Not Provided
Not Provided
 
Web-based Smoking Cessation Intervention: Transition From Inpatient to Outpatient
Web-based Smoking Cessation Intervention: Transition From Inpatient to Outpatient
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Cigarette Smoking
  • Home Access to Internet and Email
  • Cognitively and Physically Able to Participate
  • English Speaking and Reading
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
  • Usual Care
    Standard smoking cessation information provided to all hospitalized patients as part of discharge packet.
    Intervention: Behavioral: Web-based smoking cessation program
  • 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.
    Intervention: Behavioral: Web-based smoking cessation program

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1548
1488
November 2014
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01277250
1U01DA031515( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of Alabama at Birmingham
University of Alabama at Birmingham
National Institute on Drug Abuse (NIDA)
Principal Investigator: Kathleen F Harrington, PhD, MPH The University of Alabama at Birmingham
University of Alabama at Birmingham
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP