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Smoking CessationNCT00608426

Proactive Tobacco Treatment for Veterans

A study testing Proactive Outreach with choice of telephone or in-person smoking cessation services in people with Smoking Cessation and Smoking Tobacco, run by US Department of Veterans Affairs at 5 sites 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

Tobacco use is the leading cause of premature death in the United States and disproportionately affects Veterans and certain racial/ethnic minority groups. Most smokers are interested in quitting; however, current tobacco use treatment approaches are reactive and require smokers to initiate treatment or depend on the… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Smoking Cessation, Smoking Tobacco
What is being tested?
Proactive Outreach with choice of telephone or in-person smoking cessation services
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,400 participants
Where
5 sitesUnited States
Study dates
Oct 2009to Dec 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Current smoker, identified by tobacco use clinical reminder.

Who cannot join

  • ICD-9 diagnosis of dementia (290.xx or 331.xx).
  • Greater than 10 VA mental health clinic visits in past 12 months.
  • Missing phone number or mailing address.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites
  • G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS

    Jackson, Mississippi, 39216

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417

  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

    New York, New York, 10010

  • Philadelphia VA Medical Center, Philadelphia, PA

    Philadelphia, Pennsylvania, 19104

  • James A. Haley Veterans' Hospital, Tampa, FL

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Proactive Tobacco Treatment for Diverse Veteran Smokers

Tobacco use is the leading cause of premature death in the United States and disproportionately affects Veterans and certain racial/ethnic minority groups. Most smokers are interested in quitting; however, current tobacco use treatment approaches are reactive and require smokers to initiate treatment or depend on the provider to initiate smoking cessation care. As a result, most smokers do not receive comprehensive, evidence-based treatment for tobacco use that includes intensive behavioral counseling along with pharmacotherapy. Proactive tobacco treatment integrates population-based treatment (i.e., proactive outreach) and individual-level treatment (i.e., smoking cessation counseling and pharmacotherapy) to address both patient and provider barriers to comprehensive care.

Read the detailed description
  1. BACKGROUND/RATIONALE Tobacco use remains the number one cause of premature death and morbidity in the United States. Most cigarette smokers want to quit smoking, and about 50% make a quit attempt each year, but only 6% achieve long-term cessation. This randomized controlled trial - the Veterans Victory over Tobacco Study - compared the effects of a proactive tobacco cessation care model versus a traditional cessation care model on the use of tobacco treatment and subsequent population-level smoking cessation rates. Veterans from four VAMCs were recruited from 10/09 to 9/10 and were randomized to either usual care (i.e., reactive care) or the proactive care intervention. Veterans in the usual care group (n=2,604) received access to tobacco treatment services from their VAMC. Veterans in the proactive care intervention group (n=2,519) received proactive outreach (mailed invitation materials followed by telephone outreach); and were offered a choice of smoking cessation services (telephone care or in-person care). The primary outcome was six-month prolonged smoking abstinence one year after randomization. Investigators also analyzed baseline demographics, clinical characteristics (i.e., distance to VAMC, comorbid psychiatric conditions), and smoking history.
  2. OBJECTIVES The primary objectives of this study were to (1) Assess the effect of a proactive care intervention on population-level smoking abstinence rates (i.e., abstinence among all smokers including those who use and do not use treatment) and on use of evidence-based tobacco treatments compared to reactive/usual care among a diverse population of Veteran smokers, (2) Compare the effect of proactive care on population-level smoking abstinence rates and use of tobacco treatments between African American and White smokers, and (3) Determine the cost-effectiveness of the proactive care intervention.
  3. METHODS In this prospective randomized controlled trial, we identified a population-based registry of current smokers (N=6400) from four Department of Veterans Affairs (VA) Medical Centers facilities using the VA electronic medical record, who were randomized to proactive care or usual care. The proactive care intervention combines: (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or face-to-face). Proactive outreach included mailed invitations followed by telephone outreach with motivational enhancement (up to 6 call attempts) to encourage smokers to seek treatment with choice of services. Proactive care participants who chose telephone care received VA telephone counseling and access to pharmacotherapy. Proactive care participants who chose face-to-face care were referred to their VA facility's smoking cessation clinic. Usual care group participants had access to standard smoking cessation services provided by their VA facility and their VA primary care provider. Usual care participants could also call their local state telephone quitline. Because this study was testing proactive outreach, smokers were randomized prior to contact and a baseline survey was administered after randomization using a multiple-wave mailed questionnaire protocol. Additional baseline data were extracted from VA administrative databases. Outcomes from both groups were collected 12 months post-randomization from participant surveys and from VA administrative databases. The primary outcome was population-level cessation at one year using a self-reported, 6-month prolonged smoking abstinence measure.
  4. STATUS We have successfully conducted a multi-site population-based randomized controlled trial. Our primary outcomes paper was published by the JAMA Internal Medicine online in March 2014 and we are currently working on a second manuscript.
  5. CLINICAL SIGNIFICANCE In this study, we tested a proactive care intervention that harnesses the power of the electronic medical record to identify populations of smokers in a health care system and capitalize on the availability of validated telephone care protocols to efficiently deliver intensive behavioral counseling and facilitate access to pharmacotherapy.
Being tested
Proactive Outreach with choice of telephone or in-person smoking cessation services
Keywords
African Americans, telephone counseling, community health planning, ethnic groups
Medical subject headings
Smoking Cessation, Smoking

What participants receive

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

  • Proactive Outreach with choice of telephone or in-person smoking cessation servicesBehavioural

    This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care).

Study groups in NCT00608426
Study groupRoleWhat they receive
Usual CareNo interventionGroup who can elect to receive reactive (usual) care for smoking cessation.
Proactive CareExperimentalGroup who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).
Receives: Behavioral: Proactive Outreach with choice of telephone or in-person smoking cessation services

What is being measured

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

  1. Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence

    Measured: 12 months after randomization

Secondary outcomes (2)
  1. Treatment Utilization Rates for Counseling and/or Pharmacotherapy

    Measured: 12 months after randomization

  2. 7-day Point Prevalence Abstinence

    Measured: 12 months after randomizatoin

Timeline

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

  1. First posted6 Feb 2008 (estimated)
  2. Study startOct 2009
  3. Primary completionDec 2011
  4. Study completionDec 2013

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 N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6,400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00608426
Sponsor's protocol ID
IAB 05-303
Status last verified
Mar 2014
First submitted
31 Jan 2008
Last updated
24 Apr 2015
Data monitoring committee
Yes

Publications

  • Fu SS, van Ryn M, Sherman SE, Burgess DJ, Noorbaloochi S, Clothier B, Joseph AM. Population-based tobacco treatment: study design of a randomized controlled trial. BMC Public Health. 2012 Mar 6;12:159. doi: 10.1186/1471-2458-12-159.

    PubMed 22394386
  • Fu SS, van Ryn M, Sherman SE, Burgess DJ, Noorbaloochi S, Clothier B, Taylor BC, Schlede CM, Burke RS, Joseph AM. Proactive tobacco treatment and population-level cessation: a pragmatic randomized clinical trial. JAMA Intern Med. 2014 May;174(5):671-7. doi: 10.1001/jamainternmed.2014.177.

    PubMed 24615217
  • Burgess DJ, van Ryn M, Noorbaloochi S, Clothier B, Taylor BC, Sherman S, Joseph AM, Fu SS. Smoking cessation among African American and white smokers in the Veterans Affairs health care system. Am J Public Health. 2014 Sep;104 Suppl 4(Suppl 4):S580-7. doi: 10.2105/AJPH.2014.302023.

    PubMed 25100424
  • Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

    PubMed 39868569
  • Danan ER, Sherman SE, Clothier BA, Burgess DJ, Pinsker EA, Joseph AM, Noorbaloochi S, Fu SS. Smoking Cessation among Female and Male Veterans before and after a Randomized Trial of Proactive Outreach. Womens Health Issues. 2019 Jun 25;29 Suppl 1(Suppl 1):S15-S23. doi: 10.1016/j.whi.2019.04.001.

    PubMed 31253237
  • Danan ER, Fu SS, Clothier BA, Noorbaloochi S, Hammett PJ, Widome R, Burgess DJ. The Equity Impact of Proactive Outreach to Smokers: Analysis of a Randomized Trial. Am J Prev Med. 2018 Oct;55(4):506-516. doi: 10.1016/j.amepre.2018.05.023. Epub 2018 Aug 20.

    PubMed 30139707
  • Melzer AC, Pinsker EA, Clothier B, Noorbaloochi S, Burgess DJ, Danan ER, Fu SS. Validating the use of veterans affairs tobacco health factors for assessing change in smoking status: accuracy, availability, and approach. BMC Med Res Methodol. 2018 May 11;18(1):39. doi: 10.1186/s12874-018-0501-2.

    PubMed 29751746
  • Japuntich SJ, Sherman SE, Joseph AM, Clothier B, Noorbaloochi S, Danan E, Burgess D, Rogers E, Fu SS. Proactive tobacco treatment for individuals with and without a mental health diagnosis: Secondary analysis of a pragmatic randomized controlled trial. Addict Behav. 2018 Jan;76:15-19. doi: 10.1016/j.addbeh.2017.07.024. Epub 2017 Jul 15.

    PubMed 28735036
  • Danan ER, Joseph AM, Sherman SE, Burgess DJ, Noorbaloochi S, Clothier B, Japuntich SJ, Taylor BC, Fu SS. Does Motivation Matter? Analysis of a Randomized Trial of Proactive Outreach to VA Smokers. J Gen Intern Med. 2016 Aug;31(8):878-87. doi: 10.1007/s11606-016-3687-1. Epub 2016 Apr 12.

    PubMed 27071399

Questions about this trial

What is this clinical trial studying?

A study testing Proactive Outreach with choice of telephone or in-person smoking cessation services in people with Smoking Cessation and Smoking Tobacco, run by US Department of Veterans Affairs at 5 sites 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 1 inclusion and 3 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 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence (time frame: 12 months after randomization). 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 NCT00608426, which also lists 9 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 24 Apr 2015.

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