Proactive Tobacco Treatment for Veterans - Full Text View

Purpose

The purpose of this research study is to assess whether a population-level proactive tobacco treatment strategy combining 1) proactive outreach and 2) choice of smoking cessation services (telephone care or in-person care) will be more effective than current, reactive (i.e., usual care) approaches in linking smokers with appropriate treatment to quit smoking.

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

MedlinePlus related topics:

Quitting Smoking Smoking

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Proactive Tobacco Treatment for Diverse Veteran Smokers

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 ]

Estimated Enrollment:	4320
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Group who can elect to receive reactive (usual) care for smoking cessation.
2: Experimental 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).

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Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608426

Contacts


Contact: Alicia Sandberg, BA	(612) 467-1539	alicia.sandberg@va.gov

Contact: Diana J Burgess, PhD	(612) 467-1591	diana.burgess@med.va.gov

Locations


United States, Florida
	James A. Haley Veterans Hospital, Tampa
	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
	VA Medical Center, Philadelphia
	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

Responsible Party:	Department of Veterans Affairs ( Fu, Steven - Principal Investigator )
Study ID Numbers:	IAB 05-303
First Received:	January 31, 2008
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00608426
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

African Americans

telephone counseling

community health planning

ethnic groups

Study placed in the following topic categories:

Smoking

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on November 03, 2008

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00608426