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Proactive Tobacco Treatment for Veterans

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00608426
First received: January 31, 2008
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Smoking Cessation
Smoking Tobacco
 Behavioral: Proactive Outreach with choice of telephone or in-person smoking cessation services

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Proactive Tobacco Treatment for Diverse Veteran Smokers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Self-reported, smoking abstinence rates. 1) 6-month prolonged abstinence, 2) 7-day point prevalence abstinence, and 3) 30-day duration of abstinence [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VA tobacco treatment utilization rates for counseling and/or pharmacotherapy [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]

Enrollment: 6400
Study Start Date: October 2009
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm 1
Group who can elect to receive reactive (usual) care for smoking cessation.
Experimental: Arm 2
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).

Detailed Description:
  1. BACKGROUND/RATIONALE 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.
  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. The primary outcome analyses have been completed and manuscripts presenting these results are being prepared for publication. The cost-effectiveness and secondary analyses are ongoing.
  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 capitalizes on the availability of validated telephone care protocols to efficiently deliver intensive behavioral counseling and facilitate access to pharmacotherapy.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current smoker, identified by tobacco use clinical reminder.

Exclusion Criteria:

  1. ICD-9 diagnosis of dementia (290.xx or 331.xx).
  2. Greater than 10 VA mental health clinic visits in past 12 months.
  3. Missing phone number or mailing address.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608426

Locations
United States, Florida
James A. Haley Veterans Hospital
Tampa, Florida, United States, 33612
United States, Minnesota
Academy Health Center Departments
Minneapolis, Minnesota, United States, 55417
United States, Mississippi
G.V. (Sonny) Montgomery VA Medical Center, Jackson
Jackson, Mississippi, United States, 39216
United States, New York
New York, NY
New York, New York, United States, 10010
United States, Pennsylvania
Division of General Internal Medicine
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Steven S. Fu, MD MSCE Department of Veterans Affairs
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00608426     History of Changes
Other Study ID Numbers: IAB 05-303
Study First Received: January 31, 2008
Last Updated: April 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
African Americans
telephone counseling
community health planning
ethnic groups

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 23, 2013