title: Proactive tobacco treatment and population-level cessation: a pragmatic randomized clinical trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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
  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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00608426.
authors.affiliation: Center for Chronic Disease Outcomes Research, a VA Health Services Research and Development Center of Innovation, Minneapolis VA Health Care System, Minneapolis, Minnesota2Department of Medicine, University of Minnesota Medical School, Minneapolis.
authors.forename: Steven S
authors.initials: SS
authors.lastname: Fu
authors.affiliation: Division of Health Care Policy and Research, Mayo Clinic, Rochester, Minnesota.
authors.forename: Michelle
authors.initials: M
authors.lastname: van Ryn
authors.affiliation: VA New York Harbor Healthcare System, New York5Division of General Internal Medicine, New York University School of Medicine, New York.
authors.forename: Scott E
authors.initials: SE
authors.lastname: Sherman
authors.affiliation: Center for Chronic Disease Outcomes Research, a VA Health Services Research and Development Center of Innovation, Minneapolis VA Health Care System, Minneapolis, Minnesota2Department of Medicine, University of Minnesota Medical School, Minneapolis.
authors.forename: Diana J
authors.initials: DJ
authors.lastname: Burgess
authors.affiliation: Center for Chronic Disease Outcomes Research, a VA Health Services Research and Development Center of Innovation, Minneapolis VA Health Care System, Minneapolis, Minnesota2Department of Medicine, University of Minnesota Medical School, Minneapolis.
authors.forename: Siamak
authors.initials: S
authors.lastname: Noorbaloochi
authors.affiliation: Center for Chronic Disease Outcomes Research, a VA Health Services Research and Development Center of Innovation, Minneapolis VA Health Care System, Minneapolis, Minnesota.
authors.forename: Barbara
authors.initials: B
authors.lastname: Clothier
authors.affiliation: Center for Chronic Disease Outcomes Research, a VA Health Services Research and Development Center of Innovation, Minneapolis VA Health Care System, Minneapolis, Minnesota2Department of Medicine, University of Minnesota Medical School, Minneapolis.
authors.forename: Brent C
authors.initials: BC
authors.lastname: Taylor
authors.affiliation: James A. Haley Veterans Hospital, Tampa, Florida7University of South Florida College of Medicine, Tampa.
authors.forename: Carolyn M
authors.initials: CM
authors.lastname: Schlede
authors.affiliation: G.V. (Sonny) Montgomery VA Medical Center, Jackson, Mississippi.
authors.forename: Randy S
authors.initials: RS
authors.lastname: Burke
authors.affiliation: Department of Medicine, University of Minnesota Medical School, Minneapolis.
authors.forename: Anne M
authors.initials: AM
authors.lastname: Joseph
mesh_terms: D000328:Adult; D000368:Aged; D057286:Electronic Health Records; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D012107:Research Design; D016540:Smoking Cessation / Q000379:methods* / Q000706:statistics & numerical data; D017216:Telemedicine / Q000379:methods / Q000458:organization & administration*; D014029:Tobacco Use Disorder / Q000188:drug therapy / Q000628:therapy*; D016896:Treatment Outcome; D014481:United States; D014493:United States Department of Veterans Affairs; D014728:Veterans