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TeleQuit Smoking Cessation Program
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Department of Veterans Affairs
University of California, San Diego
California Smokers' Helpline
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00123682
  Purpose

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
Smoking
Procedure: Approach to proactive referral vs. reactive referral
Procedure: Intensive telephone counseling vs. brief counseling

MedlinePlus related topics: Quitting Smoking Smoking Smoking and Youth
U.S. FDA Resources
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

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Abstinence from smoking and smoking cessation treatment rates. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Counseling rates [ Designated as safety issue: No ]

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

Detailed Description:

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:

  1. Determine the effect of the Telephone Care Coordination Program on increasing smoking cessation treatment rates.
  2. Determine how a proactive approach to telephone counseling compares with a reactive approach.
  3. Determine how intensive telephone counseling compares with brief PC-based counseling plus self-help materials.
  4. Gather information needed for possible national implementation of this approach to smoking cessation, including feasibility, acceptability, impact and cost

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

VA patient assigned to a clinic offering the program

Smoker

Patient wants to quit smoking

Exclusion Criteria:

None

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123682

Locations
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
Sponsors and Collaborators
University of California, San Diego
California Smokers' Helpline
Investigators
Principal Investigator: Scott E. Sherman, MD MPH New York, NY
  More Information

Publications of Results:
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

Keywords provided by Department of Veterans Affairs:
Smoking Cessation
Care Management
Substance Use Disorder QUERI
Primary Care
Regional Expansion
Telephone

Study placed in the following topic categories:
Smoking

Additional relevant MeSH terms:
Habits

ClinicalTrials.gov processed this record on January 16, 2009