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

Cigarette Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277250
• Other study ID #: 1U01DA031515
• Status: Completed
• Phase: Phase 4
• First received: January 12, 2011
• Last updated: June 17, 2015
• Start date: July 2011
• Est. completion date: November 2014

Study information

• Verified date: June 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1548
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cigarette Smoking
• Cognitively and Physically Able to Participate
• English Speaking and Reading
• Home Access to Internet and Email

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham - Lung Health Center	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

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* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking abstinence	Biochemically-verified (cotinine) and self-reported tobacco abstinence	6 months	No
Secondary	Smoking abstinence	self-reported tobacco abstinence	3 and 12 months	No