Smoking Cessation Clinical Trial
Official title:
Proactive Tobacco Treatment for Diverse Veteran Smokers
Verified date | March 2014 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6400 |
Est. completion date | December 2013 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Current smoker, identified by tobacco use clinical reminder. Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS | Jackson | Mississippi |
United States | Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota |
United States | Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | New York | New York |
United States | Philadelphia VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania |
United States | James A. Haley Veterans' Hospital, Tampa, FL | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
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:S580-7. doi: 10.2105 — View Citation
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. — View Citation
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. do — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence | 12 months after randomization | No | |
Secondary | Treatment Utilization Rates for Counseling and/or Pharmacotherapy | 12 months after randomization | No | |
Secondary | 7-day Point Prevalence Abstinence | 12 months after randomizatoin | No |
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