Proactive Tobacco Treatment for Veterans

Not Applicable

Completed

• Conditions: Smoking Tobacco; Smoking Cessation
• Interventions: Behavioral: Proactive Outreach with choice of telephone or in-person smoking cessation services

• Registration Number: NCT00608426
• Lead Sponsor: US Department of Veterans Affairs

Brief 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.

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.

Study Timeline

• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-02-05
• Study First Posted: 2008-02-06
• Study Start: 2009-10
• Primary Completion: 2011-12
• Study Completion: 2013-12
• Status Verified: 2014-03
• Results First Submitted: 2014-06-06
• Results First Submitted QC: 2014-12-22
• Results First Posted: 2015-01-09
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6400

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proactive Care	Proactive Outreach with choice of telephone or in-person smoking cessation services	Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).

Primary Outcome Measures

Name	Time	Method
Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence	12 months after randomization

Secondary Outcome Measures

Name	Time	Method
7-day Point Prevalence Abstinence	12 months after randomizatoin
Treatment Utilization Rates for Counseling and/or Pharmacotherapy	12 months after randomization

Trial Locations

Locations (5)

G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS; 🇺🇸 Jackson, Mississippi, 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

Minneapolis VA Health Care System, Minneapolis, MN; 🇺🇸 Minneapolis, Minnesota, United States

James A. Haley Veterans' Hospital, Tampa, FL; 🇺🇸 Tampa, Florida, United States