AzTrials
AzTrials

SmokingNCT00123682

TeleQuit Smoking Cessation Program

A study testing Proactive outreach to counseling, Reactive outreach to counseling and Intensive counseling in people with Smoking, run by US Department of Veterans Affairs at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Smoking
What is being tested?
Proactive outreach to counseling, Reactive outreach to counseling and Intensive counseling
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,120 participants
Where
3 sitesUnited States
Study dates
May 2005to Sep 2009
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • VA patient assigned to a clinic offering the program
  • Smoker
  • Patient wants to quit smoking

Who cannot join

  • None

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • New York, NY

    New York, New York, 10010

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304-1290

  • VA Greater Los Angeles Healthcare System, Sepulveda

    Sepulveda, California, 91311

Other trials in United States

About this study

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.

Read the 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.

Conditions
Smoking
Being tested
Proactive outreach to counseling, Reactive outreach to counseling, Intensive counseling, Self-help
Keywords
Smoking Cessation, Care Management, Substance Use Disorder QUERI, Primary Care, Regional Expansion, Telephone
Medical subject headings
Smoking, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proactive outreach to counselingProcedure or surgery

    Project staff reach out to engage referred smoker into telephone counseling

  • Reactive outreach to counselingProcedure or surgery

    Project staff send a letter to referred smoker, asking them to call to engage in telephone counseling

  • Intensive counselingProcedure or surgery

    Multi-session telephone counseling, delivered by California Smokers' Helpline

  • Self-helpProcedure or surgery

    Project staff send out self-help materials for smoking cessation

Study groups in NCT00123682
Study groupRoleWhat they receive
Arm 1 - proactive, intensive counselingExperimentalProactive outreach to counseling; multi-session counseling from California Smokers' Helpline
Receives: Procedure: Proactive outreach to counseling; Procedure: Intensive counseling
Arm 2 - reactive, intensive counselingExperimentalReactive outreach to counseling; multi-session counseling from California Smokers' Helpline
Receives: Procedure: Reactive outreach to counseling; Procedure: Intensive counseling
Arm 3 - proactive, self-helpExperimentalProactive outreach to engage smoker in treatment; mailed self-help materials
Receives: Procedure: Proactive outreach to counseling; Procedure: Self-help
Arm 4 - reactive, self-helpExperimentalReactive approach to engaging smoker in treatment; mailed self-help materials
Receives: Procedure: Reactive outreach to counseling; Procedure: Self-help

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 7-day Point Prevalence Abstinence From Smoking

    Measured: 6 month

Secondary outcomes (2)
  1. Use of Cessation Medications

    Measured: 6 months

  2. Self-reported Quit Attempt

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionMar 2009
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
3,120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00123682
Sponsor's protocol ID
IMV 04-088
Status last verified
Feb 2015
First submitted
21 Jul 2005
Last updated
17 Mar 2015
Data monitoring committee
No

Publications

  • 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. doi: 10.4278/0890-1171-20.2.108.

    PubMed 16295702
  • 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.

    PubMed 18333706
  • 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.

    PubMed 28190003

Questions about this trial

What is this clinical trial studying?

A study testing Proactive outreach to counseling, Reactive outreach to counseling and Intensive counseling in people with Smoking, run by US Department of Veterans Affairs at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

7-day Point Prevalence Abstinence From Smoking (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00123682, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.

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