Smoking Cessation, Smoking Tobacco
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame |
|---|---|
| Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence | 12 months after randomization |
Secondary
| Measure | Time frame |
|---|---|
| Treatment Utilization Rates for Counseling and/or Pharmacotherapy | 12 months after randomization |
| 7-day Point Prevalence Abstinence | 12 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
| Arm | Count |
|---|---|
| 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 |
| Total | 5,123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 32 | 36 |
| Overall Study | Lost to Follow-up | 485 | 521 |
| Overall Study | refused, health issues, wrong address | 319 | 348 |
Baseline characteristics
| Characteristic | Usual Care | Proactive Care | Total |
|---|---|---|---|
| Age, Continuous | 56.4 years STANDARD_DEVIATION 10.2 | 55.8 years STANDARD_DEVIATION 15.1 | 56.1 years STANDARD_DEVIATION 14.3 |
| Anxiety Disorder No | 2357 participants | 2230 participants | 4587 participants |
| Anxiety Disorder Yes | 247 participants | 289 participants | 536 participants |
| Depression No | 2039 participants | 1967 participants | 4006 participants |
| Depression Yes | 565 participants | 552 participants | 1117 participants |
| Distance to the VA hospital, miles >10-25 | 698 participants | 662 participants | 1360 participants |
| Distance to the VA hospital, miles >25-50 | 425 participants | 436 participants | 861 participants |
| Distance to the VA hospital, miles <5 | 212 participants | 174 participants | 386 participants |
| Distance to the VA hospital, miles >50 | 797 participants | 791 participants | 1588 participants |
| Distance to the VA hospital, miles 5-10 | 472 participants | 456 participants | 928 participants |
| Married Married | 1156 participants | 1108 participants | 2264 participants |
| Married Not Married | 1448 participants | 1411 participants | 2859 participants |
| Other psychiatric disorder No | 2174 participants | 2103 participants | 4277 participants |
| Other psychiatric disorder Yes | 430 participants | 416 participants | 846 participants |
| Other substance use disorder No | 2070 participants | 2038 participants | 4108 participants |
| Other substance use disorder Yes | 534 participants | 481 participants | 1015 participants |
| Post-traumatic stress disorder No | 2388 participants | 2303 participants | 4691 participants |
| Post-traumatic stress disorder Yes | 216 participants | 216 participants | 432 participants |
| Presence of psychiatric co-morbidity None | 1383 participants | 1335 participants | 2718 participants |
| Presence of psychiatric co-morbidity One | 612 participants | 605 participants | 1217 participants |
| Presence of psychiatric co-morbidity Two or more | 609 participants | 579 participants | 1188 participants |
| Race/Ethnicity, Customized Black | 568 participants | 595 participants | 1163 participants |
| Race/Ethnicity, Customized Hispanic | 120 participants | 111 participants | 231 participants |
| Race/Ethnicity, Customized Other | 203 participants | 210 participants | 413 participants |
| Race/Ethnicity, Customized White | 1713 participants | 1603 participants | 3316 participants |
| Serious mental illness No | 2427 participants | 2358 participants | 4785 participants |
| Serious mental illness Yes | 177 participants | 161 participants | 338 participants |
| Sex: Female, Male Female | 158 Participants | 141 Participants | 299 Participants |
| Sex: Female, Male Male | 2446 Participants | 2378 Participants | 4824 Participants |
| Smoking related cancer Cancer | 57 participants | 71 participants | 128 participants |
| Smoking related cancer No cancer | 2547 participants | 2448 participants | 4995 participants |
| Smoking related cardiovascular disease No | 1901 participants | 1842 participants | 3743 participants |
| Smoking related cardiovascular disease Yes | 703 participants | 677 participants | 1380 participants |
| Smoking related respiratory disease No | 2104 participants | 2061 participants | 4165 participants |
| Smoking related respiratory disease Yes | 500 participants | 458 participants | 958 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2,604 | 0 / 2,519 |
| serious Total, serious adverse events | 0 / 2,604 | 0 / 2,519 |
Outcome results
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence | 10.9 percentage of participants |
| Proactive Care | Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence | 13.5 percentage of participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | 7-day Point Prevalence Abstinence | 15.1 percentage of participants |
| Proactive Care | 7-day Point Prevalence Abstinence | 17.1 percentage of participants |
Treatment Utilization Rates for Counseling and/or Pharmacotherapy
Time frame: 12 months after randomization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Treatment Utilization Rates for Counseling and/or Pharmacotherapy | Telephone counseling | 2.2 percentage of participants |
| Usual Care | Treatment Utilization Rates for Counseling and/or Pharmacotherapy | Used medication | 39 percentage of participants |
| Usual Care | Treatment Utilization Rates for Counseling and/or Pharmacotherapy | Received VA smoking cessation medication | 29.5 percentage of participants |
| Usual Care | Treatment Utilization Rates for Counseling and/or Pharmacotherapy | Combination counseling and medication | 5.1 percentage of participants |
| Usual Care | Treatment Utilization Rates for Counseling and/or Pharmacotherapy | In-person counseling | 6 percentage of participants |
| Usual Care | Treatment Utilization Rates for Counseling and/or Pharmacotherapy | Attended VA smoking cessation clinic | 3.4 percentage of participants |
| Proactive Care | Treatment Utilization Rates for Counseling and/or Pharmacotherapy | Received VA smoking cessation medication | 34.5 percentage of participants |
| Proactive Care | Treatment Utilization Rates for Counseling and/or Pharmacotherapy | Attended VA smoking cessation clinic | 3.2 percentage of participants |
| Proactive Care | Treatment Utilization Rates for Counseling and/or Pharmacotherapy | Telephone counseling | 12.7 percentage of participants |
| Proactive Care | Treatment Utilization Rates for Counseling and/or Pharmacotherapy | In-person counseling | 5.5 percentage of participants |
| Proactive Care | Treatment Utilization Rates for Counseling and/or Pharmacotherapy | Used medication | 41.1 percentage of participants |
| Proactive Care | Treatment Utilization Rates for Counseling and/or Pharmacotherapy | Combination counseling and medication | 12.8 percentage of participants |