Smoking Clinical Trial
Official title:
Telephone Care Coordination to Improve Smoking Cessation Counseling
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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