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TeleQuit Smoking Cessation Program

Telephone Care Coordination to Improve Smoking Cessation Counseling

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00123682
Enrollment
3120
Registered
2005-07-25
Start date
2005-05-31
Completion date
2009-09-30
Last updated
2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking

Keywords

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

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: 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.

Interventions

PROCEDUREProactive outreach to counseling

Project staff reach out to engage referred smoker into telephone counseling

PROCEDUREReactive outreach to counseling

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

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

PROCEDURESelf-help

Project staff send out self-help materials for smoking cessation

Sponsors

University of California, San Diego
CollaboratorOTHER
California Smokers' Helpline
CollaboratorOTHER
US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frame
7-day Point Prevalence Abstinence From Smoking6 month

Secondary

MeasureTime frame
Use of Cessation Medications6 months
Self-reported Quit Attempt6 months

Countries

United States

Participant flow

Participants by arm

ArmCount
Proactive Referral and Intensive Telephone Counseling
Proactive referral and intensive telephone counseling
1,069
Reactive Referral and Intensive Counseling
Reactive referral and intensive counseling
934
Proactive Referral and Self-help Materials
Proactive referral and self-help materials
592
Reactive Referral and Self-help Materials
Reactive referral and self-help materials
525
Total3,120

Baseline characteristics

CharacteristicProactive Referral and Intensive Telephone CounselingTotalReactive Referral and Self-help MaterialsProactive Referral and Self-help MaterialsReactive Referral and Intensive Counseling
Age, Continuous53.7 years
STANDARD_DEVIATION 10.8
54.0 years
STANDARD_DEVIATION 11
55.1 years
STANDARD_DEVIATION 11.4
54.0 years
STANDARD_DEVIATION 11.8
54.2 years
STANDARD_DEVIATION 11.1
Cigarettes per day17.7 cigarettes per day
STANDARD_DEVIATION 9.9
18.0 cigarettes per day
STANDARD_DEVIATION 10
20.1 cigarettes per day
STANDARD_DEVIATION 11.4
17.6 cigarettes per day
STANDARD_DEVIATION 10.2
18.3 cigarettes per day
STANDARD_DEVIATION 10.3
Race (NIH/OMB)
American Indian or Alaska Native
13 Participants26 Participants5 Participants3 Participants5 Participants
Race (NIH/OMB)
Asian
31 Participants74 Participants8 Participants19 Participants16 Participants
Race (NIH/OMB)
Black or African American
231 Participants575 Participants71 Participants73 Participants200 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
189 Participants666 Participants152 Participants155 Participants170 Participants
Race (NIH/OMB)
White
605 Participants1779 Participants289 Participants342 Participants543 Participants
Sex: Female, Male
Female
55 Participants185 Participants25 Participants40 Participants65 Participants
Sex: Female, Male
Male
1014 Participants2935 Participants500 Participants552 Participants869 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 1,0690 / 9340 / 5920 / 525
serious
Total, serious adverse events
0 / 1,0690 / 9340 / 5920 / 525

Outcome results

Primary

7-day Point Prevalence Abstinence From Smoking

Time frame: 6 month

ArmMeasureValue (NUMBER)
Proactive Referral and Intensive Telephone Counseling7-day Point Prevalence Abstinence From Smoking21 percentage of participants
Reactive Referral and Intensive Counseling7-day Point Prevalence Abstinence From Smoking16.4 percentage of participants
Proactive Referral and Self-help Materials7-day Point Prevalence Abstinence From Smoking16.9 percentage of participants
Reactive Referral and Self-help Materials7-day Point Prevalence Abstinence From Smoking16.5 percentage of participants
Secondary

Self-reported Quit Attempt

Time frame: 6 months

ArmMeasureValue (NUMBER)
Proactive Referral and Intensive Telephone CounselingSelf-reported Quit Attempt74 percentage of participants
Reactive Referral and Intensive CounselingSelf-reported Quit Attempt61.3 percentage of participants
Proactive Referral and Self-help MaterialsSelf-reported Quit Attempt68.5 percentage of participants
Reactive Referral and Self-help MaterialsSelf-reported Quit Attempt63 percentage of participants
Secondary

Use of Cessation Medications

Time frame: 6 months

ArmMeasureValue (NUMBER)
Proactive Referral and Intensive Telephone CounselingUse of Cessation Medications70.1 percentage of participants
Reactive Referral and Intensive CounselingUse of Cessation Medications57.6 percentage of participants
Proactive Referral and Self-help MaterialsUse of Cessation Medications74.5 percentage of participants
Reactive Referral and Self-help MaterialsUse of Cessation Medications48.2 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026