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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kathy Harrington, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01277250
First received: January 12, 2011
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Cigarette Smoking
Home Access to Internet and Email
Cognitively and Physically Able to Participate
English Speaking and Reading
Behavioral: Web-based smoking cessation program
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Web-based Smoking Cessation Intervention: Transition From Inpatient to Outpatient

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Smoking abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Biochemically-verified (cotinine) and self-reported tobacco abstinence


Secondary Outcome Measures:
  • Smoking abstinence [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    self-reported tobacco abstinence


Enrollment: 1488
Study Start Date: July 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277250

Locations
United States, Alabama
The University of Alabama at Birmingham - Lung Health Center
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Kathleen F Harrington, PhD, MPH The University of Alabama at Birmingham
  More Information

Publications:
CDC. Cigarette smoking among adults---United States, 2007. MMWR 2008;57:1221-1226.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kathy Harrington, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01277250     History of Changes
Other Study ID Numbers: 1U01DA031515-01
Study First Received: January 12, 2011
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Alabama at Birmingham:
Hospitalized adults
Tobacco users
Smokers
Smoking cessation
Web-based
Transition coach

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on July 26, 2014