Proactive Tobacco Treatment for Veterans
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|ClinicalTrials.gov Identifier: NCT00608426|
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : January 9, 2015
Last Update Posted : April 24, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation Smoking Tobacco||Behavioral: Proactive Outreach with choice of telephone or in-person smoking cessation services||Not Applicable|
- 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.
- 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.
- 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.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Proactive Tobacco Treatment for Diverse Veteran Smokers|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2013|
No Intervention: Usual Care
Group who can elect to receive reactive (usual) care for smoking cessation.
Experimental: Proactive Care
Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).
Behavioral: Proactive Outreach with choice of telephone or in-person smoking cessation services
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).
- Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence [ Time Frame: 12 months after randomization ]
- Treatment Utilization Rates for Counseling and/or Pharmacotherapy [ Time Frame: 12 months after randomization ]
- 7-day Point Prevalence Abstinence [ Time Frame: 12 months after randomizatoin ]
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Current smoker, identified by tobacco use clinical reminder.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608426
|United States, Florida|
|James A. Haley Veterans' Hospital, Tampa, FL|
|Tampa, Florida, United States, 33612|
|United States, Minnesota|
|Minneapolis VA Health Care System, Minneapolis, MN|
|Minneapolis, Minnesota, United States, 55417|
|United States, Mississippi|
|G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS|
|Jackson, Mississippi, United States, 39216|
|United States, New York|
|Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY|
|New York, New York, United States, 10010|
|United States, Pennsylvania|
|Philadelphia VA Medical Center, Philadelphia, PA|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Steven S. Fu, MD MSCE||Minneapolis VA Health Care System, Minneapolis, MN|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||US Department of Veterans Affairs|
|Other Study ID Numbers:||
|First Posted:||February 6, 2008 Key Record Dates|
|Results First Posted:||January 9, 2015|
|Last Update Posted:||April 24, 2015|
|Last Verified:||March 2014|
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