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Cigarette SmokingPhase 4NCT01277250

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

A Phase 4 study testing Web-based smoking cessation program in people with Cigarette Smoking and Home Access to Internet and Email, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Web-based smoking cessation program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,548 participants
Where
1 siteUnited States
Study dates
Jul 2011to Nov 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Alabama at Birmingham - Lung Health Center

    Birmingham, Alabama, 35294

Other trials in United States

About this study

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.

Being tested
Web-based smoking cessation program
Keywords
Hospitalized adults, Tobacco users, Smokers, Smoking cessation, Web-based, Transition coach
Medical subject headings
Cigarette Smoking, Tobacco Use, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web-based smoking cessation programBehavioural

    Also called Tobacco Treatment, Behavioral Counseling, Computer-Assisted Treatment

    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.

Study groups in NCT01277250
Study groupRoleWhat they receive
Usual CareOtherStandard smoking cessation information provided to all hospitalized patients as part of discharge packet.
Receives: Behavioral: Web-based smoking cessation program
Smoking Cessation ProgramExperimentalWeb-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.
Receives: Behavioral: Web-based smoking cessation program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Smoking abstinence

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

    Measured: 6 months

Secondary outcomes (1)

  1. Smoking abstinence

    self-reported tobacco abstinence

    Measured: 3 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionSep 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,548 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01277250
Sponsor's protocol ID
1U01DA031515
Status last verified
Jun 2015
First submitted
12 Jan 2011
Last updated
19 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Centers for Disease Control and Prevention (CDC). Cigarette smoking among adults--United States, 2007. MMWR Morb Mortal Wkly Rep. 2008 Nov 14;57(45):1221-6.

    PubMed 19008790

  • Centers for Disease Control and Prevention (CDC). State-specific prevalence and trends in adult cigarette smoking--United States, 1998-2007. MMWR Morb Mortal Wkly Rep. 2009 Mar 13;58(9):221-6.

    PubMed 19282813

  • Boyle RG, Solberg LI, Asche SE, Maciosek MV, Boucher JL, Pronk NP. Proactive recruitment of health plan smokers into telephone counseling. Nicotine Tob Res. 2007 May;9(5):581-9. doi: 10.1080/14622200701243201.

    PubMed 17454714

  • Rigotti NA, Munafo MR, Stead LF. Smoking cessation interventions for hospitalized smokers: a systematic review. Arch Intern Med. 2008 Oct 13;168(18):1950-60. doi: 10.1001/archinte.168.18.1950.

    PubMed 18852395

  • Mohiuddin SM, Mooss AN, Hunter CB, Grollmes TL, Cloutier DA, Hilleman DE. Intensive smoking cessation intervention reduces mortality in high-risk smokers with cardiovascular disease. Chest. 2007 Feb;131(2):446-52. doi: 10.1378/chest.06-1587.

    PubMed 17296646

  • Katz A, Goldberg D, Smith J, Trick WE. Tobacco, alcohol, and drug use among hospital patients: concurrent use and willingness to change. J Hosp Med. 2008 Sep;3(5):369-75. doi: 10.1002/jhm.358.

    PubMed 18951399

  • Division of Chronic Disease Prevention and Control. Illinois Department of Public Health Tobacco Burden in Illinois 2005. Springfield, IL: Illinois Department of Public Health; 2005.

  • Reid RD, Mullen KA, Slovinec D'Angelo ME, Aitken DA, Papadakis S, Haley PM, McLaughlin CA, Pipe AL. Smoking cessation for hospitalized smokers: an evaluation of the "Ottawa Model". Nicotine Tob Res. 2010 Jan;12(1):11-8. doi: 10.1093/ntr/ntp165. Epub 2009 Nov 10.

    PubMed 19903737

  • Shields M. Smoking-prevalence, bans and exposure to second-hand smoke. Health Rep. 2007 Aug;18(3):67-85. No abstract available.

    PubMed 17892252

  • Benowitz NL, Schultz KE, Haller CA, Wu AH, Dains KM, Jacob P 3rd. Prevalence of smoking assessed biochemically in an urban public hospital: a rationale for routine cotinine screening. Am J Epidemiol. 2009 Oct 1;170(7):885-91. doi: 10.1093/aje/kwp215. Epub 2009 Aug 27.

    PubMed 19713287

  • California Department of Health Services, Section TC. Adult Smoking Prevalence. http.//www.dhs.ca.gov/tobacco. Accessed January 6, 2010.

  • The Joint Commission. Comprehensive Accreditation Manual for Hospitals. http://www.jcrinc.com/Joint-Commission-Requirements/Hospitals/. Accessed January 13, 2010.

  • Freund M, Campbell E, Paul C, Sakrouge R, Lecathelinais C, Knight J, Wiggers J, Walsh RA, Jones T, Girgis A, Nagle A. Increasing hospital-wide delivery of smoking cessation care for nicotine-dependent in-patients: a multi-strategic intervention trial. Addiction. 2009 May;104(5):839-49. doi: 10.1111/j.1360-0443.2009.02520.x. Epub 2009 Mar 13.

    PubMed 19344446

  • Center for Medicare and Medicaid Services. Electronic Medical Records. http://search.cms.hhs.gov/search?q=electronic+medical+record&site=cms_collection&output=xml_no_dtd&client=cms_frontend&proxystylesheet=cms_frontend&oe=UTF-8&ie=UTF-8&ip=10.10.4.252&access=p&sort=date%3AD%3AL%3Ad1&entqr=0&ud=1&start=10. Accessed January 12, 2010.

  • CDC. Tobacco-Related Costs and Expenditure in the United States. http://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/index.htm. Accessed January 13, 2010.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Web-based smoking cessation program in people with Cigarette Smoking and Home Access to Internet and Email, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking abstinence (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01277250, which also lists 57 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2015.

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