title: Nicotine patches and quitline counseling to help hospitalized smokers stay quit: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Hospitalized smokers often quit smoking, voluntarily or involuntarily; most relapse soon after discharge. Extended follow-up counseling can help prevent relapse. However, it is difficult for hospitals to provide follow-up and smokers rarely leave the hospital with quitting aids (for example, nicotine patches). This study aims to test a practical model in which hospitals work with a state cessation quitline. Hospital staff briefly intervene with smokers at bedside and refer them to the quitline. Depending on assigned condition, smokers may receive nicotine patches at discharge or extended quitline telephone counseling post-discharge. This project establishes a practical model that lends itself to broader dissemination, while testing the effectiveness of the interventions in a rigorous randomized trial.
  
  
  METHODS
  This randomized clinical trial (N = 1,640) tests the effect of two interventions on long-term quit rates of hospitalized smokers in a 2 x 2 factorial design. The interventions are (1) nicotine patches (eight-week, step down program) dispensed at discharge and (2) proactive telephone counseling provided by the state quitline after discharge. Subjects are randomly assigned into: usual care, nicotine patches, telephone counseling, or both patches and counseling. It is hypothesized that patches and counseling have independent effects and their combined effect is greater than either alone. The primary outcome measure is thirty-day abstinence at six months; a secondary outcome is biochemically validated smoking status. Cost-effectiveness analysis is conducted to compare each intervention condition (patch alone, counseling alone, and combined interventions) against the usual care condition. Further, this study examines whether smokers' medical diagnosis is a moderator of treatment effect. Generalized linear (binomial) mixed models will be used to study the effect of treatment on abstinence rates. Clustering is accounted for with hospital-specific random effects.
  
  
  CONCLUSIONS
  If this model is effective, quitlines across the U.S. could work with interested hospitals to set up similar systems. Hospital accreditation standards related to tobacco cessation performance measures require follow-up after discharge and provide additional incentive for hospitals to work with quitlines. The ubiquity of quitlines, combined with the consistency of quitline counseling delivery as centralized state operations, make this partnership attractive.
  
  
  BACKGROUND
  Smoking cessation in hospitalized smokers NCT01289275. Date of registration February 1, 2011; date of first patient August 3, 2011.
authors.affiliation: Department of Family and Preventive Medicine, University of California, La Jolla, San Diego, CA 92093-0905, USA.
authors.forename: Sharon
authors.initials: S
authors.lastname: Cummins
authors.forename: Shu-Hong
authors.initials: SH
authors.lastname: Zhu
authors.forename: Anthony
authors.initials: A
authors.lastname: Gamst
authors.forename: Carrie
authors.initials: C
authors.lastname: Kirby
authors.forename: Kendra
authors.initials: K
authors.lastname: Brandstein
authors.forename: Hillary
authors.initials: H
authors.lastname: Klonoff-Cohen
authors.forename: Edward
authors.initials: E
authors.lastname: Chaplin
authors.forename: Timothy
authors.initials: T
authors.lastname: Morris
authors.forename: Gregory
authors.initials: G
authors.lastname: Seymann
authors.forename: Joshua
authors.initials: J
authors.lastname: Lee
mesh_terms: D000279:Administration, Cutaneous; D000359:Aftercare; D002140:California; D003362:Cost-Benefit Analysis; D003376:Counseling / Q000191:economics; D016527:Drug Costs; D017721:Hospital Costs; D015277:Hotlines / Q000191:economics; D006801:Humans; D007297:Inpatients; D009538:Nicotine / Q000008:administration & dosage* / Q000191:economics; D018722:Nicotinic Agonists / Q000008:administration & dosage* / Q000191:economics; D010351:Patient Discharge; D012008:Recurrence; D012107:Research Design; D012907:Smoking / Q000191:economics / Q000523:psychology; D016540:Smoking Cessation / Q000191:economics / Q000379:methods*; D000074606:Smoking Prevention; D013689:Telephone; D013997:Time Factors; D061485:Tobacco Use Cessation Devices / Q000191:economics; D057968:Transdermal Patch; D016896:Treatment Outcome
chemical_list: D018722:Nicotinic Agonists; D009538:Nicotine