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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00608426
Other study ID # IAB 05-303
Secondary ID
Status Completed
Phase N/A
First received January 31, 2008
Last updated April 6, 2015
Start date October 2009
Est. completion date December 2013

Study information

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

Clinical 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 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.


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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

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).

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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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