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.
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
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:
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| Arm 1 - proactive, intensive counseling | Experimental | Proactive outreach to counseling; multi-session counseling from California Smokers' Helpline Receives: Procedure: Proactive outreach to counseling; Procedure: Intensive counseling |
| Arm 2 - reactive, intensive counseling | Experimental | Reactive outreach to counseling; multi-session counseling from California Smokers' Helpline Receives: Procedure: Reactive outreach to counseling; Procedure: Intensive counseling |
| Arm 3 - proactive, self-help | Experimental | Proactive outreach to engage smoker in treatment; mailed self-help materials Receives: Procedure: Proactive outreach to counseling; Procedure: Self-help |
| Arm 4 - reactive, self-help | Experimental | Reactive 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.
7-day Point Prevalence Abstinence From Smoking
Measured: 6 month
Secondary outcomes (2)
Use of Cessation Medications
Measured: 6 months
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.
- First posted25 Jul 2005 (estimated)
- Study startMay 2005
- Primary completionMar 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- University of California, San Diego, California Smokers' Helpline
- Responsible party
- Sponsor
- Investigators
- Scott E Sherman, MD MPH, Principal investigator, New York, NY
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 16295702Sherman 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 18333706Sherman 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Care Coordination to Improve Smoking Cessation Counseling
- ClinicalTrials.gov ID
- NCT00123682
- Acronym / sponsor ID
- IMV 04-088
- Conditions
- Smoking
- Keywords
- Smoking Cessation, Care Management, Substance Use Disorder QUERI, Primary Care, Regional Expansion, Telephone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,120 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- University of California, San Diego, California Smokers' Helpline
- Study start
- May 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 Jul 2005 (estimated)
- Results
- Posted 26 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - proactive, intensive counseling | Experimental | Procedure: Proactive outreach to counseling, Procedure: Intensive counselingProactive outreach to counseling; multi-session counseling from California Smokers' Helpline |
| Arm 2 - reactive, intensive counseling | Experimental | Procedure: Reactive outreach to counseling, Procedure: Intensive counselingReactive outreach to counseling; multi-session counseling from California Smokers' Helpline |
| Arm 3 - proactive, self-help | Experimental | Procedure: Proactive outreach to counseling, Procedure: Self-helpProactive outreach to engage smoker in treatment; mailed self-help materials |
| Arm 4 - reactive, self-help | Experimental | Procedure: Reactive outreach to counseling, Procedure: Self-helpReactive approach to engaging smoker in treatment; mailed self-help materials |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- VA patient assigned to a clinic offering the program
- Smoker
- Patient wants to quit smoking
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive outreach to counselingProject staff reach out to engage referred smoker into telephone counseling | Procedure or surgery | Arm 1 - proactive, intensive counseling, Arm 3 - proactive, self-help |
| Reactive outreach to counselingProject staff send a letter to referred smoker, asking them to call to engage in telephone counseling | Procedure or surgery | Arm 2 - reactive, intensive counseling, Arm 4 - reactive, self-help |
| Intensive counselingMulti-session telephone counseling, delivered by California Smokers' Helpline | Procedure or surgery | Arm 1 - proactive, intensive counseling, Arm 2 - reactive, intensive counseling |
| Self-helpProject staff send out self-help materials for smoking cessation | Procedure or surgery | Arm 3 - proactive, self-help, Arm 4 - reactive, self-help |
Primary outcome
7-day Point Prevalence Abstinence From Smoking
Time frame: 6 month
2 secondary outcomes
Use of Cessation Medications
Time frame: 6 months
Self-reported Quit Attempt
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 16295702Fu 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.
- Results publication: PubMed 18333706Sherman 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.
- Derived from this study: PubMed 28190003Sherman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott E Sherman, MD MPH principal investigator
New York, NY
3 sites in 1 country: see every site and its status.
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.