title: Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers: study protocol for the Helping HAND 2 randomized controlled trial.
abstract: BACKGROUND
  Smoking cessation interventions for hospitalized smokers are effective in promoting smoking cessation, but only if the tobacco dependence treatment continues after the patient leaves the hospital. Sustaining tobacco dependence treatment after hospital discharge is a challenge for health care systems. Our previous single-site randomized controlled trial demonstrated the effectiveness of an intervention that facilitated the delivery of comprehensive tobacco cessation treatment, including both medication and counseling, after hospital discharge. We subsequently streamlined the intervention model to increase its potential for dissemination. This new model is being tested in a larger multi-site trial with broader eligibility criteria in order to enroll a more representative sample of hospitalized smokers. This paper describes the trial design and contrasts it with the earlier study.
  
  
  METHODS
  A 2-arm, 3-site randomized controlled trial is testing the hypothesis that a multi-component Sustained Care intervention is more effective than Standard Care in helping hospitalized cigarette smokers stop smoking after hospital discharge. The trial enrolls adult daily cigarette smokers who are admitted to 1 of 3 participating hospitals in Massachusetts or Pennsylvania. Participants receive the same smoking cessation intervention in the hospital. They are randomly assigned to receive either Standard Care or Sustained Care after hospital discharge. Participants in the Sustained Care arm receive a free 3-month supply of FDA-approved smoking cessation medication and 5 interactive voice response calls that provide tailored motivational messages, medication refills, and access to a live tobacco treatment counselor. Participants in the Standard Care arm receive a smoking cessation medication recommendation and information about community resources. Outcomes are assessed at 1, 3, and 6 months after discharge. The primary outcome is biochemically-validated tobacco abstinence for the past 7 days at 6-month follow-up. Other outcome measures include self-reported tobacco abstinence measures, use of medication and counseling after discharge, hospital readmissions, and program cost-effectiveness.
  
  
  CONCLUSIONS
  We adapted a proven intervention for hospitalized smokers to enhance its potential for dissemination and are testing it in a multi-site trial. Study enrollment data suggests that the trial achieved the goal of recruiting a broader sample of hospitalized smokers.
  
  
  BACKGROUND
  Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (Helping HAND2) NCT01714323. Registered October 22, 2012.
authors: Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA. zreid@partners.org.|Mongan Institute for Health Policy, Massachusetts General Hospital and Partners HealthCare, Boston, MA, USA. zreid@partners.org.
authors: Zachary Z
authors: ZZ
authors: Reid
authors: Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA. sregan@partners.org.|Division of General Internal Medicine, Medical Service, Massachusetts General Hospital, Boston, MA, USA. sregan@partners.org.|Department of Medicine, Harvard Medical School, Boston, MA, USA. sregan@partners.org.
authors: Susan
authors: S
authors: Regan
authors: Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA. jkelley4@partners.org.|Mongan Institute for Health Policy, Massachusetts General Hospital and Partners HealthCare, Boston, MA, USA. jkelley4@partners.org.
authors: Jennifer H K
authors: JH
authors: Kelley
authors: Department of Psychology, University of Vermont, Burlington, VT, USA. jstreck@uvm.edu.
authors: Joanna M
authors: JM
authors: Streck
authors: School of Social Work, University of Pittsburgh, Pittsburgh, PA, USA. yliojat@upmc.edu.
authors: Thomas
authors: T
authors: Ylioja
authors: Department of Medicine, Vanderbilt Initiatives in Tobacco, Addiction and Lifestyle (VITAL) Center, Vanderbilt University Medical Center, Nashville, TN, USA. hilary.tindle@vanderbilt.edu.
authors: Hilary A
authors: HA
authors: Tindle
authors: Division of General Internal Medicine, Medical Service, Massachusetts General Hospital, Boston, MA, USA. ychang@partners.org.|Department of Medicine, Harvard Medical School, Boston, MA, USA. ychang@partners.org.
authors: Yuchiao
authors: Y
authors: Chang
authors: Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA. dlevy3@partners.org.|Mongan Institute for Health Policy, Massachusetts General Hospital and Partners HealthCare, Boston, MA, USA. dlevy3@partners.org.|Department of Medicine, Harvard Medical School, Boston, MA, USA. dlevy3@partners.org.
authors: Douglas E
authors: DE
authors: Levy
authors: Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA. epark@partners.org.|Mongan Institute for Health Policy, Massachusetts General Hospital and Partners HealthCare, Boston, MA, USA. epark@partners.org.|Department of Psychiatry, Harvard Medical School, Boston, MA, USA. epark@partners.org.
authors: Elyse R
authors: ER
authors: Park
authors: Division of General Internal Medicine, Medical Service, Massachusetts General Hospital, Boston, MA, USA. desinger@partners.org.|Department of Medicine, Harvard Medical School, Boston, MA, USA. desinger@partners.org.
authors: Daniel E
authors: DE
authors: Singer
authors: Alere Wellbeing, Inc., Research Center, Seattle, WA, USA. Kelly.Carpenter@alere.com.
authors: Kelly M
authors: KM
authors: Carpenter
authors: Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA. mreyen@partners.org.|Division of General Internal Medicine, Medical Service, Massachusetts General Hospital, Boston, MA, USA. mreyen@partners.org.
authors: Michele
authors: M
authors: Reyen
authors: Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, USA. nrigotti@partners.org.|Mongan Institute for Health Policy, Massachusetts General Hospital and Partners HealthCare, Boston, MA, USA. nrigotti@partners.org.|Division of General Internal Medicine, Medical Service, Massachusetts General Hospital, Boston, MA, USA. nrigotti@partners.org.|Department of Medicine, Harvard Medical School, Boston, MA, USA. nrigotti@partners.org.
authors: Nancy A
authors: NA
authors: Rigotti
mesh_terms: D000328:Adult; D057186:Comparative Effectiveness Research; D003376:Counseling; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D008404:Massachusetts; D008875:Middle Aged; D009042:Motivation; D017063:Outcome Assessment, Health Care; D010351:Patient Discharge; D010414:Pennsylvania; D012107:Research Design; D016540:Smoking Cessation / Q000379:methods*; D061485:Tobacco Use Cessation Devices; D014029:Tobacco Use Disorder / Q000628:therapy*; D016896:Treatment Outcome