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Sponsors and Collaborators: |
Department of Veterans Affairs University of California, San Diego California Smokers' Helpline |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00123682 |
TeleQuit is a group randomized trial testing whether a telephone care coordination program increases the rate of smoking cessation treatment for VA patients at study sites. We are testing whether proactive care coordination (counselor initiates the call to the patient) is more effective than reactive coordination (coordinator waits for the patient to call); and whether multi-session counseling is more effective than brief primary care-based counseling plus self-help materials. We randomly assigned study sites to either quitline counseling or brief counseling only. All patients receive brief smoking cessation counseling from their primary care physician, smoking cessation medications (once they are in contact with the VA care coordinator), and a follow-up call at 6 months. Care coordination will be provided by VA clinical staff. Intensive counseling is provided by the California Smokers' Helpline.
Condition | Intervention |
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Smoking |
Procedure: Approach to proactive referral vs. reactive referral Procedure: Intensive telephone counseling vs. brief counseling |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Dose Comparison, Factorial Assignment, Efficacy Study |
Official Title: | Telephone Care Coordination to Improve Smoking Cessation Counseling |
Estimated Enrollment: | 25000 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1 | Procedure: Approach to proactive referral vs. reactive referral Procedure: Intensive telephone counseling vs. brief counseling |
Background:
This project aims to make smoking cessation an area of excellence for two VA networks by adapting and expanding the primary care-based Telephone Care Coordination Program (TCCP) throughout Sierra Pacific Healthcare Network (VISN 21) and Desert Pacific Healthcare Network (VISN 22). Current VA policy and new VA/DoD guidelines both mandate that patients be offered treatment (medications and counseling), regardless of whether they attend a smoking cessation program. This makes it essential to treat patients within primary care, since most smokers interested in quitting cannot or will not attend a cessation program. Current data on treatment rates in VISNs 21 and 22 show that in spite of the fact that over 60% of smokers report trying to quit in the prior year, only about 7% were actually given treatment to assist them in quitting.
This regional expansion builds on a very successful VA Substance Use Disorder QUERI demonstration project at two facilities. Across the 10 intervention sites, there were 2,900 referrals for smoking cessation in 10 months. VA care coordinators proactively contacted patients and connected them with the California Smokers' Helpline. Thus far, 45% of patients starting treatment were abstinent six months later -- equal to or better than smoking cessation clinics. A cost analysis shows substantial savings per quitter compared to provider and clinic-based programs.
Objectives:
The objectives of the study are to:
Methods:
This project is a group randomized trial testing whether TCCP increases the rate of smoking cessation treatment. At the patient level, two questions are addressed: 1) Is proactive care coordination (counselor initiates the call to the patient) more effective than reactive coordination (coordinator waits for the patient to call)? 2) Is multi-session counseling more effective than brief primary care-based counseling plus self-help materials? Using a two-by-two factorial design, we will randomly allocate all sites within VISNs 21 and 22 to one of these four groups. All patients will receive brief smoking cessation counseling from their primary care physician, smoking cessation medications (once they are in contact with the VA care coordinator), and a follow-up call at 6 months. Care coordination will be provided by VA clinical staff (donated as in-kind support from the participating facilities). Intensive counseling will be provided by the California Smokers' Helpline.
Status:
The project is fully implemented in GLA in VISN 22 and four of the six VISN 21 facilities, and data collection is under way. We have IRB approval for our evaluation plans and will begin evaluation early 2008.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
VA patient assigned to a clinic offering the program
Smoker
Patient wants to quit smoking
Exclusion Criteria:
None
United States, California | |
VA Greater Los Angeles Health Care System | |
Sepulveda, California, United States, 91343 | |
VA Palo Alto Health Care System | |
Palo Alto, California, United States, 94304-1290 | |
United States, New York | |
New York, NY | |
New York, New York, United States, 10010 |
Principal Investigator: | Scott E. Sherman, MD MPH | New York, NY |
Responsible Party: | Department of Veterans Affairs ( Sherman, Scott - Principal Investigator ) |
Study ID Numbers: | IMV 04-088, PCC 2004-081176 |
Study First Received: | July 21, 2005 |
Last Updated: | May 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00123682 |
Health Authority: | United States: Federal Government |
Smoking Cessation Care Management Substance Use Disorder QUERI |
Primary Care Regional Expansion Telephone |
Smoking |
Habits |