TeleQuit Smoking Cessation Program

• ClinicalTrials.gov Identifier: NCT00123682
• Recruitment Status: Completed
• First Posted: July 25, 2005
• Results First Posted: February 26, 2015
• Last Update Posted: March 17, 2015
• Sponsor: US Department of Veterans Affairs
• Collaborators: University of California, San Diego; California Smokers' Helpline
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Smoking	Procedure: Proactive outreach to counseling; Procedure: Reactive outreach to counseling; Procedure: Intensive counseling; Procedure: Self-help	Not Applicable

Detailed Description:

Background:

Despite 40 years of progress, smoking remains the leading preventable cause of death in the United States, responsible for 435,000 deaths per year. Smoking is a particular problem within the VA, as VA users smoke substantially more than the general population across all categories of sex, age, and race. When adjusted for age and gender, the rate of smoking among VA users is 10% higher than the general US population - 33% vs. 23%. The prevalence of heavy tobacco users (defined as >20 cigarettes per day) in the VA is more than double that of the non-VA U.S. population (7.4% vs. 3.5%).

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. Thus it is essential to treat patients within primary care, since most smokers interested in quitting cannot or will not attend a cessation program.

Objectives:

This project sought 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 Greater Los Angeles Healthcare System (VISN 22).

This regional expansion built on the TCCP, a very successful VA Substance Use Disorder QUERI demonstration project implemented at two facilities. In the demonstration project, 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. About 45% of patients starting treatment were abstinent six months later--equal to or better than smoking cessation clinics. A cost analysis showed substantial savings per quitter compared to provider-based and clinic-based programs.

Methods:

We developed a telephone-based smoking cessation program that was integrated as a routine clinical care option at five VISN 21 and VISN 22 facilities (38 clinic sites). Referrals to the program were generated by a provider during a visit through a brief consult in CPRS. Program staff then recruited patients and, after obtaining consent, enrolled the patients into treatment. Data were collected at the site level (quantity of referrals, service origins, etc.) and at the patient level (demographics, enrollment rates, abstinence rates at six months, etc.).

This project was a group randomized trial testing of whether telephone care coordination 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?

We randomly allocated all participating sites within VISNs 21 and 22 to either self-help or intensive counseling treatment arms. We randomly allocated each week of program referrals to either proactive or reactive care coordination. All patients received brief smoking cessation counseling from their primary care physician, smoking cessation medications (after study enrollment by the VA care coordinator), and a follow-up call at 6 months. Care coordination was provided by VA clinical staff (donated as in-kind support from the participating facilities). Intensive counseling was provided by the California Smokers' Helpline.

Status:

Complete except for ongoing data analysis.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3120 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Telephone Care Coordination to Improve Smoking Cessation Counseling
• Study Start Date: May 2005
• Actual Primary Completion Date: March 2009
• Actual Study Completion Date: September 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1 - proactive, intensive counseling; Proactive outreach to counseling; multi-session counseling from California Smokers' Helpline	Procedure: Proactive outreach to counseling; Project staff reach out to engage referred smoker into telephone counseling; Procedure: Intensive counseling; Multi-session telephone counseling, delivered by California Smokers' Helpline
Experimental: Arm 2 - reactive, intensive counseling; Reactive outreach to counseling; multi-session counseling from California Smokers' Helpline	Procedure: Reactive outreach to counseling; Project staff send a letter to referred smoker, asking them to call to engage in telephone counseling; Procedure: Intensive counseling; Multi-session telephone counseling, delivered by California Smokers' Helpline
Experimental: Arm 3 - proactive, self-help; Proactive outreach to engage smoker in treatment; mailed self-help materials	Procedure: Proactive outreach to counseling; Project staff reach out to engage referred smoker into telephone counseling; Procedure: Self-help; Project staff send out self-help materials for smoking cessation
Experimental: Arm 4 - reactive, self-help; Reactive approach to engaging smoker in treatment; mailed self-help materials	Procedure: Reactive outreach to counseling; Project staff send a letter to referred smoker, asking them to call to engage in telephone counseling; Procedure: Self-help; Project staff send out self-help materials for smoking cessation

Outcome Measures

Primary Outcome Measures :

1. 7-day Point Prevalence Abstinence From Smoking [ Time Frame: 6 month ]

Secondary Outcome Measures :

1. Use of Cessation Medications [ Time Frame: 6 months ]
2. Self-reported Quit Attempt [ Time Frame: 6 months ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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

Locations

United States, California

VA Palo Alto Health Care System

Palo Alto, California, United States, 94304-1290

VA Greater Los Angeles Healthcare System, Sepulveda

Sepulveda, California, United States, 91311

United States, New York

New York, NY

New York, New York, United States, 10010

Sponsors and Collaborators

US Department of Veterans Affairs

University of California, San Diego

California Smokers' Helpline

Investigators

• Principal Investigator: Scott E Sherman, MD MPH; New York, NY

More Information

Publications of Results:

Fu SS, Sherman SE, Yano EM, van Ryn M, Lanto AB, Joseph AM. Ethnic disparities in the use of nicotine replacement therapy for smoking cessation in an equal access health care system. Am J Health Promot. 2005 Nov-Dec;20(2):108-16.

Sherman SE, Takahashi N, Kalra P, Gifford E, Finney JW, Canfield J, Kelly JF, Joseph GJ, Kuschner W. Care coordination to increase referrals to smoking cessation telephone counseling: a demonstration project. Am J Manag Care. 2008 Mar;14(3):141-8.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sherman SE, Krebs P, York LS, Cummins SE, Kuschner W, Guvenc-Tuncturk S, Zhu SH. Telephone care co-ordination for tobacco cessation: randomised trials testing proactive versus reactive models. Tob Control. 2018 Jan;27(1):78-82. doi: 10.1136/tobaccocontrol-2016-053327. Epub 2017 Feb 11.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00123682
• Other Study ID Numbers: IMV 04-088
• First Posted: July 25, 2005
• Results First Posted: February 26, 2015
• Last Update Posted: March 17, 2015
• Last Verified: February 2015

Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):

Smoking Cessation; Care Management; Substance Use Disorder QUERI; Primary Care; Regional Expansion; Telephone