BACKGROUND/RATIONALE:
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.

OBJECTIVE(S):
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.

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.

FINDINGS/RESULTS:
A) Across the four VA Medical Centers, nearly all Veterans in primary care had their tobacco use status documented in the VA electronic medical record.

B) Current smokers (N=6400, 1600 per site) as identified by the electronic medical record were randomly assigned to proactive care or usual care with an allocation ratio of 1:1 within each site and mailed a baseline survey. The sample was diverse; 28% African American, 62% Caucasian, 4% other race, and 4% unknown race. Seven percent were of Hispanic ethnicity.

C) The baseline survey response rate was 66%. In the year prior to the start of the study, 57% had made a quit attempt, 1.7% had used telephone smoking cessation counseling, 11% had received in-person smoking cessation counseling and 37% had used smoking cessation medications.

D) In the proactive care intervention group, 2519 were mailed outreach invitation materials. During telephone outreach, 1556 (62%) were successfully contacted. Of the participants mailed an outreach invitation packet, 392 (16%) elected VA telephone coaching and 77 (3%) elected in-person smoking cessation services at their VA Medical Center.

E) The follow-up survey response rate was 67%. During the one year intervention period, current smokers in the proactive care group (57%) were more likely to make at least one quit attempt compared to usual care (53%, p=0.035). In addition, proactive care participants were significantly more likely to use telephone smoking cessation counseling than usual care participants (13.0% versus 1.9%, p<0.001). Proactive care participants were also more likely to have used smoking cessation medications (37.2% proactive care and 32.8% usual care, p=0.010). There were no significant differences in use of in-person smoking cessation counseling between the two groups, 6.3% proactive care and 5.7% usual care.

F) We observed a significant increase in the population-level cessation rate of 2.6%. The population-level cessation rate at one year was 13.4% for proactive care compared to 10.8% for usual care (p=0.025). In generalized linear mixed model analysis, proactive care resulted in increased odds of population-level cessation, OR=1.274 (1.033, 1.571). Additional analyses incorporating multiple imputation methods to estimate missing outcome and independent covariate measures, which adjusted for baseline group differences in age of smoking initiation, and length of prior quit attempts, found that the effect of proactive care on population-level cessation persisted, OR=1.220 (1.002, 1.484).

IMPACT:
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 capitalizes on the availability of validated telephone care protocols to efficiently deliver intensive behavioral counseling and facilitate access to pharmacotherapy. For vulnerable priority populations including racial/ethnic minorities and Veterans, telephone-based smoking cessation services are acceptable and effective for increasing engagement in evidence-based smoking cessation treatments. Moreover, population-based proactive tobacco treatment using proactive outreach to connect smokers to evidence-based telephone or in-person smoking cessation services is effective for increasing long-term population-level cessation rates.

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External Links for this Project

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PUBLICATIONS:

Journal Articles

1. Melzer AC, Clothier BA, Japuntich SJ, Noorbaloochi S, Hammett P, Burgess DJ, Joseph AM, Fu SS. Comparative Effectiveness of Proactive Tobacco Treatment among Smokers with and without Chronic Lower Respiratory Disease. Annals of the American Thoracic Society. 2018 Mar 1; 15(3):341-347. [view]
2. 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. Journal of general internal medicine. 2016 Aug 1; 31(8):878-87. [view]
3. Japuntich SJ, Hammett PJ, Rogers ES, Fu S, Burgess DJ, El Shahawy O, Melzer AC, Noorbaloochi S, Krebs P, Sherman SE. Effectiveness of Proactive Tobacco Cessation Treatment Outreach Among Smokers With Serious Mental Illness. Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco. 2020 Aug 24; 22(9):1433-1438. [view]
4. 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(1):159. [view]
5. 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 internal medicine. 2014 May 1; 174(5):671-7. [view]
6. 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. Addictive Behaviors. 2018 Jan 1; 76:15-19. [view]
7. Hammett PJ, Japuntich SJ, Sherman SE, Rogers ES, Danan ER, Noorbaloochi S, El-Shahawy O, Burgess DJ, Fu SS. Proactive tobacco treatment for veterans with posttraumatic stress disorder. Psychological trauma : theory, research, practice and policy. 2021 Jan 1; 13(1):114-122. [view]
8. 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. American journal of public health. 2014 Sep 1; 104 Suppl 4:S580-7. [view]
9. 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. Women's health issues : official publication of the Jacobs Institute of Women's Health. 2019 Jun 25; 29 Suppl 1:S15-S23. [view]
10. 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. American journal of preventive medicine. 2018 Oct 1; 55(4):506-516. [view]
11. 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 medical research methodology. 2018 May 11; 18(1):39. [view]

Journal Other

1. Joseph A, Fu S. Proactive outreach strategies to connect smokers with tobacco cessation treatment. JAMA internal medicine. 2015 Feb 1; 175(2):226-7. [view]

Conference Presentations

1. Fu SS, Danan ER, Clothier BC, Sherman SS, Burgess DB, Noorbaloochi SN, Joseph AJ. Engagement in Smoking Cessation Treatments and Quit Rates among Smokers with Lower Motivation to Quit. Presented at: Society for Research on Nicotine and Tobacco / Society for Research Nicotine and Tobacco - Europe Joint Conference; 2015 Sep 12; Maastricht, Netherlands. [view]
2. Fu SS. Engaging American Indians and Alaska Natives in Tobacco Control Research. Presented at: Society for Research on Nicotine and Tobacco Annual Conference; 2013 Mar 14; Boston, MA. [view]
3. Fu SS. Proactive Tobacco Treatment and Population-Level Cessation: A Pragmatic Randomized Controlled Trial. Poster session presented at: Society for Research on Nicotine and Tobacco Annual Conference; 2013 Mar 14; Boston, MA. [view]
4. Fu SS, Burgess DJ, Noorbaloochi S, Taylor BC. Proactive Tobacco Treatment and Population-Level Cessation: a Pragmatic Randomized Controlled Trial. Presented at: Society of General Internal Medicine Annual Meeting; 2013 Apr 26; Denver, CO. [view]
5. Fu SS, Burgess DJ, van Ryn M, Sherman S, Noorbaloochi S, Clothier BA, Sandberg AA, Nugent SM, Robert C, Joseph AM. Using Electronic Health Record Registries to Increase use of Telephone Quitline Services among Vulnerable Priority Populations. Paper presented at: Society of General Internal Medicine Annual Meeting; 2011 May 6; Phoenix, AZ. [view]

DRA: Substance Use Disorders, Health Systems Science, Mental, Cognitive and Behavioral Disorders
DRE: Treatment - Observational, Prevention
Keywords: Smoking, Telemedicine
MeSH Terms: none