title: A randomised controlled trial to prevent smoking relapse among recently quit smokers enrolled in employer and health plan sponsored quitlines.
abstract: OBJECTIVE
  To test adding an interactive voice response (IVR)-supported protocol to standard quitline treatment to prevent relapse among recently quit smokers.
  
  
  METHODS
  Parallel randomised controlled trial with three arms: standard quitline, standard plus technology enhanced quitline with 10 risk assessments (TEQ-10), standard plus 20 TEQ assessments (TEQ-20).
  
  
  METHODS
  Quit For Life (QFL) programme.
  
  
  METHODS
  1785 QFL enrolees through 19 employers or health plans who were 24+ h quit.
  
  
  METHODS
  QFL is a 5-call telephone-based cessation programme including medications and web-based support. TEQ interventions included 10 or 20 IVR-delivered relapse risk assessments over 8 weeks with automated transfer to counselling for those at risk.
  
  
  METHODS
  Self-reported 7-day and 30-day abstinence assessed at 6-month and 12-month post-enrolment (response rates: 61% and 59%, respectively). Missing data were imputed.
  
  
  RESULTS
  1785 were randomised (standard n=592, TEQ-10 n=602, TEQ-20 n=591). Multiple imputation-derived, intent-to-treat 30-day quit rates (95% CI) at 6 months were 59.4% (53.7% to 63.8%) for standard, 62.3% (57.7% to 66.9%) for TEQ-10, 59.4% (53.7% to 65.1%) for TEQ-20 and 30-day quit rates at 12 months were 61.2% (55.6% to 66.8%) for standard, 60.6% (56.0% to 65.2%) for TEQ-10, 54.9% (49.0% to 60.9%) for TEQ-20. There were no significant differences in quit rates. 73.3% of TEQ participants were identified as at-risk by IVR assessments; on average, participants completed 0.41 IVR-transferred counselling calls. Positive risk assessments identified participants less likely (OR=0.56, 95% CI 0.42 to 0.76) to be abstinent at 6 months.
  
  
  CONCLUSIONS
  Standard treatment was highly effective, with 61% remaining abstinent at 12 months using multiple imputation intent-to-treat (intent-to-treat missing=smoking quit rate: 38%). TEQ assessments identified quitters at risk for relapse. However, adding IVR-transferred counselling did not yield higher quit rates. Research is needed to determine if alternative designs can improve outcomes.
  
  
  BACKGROUND
  NCT00888992.
authors.affiliation: College of Nursing, University of Florida, Gainesville, Florida, USA.
authors.forename: Anna M
authors.initials: AM
authors.lastname: McDaniel
authors.affiliation: Alere Wellbeing, Seattle, Washington, USA.
authors.forename: Katrina A
authors.identifier: http://orcid.org/0000-0003-3642-5265
authors.initials: KA
authors.lastname: Vickerman
authors.affiliation: Department of Biostatistics, Indiana University, School of Medicine, Indianapolis, Indiana, USA.
authors.forename: Timothy E
authors.initials: TE
authors.lastname: Stump
authors.affiliation: Department of Biostatistics, Indiana University, School of Medicine, Indianapolis, Indiana, USA.
authors.forename: Patrick O
authors.initials: PO
authors.lastname: Monahan
authors.affiliation: Kaiser Permanente Center for Health Research, Portland, Oregon, USA.
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Fellows
authors.affiliation: College of Nursing, University of Florida, Gainesville, Florida, USA.
authors.forename: Michael T
authors.initials: MT
authors.lastname: Weaver
authors.affiliation: Alcohol and Drug Abuse Institute, University of Washington, Seattle, Washington, USA.
authors.forename: Beatriz H
authors.initials: BH
authors.lastname: Carlini
authors.affiliation: Indiana University School of Nursing, Indianapolis, Indiana, USA.
authors.forename: Victoria L
authors.initials: VL
authors.lastname: Champion
authors.affiliation: Alere Wellbeing, Seattle, Washington, USA.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Zbikowski
mesh_terms: D000328:Adult; D003376:Counseling; D005260:Female; D005500:Follow-Up Studies; D006264:Health Benefit Plans, Employee; D015277:Hotlines; D006801:Humans; D007348:Insurance, Health; D008297:Male; D015397:Program Evaluation / Q000706:statistics & numerical data*; D012008:Recurrence; D012907:Smoking / Q000628:therapy*; D016540:Smoking Cessation / Q000379:methods* / Q000706:statistics & numerical data*; D016896:Treatment Outcome
keywords: IVR; Interactive Voice Response; quitlines; relapse prevention; smoking