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Proactive Tobacco Treatment for Veterans

Proactive Tobacco Treatment for Diverse Veteran Smokers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00608426
Enrollment
6400
Registered
2008-02-06
Start date
2009-10-31
Completion date
2013-12-31
Last updated
2015-04-24

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

Conditions

Smoking Cessation, Smoking Tobacco

Keywords

African Americans, telephone counseling, community health planning, ethnic groups

Brief summary

Tobacco use is the leading cause of premature death in the United States and disproportionately affects Veterans and certain racial/ethnic minority groups. Most smokers are interested in quitting; however, current tobacco use treatment approaches are reactive and require smokers to initiate treatment or depend on the provider to initiate smoking cessation care. As a result, most smokers do not receive comprehensive, evidence-based treatment for tobacco use that includes intensive behavioral counseling along with pharmacotherapy. Proactive tobacco treatment integrates population-based treatment (i.e., proactive outreach) and individual-level treatment (i.e., smoking cessation counseling and pharmacotherapy) to address both patient and provider barriers to comprehensive care.

Detailed description

1. BACKGROUND/RATIONALE Tobacco use remains the number one cause of premature death and morbidity in the United States. Most cigarette smokers want to quit smoking, and about 50% make a quit attempt each year, but only 6% achieve long-term cessation. This randomized controlled trial - the Veterans Victory over Tobacco Study - compared the effects of a proactive tobacco cessation care model versus a traditional cessation care model on the use of tobacco treatment and subsequent population-level smoking cessation rates. Veterans from four VAMCs were recruited from 10/09 to 9/10 and were randomized to either usual care (i.e., reactive care) or the proactive care intervention. Veterans in the usual care group (n=2,604) received access to tobacco treatment services from their VAMC. Veterans in the proactive care intervention group (n=2,519) received proactive outreach (mailed invitation materials followed by telephone outreach); and were offered a choice of smoking cessation services (telephone care or in-person care). The primary outcome was six-month prolonged smoking abstinence one year after randomization. Investigators also analyzed baseline demographics, clinical characteristics (i.e., distance to VAMC, comorbid psychiatric conditions), and smoking history. 2. OBJECTIVES The primary objectives of this study were to (1) Assess the effect of a proactive care intervention on population-level smoking abstinence rates (i.e., abstinence among all smokers including those who use and do not use treatment) and on use of evidence-based tobacco treatments compared to reactive/usual care among a diverse population of Veteran smokers, (2) Compare the effect of proactive care on population-level smoking abstinence rates and use of tobacco treatments between African American and White smokers, and (3) Determine the cost-effectiveness of the proactive care intervention. 3. METHODS In this prospective randomized controlled trial, we identified a population-based registry of current smokers (N=6400) from four Department of Veterans Affairs (VA) Medical Centers facilities using the VA electronic medical record, who were randomized to proactive care or usual care. The proactive care intervention combines: (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or face-to-face). Proactive outreach included mailed invitations followed by telephone outreach with motivational enhancement (up to 6 call attempts) to encourage smokers to seek treatment with choice of services. Proactive care participants who chose telephone care received VA telephone counseling and access to pharmacotherapy. Proactive care participants who chose face-to-face care were referred to their VA facility's smoking cessation clinic. Usual care group participants had access to standard smoking cessation services provided by their VA facility and their VA primary care provider. Usual care participants could also call their local state telephone quitline. Because this study was testing proactive outreach, smokers were randomized prior to contact and a baseline survey was administered after randomization using a multiple-wave mailed questionnaire protocol. Additional baseline data were extracted from VA administrative databases. Outcomes from both groups were collected 12 months post-randomization from participant surveys and from VA administrative databases. The primary outcome was population-level cessation at one year using a self-reported, 6-month prolonged smoking abstinence measure. 4. STATUS We have successfully conducted a multi-site population-based randomized controlled trial. Our primary outcomes paper was published by the JAMA Internal Medicine online in March 2014 and we are currently working on a second manuscript. 5. CLINICAL SIGNIFICANCE In this study, we tested a proactive care intervention that harnesses the power of the electronic medical record to identify populations of smokers in a health care system and capitalize on the availability of validated telephone care protocols to efficiently deliver intensive behavioral counseling and facilitate access to pharmacotherapy.

Interventions

BEHAVIORALProactive Outreach with choice of telephone or in-person smoking cessation services

This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care).

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Current smoker, identified by tobacco use clinical reminder.

Exclusion criteria

* ICD-9 diagnosis of dementia (290.xx or 331.xx). * Greater than 10 VA mental health clinic visits in past 12 months. * Missing phone number or mailing address.

Design outcomes

Primary

MeasureTime frame
Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence12 months after randomization

Secondary

MeasureTime frame
Treatment Utilization Rates for Counseling and/or Pharmacotherapy12 months after randomization
7-day Point Prevalence Abstinence12 months after randomizatoin

Countries

United States

Participant flow

Pre-assignment details

At the time of the baseline survey, 1277 subjects were excluded for not meeting eligiblitiy criteria: 428 declined to participate; 201 were misclassfied as cigarette smokers (never used cigarettes or smokeless tobacco user); 444 were former smokers (rather than current smokers); 179 had incorrect mailing addresses; and 25 were deceased.

Participants by arm

ArmCount
Usual Care
Group who can elect to receive reactive (usual) care for smoking cessation.
2,604
Proactive Care
Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care). Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care).
2,519
Total5,123

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath3236
Overall StudyLost to Follow-up485521
Overall Studyrefused, health issues, wrong address319348

Baseline characteristics

CharacteristicUsual CareProactive CareTotal
Age, Continuous56.4 years
STANDARD_DEVIATION 10.2
55.8 years
STANDARD_DEVIATION 15.1
56.1 years
STANDARD_DEVIATION 14.3
Anxiety Disorder
No
2357 participants2230 participants4587 participants
Anxiety Disorder
Yes
247 participants289 participants536 participants
Depression
No
2039 participants1967 participants4006 participants
Depression
Yes
565 participants552 participants1117 participants
Distance to the VA hospital, miles
>10-25
698 participants662 participants1360 participants
Distance to the VA hospital, miles
>25-50
425 participants436 participants861 participants
Distance to the VA hospital, miles
<5
212 participants174 participants386 participants
Distance to the VA hospital, miles
>50
797 participants791 participants1588 participants
Distance to the VA hospital, miles
5-10
472 participants456 participants928 participants
Married
Married
1156 participants1108 participants2264 participants
Married
Not Married
1448 participants1411 participants2859 participants
Other psychiatric disorder
No
2174 participants2103 participants4277 participants
Other psychiatric disorder
Yes
430 participants416 participants846 participants
Other substance use disorder
No
2070 participants2038 participants4108 participants
Other substance use disorder
Yes
534 participants481 participants1015 participants
Post-traumatic stress disorder
No
2388 participants2303 participants4691 participants
Post-traumatic stress disorder
Yes
216 participants216 participants432 participants
Presence of psychiatric co-morbidity
None
1383 participants1335 participants2718 participants
Presence of psychiatric co-morbidity
One
612 participants605 participants1217 participants
Presence of psychiatric co-morbidity
Two or more
609 participants579 participants1188 participants
Race/Ethnicity, Customized
Black
568 participants595 participants1163 participants
Race/Ethnicity, Customized
Hispanic
120 participants111 participants231 participants
Race/Ethnicity, Customized
Other
203 participants210 participants413 participants
Race/Ethnicity, Customized
White
1713 participants1603 participants3316 participants
Serious mental illness
No
2427 participants2358 participants4785 participants
Serious mental illness
Yes
177 participants161 participants338 participants
Sex: Female, Male
Female
158 Participants141 Participants299 Participants
Sex: Female, Male
Male
2446 Participants2378 Participants4824 Participants
Smoking related cancer
Cancer
57 participants71 participants128 participants
Smoking related cancer
No cancer
2547 participants2448 participants4995 participants
Smoking related cardiovascular disease
No
1901 participants1842 participants3743 participants
Smoking related cardiovascular disease
Yes
703 participants677 participants1380 participants
Smoking related respiratory disease
No
2104 participants2061 participants4165 participants
Smoking related respiratory disease
Yes
500 participants458 participants958 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 2,6040 / 2,519
serious
Total, serious adverse events
0 / 2,6040 / 2,519

Outcome results

Primary

Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence

Time frame: 12 months after randomization

Population: Out of the 3382 completed follow-up surveys, 3307 completed the primary smoking-abstinence outcome.

ArmMeasureValue (NUMBER)
Usual CareSelf-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence10.9 percentage of participants
Proactive CareSelf-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence13.5 percentage of participants
p-value: 0.02Regression, Logistic
Secondary

7-day Point Prevalence Abstinence

Time frame: 12 months after randomizatoin

Population: Out of the 3382 completed follow-up surveys, 3056 completed the 7-day point prevalence outcome.

ArmMeasureValue (NUMBER)
Usual Care7-day Point Prevalence Abstinence15.1 percentage of participants
Proactive Care7-day Point Prevalence Abstinence17.1 percentage of participants
p-value: 0.13Regression, Logistic
Secondary

Treatment Utilization Rates for Counseling and/or Pharmacotherapy

Time frame: 12 months after randomization

ArmMeasureGroupValue (NUMBER)
Usual CareTreatment Utilization Rates for Counseling and/or PharmacotherapyTelephone counseling2.2 percentage of participants
Usual CareTreatment Utilization Rates for Counseling and/or PharmacotherapyUsed medication39 percentage of participants
Usual CareTreatment Utilization Rates for Counseling and/or PharmacotherapyReceived VA smoking cessation medication29.5 percentage of participants
Usual CareTreatment Utilization Rates for Counseling and/or PharmacotherapyCombination counseling and medication5.1 percentage of participants
Usual CareTreatment Utilization Rates for Counseling and/or PharmacotherapyIn-person counseling6 percentage of participants
Usual CareTreatment Utilization Rates for Counseling and/or PharmacotherapyAttended VA smoking cessation clinic3.4 percentage of participants
Proactive CareTreatment Utilization Rates for Counseling and/or PharmacotherapyReceived VA smoking cessation medication34.5 percentage of participants
Proactive CareTreatment Utilization Rates for Counseling and/or PharmacotherapyAttended VA smoking cessation clinic3.2 percentage of participants
Proactive CareTreatment Utilization Rates for Counseling and/or PharmacotherapyTelephone counseling12.7 percentage of participants
Proactive CareTreatment Utilization Rates for Counseling and/or PharmacotherapyIn-person counseling5.5 percentage of participants
Proactive CareTreatment Utilization Rates for Counseling and/or PharmacotherapyUsed medication41.1 percentage of participants
Proactive CareTreatment Utilization Rates for Counseling and/or PharmacotherapyCombination counseling and medication12.8 percentage of participants
p-value: <0.001Mixed effects logistic regression
p-value: 0.57Mixed effects logistic regression
p-value: 0.15Mixed effects logistic regression
p-value: <0.001Mixed effects logistic regression
p-value: 0.77Mixed effects logistic regression
p-value: 0.002Mixed effects logistic regression

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026