Proactive Tobacco Treatment for Veterans

NCT ID: NCT00608426

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2013-12-31

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.

Conditions

Smoking Cessation; Smoking Tobacco

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care

Group who can elect to receive reactive (usual) care for smoking cessation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Proactive Care

Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven S. Fu, MD MSCE

Role: PRINCIPAL_INVESTIGATOR

Minneapolis VA Health Care System, Minneapolis, MN

Locations

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, United States

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS

Jackson, Mississippi, United States

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, United States

Philadelphia VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, United States

Countries

United States

References

Fu SS, van Ryn M, Sherman SE, Burgess DJ, Noorbaloochi S, Clothier B, Joseph AM. Population-based tobacco treatment: study design of a randomized controlled trial. BMC Public Health. 2012 Mar 6;12:159. doi: 10.1186/1471-2458-12-159.

Reference Type: RESULT

PMID: 22394386 (View on PubMed)

Fu SS, van Ryn M, Sherman SE, Burgess DJ, Noorbaloochi S, Clothier B, Taylor BC, Schlede CM, Burke RS, Joseph AM. Proactive tobacco treatment and population-level cessation: a pragmatic randomized clinical trial. JAMA Intern Med. 2014 May;174(5):671-7. doi: 10.1001/jamainternmed.2014.177.

Reference Type: RESULT

PMID: 24615217 (View on PubMed)

Burgess DJ, van Ryn M, Noorbaloochi S, Clothier B, Taylor BC, Sherman S, Joseph AM, Fu SS. Smoking cessation among African American and white smokers in the Veterans Affairs health care system. Am J Public Health. 2014 Sep;104 Suppl 4(Suppl 4):S580-7. doi: 10.2105/AJPH.2014.302023.

Reference Type: RESULT

PMID: 25100424 (View on PubMed)

Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

Reference Type: DERIVED

PMID: 39868569 (View on PubMed)

Danan ER, Sherman SE, Clothier BA, Burgess DJ, Pinsker EA, Joseph AM, Noorbaloochi S, Fu SS. Smoking Cessation among Female and Male Veterans before and after a Randomized Trial of Proactive Outreach. Womens Health Issues. 2019 Jun 25;29 Suppl 1(Suppl 1):S15-S23. doi: 10.1016/j.whi.2019.04.001.

Reference Type: DERIVED

PMID: 31253237 (View on PubMed)

Danan ER, Fu SS, Clothier BA, Noorbaloochi S, Hammett PJ, Widome R, Burgess DJ. The Equity Impact of Proactive Outreach to Smokers: Analysis of a Randomized Trial. Am J Prev Med. 2018 Oct;55(4):506-516. doi: 10.1016/j.amepre.2018.05.023. Epub 2018 Aug 20.

Reference Type: DERIVED

PMID: 30139707 (View on PubMed)

Melzer AC, Pinsker EA, Clothier B, Noorbaloochi S, Burgess DJ, Danan ER, Fu SS. Validating the use of veterans affairs tobacco health factors for assessing change in smoking status: accuracy, availability, and approach. BMC Med Res Methodol. 2018 May 11;18(1):39. doi: 10.1186/s12874-018-0501-2.

Reference Type: DERIVED

PMID: 29751746 (View on PubMed)

Japuntich SJ, Sherman SE, Joseph AM, Clothier B, Noorbaloochi S, Danan E, Burgess D, Rogers E, Fu SS. Proactive tobacco treatment for individuals with and without a mental health diagnosis: Secondary analysis of a pragmatic randomized controlled trial. Addict Behav. 2018 Jan;76:15-19. doi: 10.1016/j.addbeh.2017.07.024. Epub 2017 Jul 15.

Reference Type: DERIVED

PMID: 28735036 (View on PubMed)

Danan ER, Joseph AM, Sherman SE, Burgess DJ, Noorbaloochi S, Clothier B, Japuntich SJ, Taylor BC, Fu SS. Does Motivation Matter? Analysis of a Randomized Trial of Proactive Outreach to VA Smokers. J Gen Intern Med. 2016 Aug;31(8):878-87. doi: 10.1007/s11606-016-3687-1. Epub 2016 Apr 12.

Reference Type: DERIVED

PMID: 27071399 (View on PubMed)

Other Identifiers

IAB 05-303

Identifier Type: -

Identifier Source: org_study_id