TeleQuit Smoking Cessation Program

Study Overview
=================
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.

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: Is proactive care coordination (counselor initiates the call to the patient) more effective than reactive coordination (coordinator waits for the patient to call)? 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.

Official Title
-----------------
Telephone Care Coordination to Improve Smoking Cessation Counseling

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Procedure: Proactive outreach to counseling
* Procedure: Reactive outreach to counseling
* Procedure: Intensive counseling
* Procedure: Self-help


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: VA patient assigned to a clinic offering the program Smoker Patient wants to quit smoking Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day Point Prevalence Abstinence From Smoking |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of Cessation Medications |  | 6 months | 
| Self-reported Quit Attempt |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Care Management, Smoking Cessation, Substance Use Disorder QUERI, Primary Care, Regional Expansion, Telephone