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Original Investigation |

Proactive Tobacco Treatment and Population-Level Cessation:  A Pragmatic Randomized Clinical Trial

Steven S. Fu, MD, MSCE1,2; Michelle van Ryn, PhD, MPH3; Scott E. Sherman, MD, MPH4,5; Diana J. Burgess, PhD1,2; Siamak Noorbaloochi, PhD1,2; Barbara Clothier, MS1; Brent C. Taylor, PhD1,2; Carolyn M. Schlede, MD6,7; Randy S. Burke, PhD8; Anne M. Joseph, MD, MPH2
[+] Author Affiliations
1Center for Chronic Disease Outcomes Research, a VA Health Services Research and Development Center of Innovation, Minneapolis VA Health Care System, Minneapolis, Minnesota
2Department of Medicine, University of Minnesota Medical School, Minneapolis
3Division of Health Care Policy and Research, Mayo Clinic, Rochester, Minnesota
4VA New York Harbor Healthcare System, New York
5Division of General Internal Medicine, New York University School of Medicine, New York
6James A. Haley Veterans Hospital, Tampa, Florida
7University of South Florida College of Medicine, Tampa
8G.V. (Sonny) Montgomery VA Medical Center, Jackson, Mississippi
JAMA Intern Med. 2014;174(5):671-677. doi:10.1001/jamainternmed.2014.177.
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Importance  Current tobacco use treatment approaches require smokers to request treatment or depend on the provider to initiate smoking cessation care and are therefore reactive. Most smokers do not receive evidence-based treatments for tobacco use that include both behavioral counseling and pharmacotherapy.

Objective  To assess the effect of a proactive, population-based tobacco cessation care model on use of evidence-based tobacco cessation treatments and on population-level smoking cessation rates (ie, abstinence among all smokers including those who use and do not use treatment) compared with usual care among a diverse population of current smokers.

Design, Setting, and Participants  The Veterans Victory Over Tobacco Study, a pragmatic randomized clinical trial involving a population-based registry of current smokers aged 18 to 80 years. A total of 6400 current smokers, identified using the Department of Veterans Affairs (VA) electronic medical record, were randomized prior to contact to evaluate both the reach and effectiveness of the proactive care intervention.

Interventions  Current smokers were randomized to usual care or proactive care. Proactive care combined (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or in-person). Proactive outreach included mailed invitations followed by telephone outreach to motivate smokers to seek treatment with choice of services.

Main Outcomes and Measures  The primary outcome was 6-month prolonged smoking abstinence at 1 year and was assessed by a follow-up survey among all current smokers regardless of interest in quitting or treatment utilization.

Results  A total of 5123 participants were included in the primary analysis. The follow-up survey response rate was 66%. The population-level, 6-month prolonged smoking abstinence rate at 1 year was 13.5% for proactive care compared with 10.9% for usual care (P = .02). Logistic regression mixed model analysis showed a significant effect of the proactive care intervention on 6-month prolonged abstinence (odds ratio [OR], 1.27 [95% CI, 1.03-1.57]). In analyses accounting for nonresponse using likelihood-based not-missing-at-random models, the effect of proactive care on 6-month prolonged abstinence persisted (OR, 1.33 [95% CI, 1.17-1.51]).

Conclusions and Relevance  Proactive, population-based tobacco cessation care 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.

Trial Registration  clinicaltrials.gov Identifier: NCT00608426

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