Proactive Tobacco Treatment for Veterans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00608426
First received: January 31, 2008
Last updated: April 17, 2014
Last verified: April 2014
  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:


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
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).

  Show Detailed Description

  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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Steven S. Fu, MD MSCE Minneapolis VA Health Care System
  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 17, 2014
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 July 26, 2014