title: Health and economic effects from linking bedside and outpatient tobacco cessation services for hospitalized smokers in two large hospitals: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Extended smoking cessation follow-up after hospital discharge significantly increases abstinence. Hospital smoke-free policies create a period of 'forced abstinence' for smokers, thus providing an opportunity to integrate tobacco dependence treatment, and to support post-discharge maintenance of hospital-acquired abstinence. This study is funded by the National Heart, Lung, and Blood Institute (1U01HL1053231).
  
  
  METHODS
  The Inpatient Technology-Supported Assisted Referral study is a multi-center, randomized clinical effectiveness trial being conducted at Kaiser Permanente Northwest (KPNW) and at Oregon Health & Science University (OHSU) hospitals in Portland, Oregon. The study assesses the effectiveness and cost-effectiveness of linking a practical inpatient assisted referral to outpatient cessation services plus interactive voice recognition (AR + IVR) follow-up calls, compared to usual care inpatient counseling (UC). In November 2011, we began recruiting 900 hospital patients age ≥18 years who smoked ≥1 cigarettes in the past 30 days, willing to remain abstinent postdischarge, have a working phone, live within 50 miles of the hospital, speak English, and have no health-related barriers to participation. Each site will randomize 450 patients to AR + IVR or UC using a 2:1 assignment strategy. Participants in the AR + IVR arm will receive a brief inpatient cessation consult plus a referral to available outpatient cessation programs and medications, and four IVR follow-up calls over seven weeks postdischarge. Participants do not have to accept the referral. At KPNW, UC participants will receive brief inpatient counseling and encouragement to self-enroll in available outpatient services. The primary outcome is self-reported thirty-day smoking abstinence at six months postrandomization for AR + IVR participants compared to usual care. Additional outcomes include self-reported and biochemically confirmed seven-day abstinence at six months, self-reported seven-day, thirty-day, and continuous abstinence at twelve months, intervention dose response at six and twelve months for AR + IVR recipients, incremental cost-effectiveness of AR + IVR intervention compared to usual care at six and twelve months, and health-care utilization and expenditures at twelve months for AR + IVR recipients compared to UC.
  
  
  CONCLUSIONS
  This study will provide important evidence for the effectiveness and cost-effectiveness of linking hospital-based tobacco treatment specialists' services with discharge follow-up care.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01236079.
authors.affiliation: Kaiser Permanente Center for Health Research, 3800 N Interstate Avenue, Portland, OR 97227, USA. jeffrey.fellows@kpchr.org
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Fellows
authors.forename: Richard
authors.initials: R
authors.lastname: Mularski
authors.forename: Lisa
authors.initials: L
authors.lastname: Waiwaiole
authors.forename: Kim
authors.initials: K
authors.lastname: Funkhouser
authors.forename: Julie
authors.initials: J
authors.lastname: Mitchell
authors.forename: Kathleen
authors.initials: K
authors.lastname: Arnold
authors.forename: Sabrina
authors.initials: S
authors.lastname: Luke
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000553:Ambulatory Care / Q000191:economics*; D003266:Continuity of Patient Care / Q000191:economics*; D017046:Cost Savings; D003362:Cost-Benefit Analysis; D003376:Counseling / Q000191:economics; D005260:Female; D017048:Health Care Costs; D006785:Hospitals, University / Q000191:economics; D006801:Humans; D007297:Inpatients; D008297:Male; D008875:Middle Aged; D009922:Oregon; D010351:Patient Discharge; D012017:Referral and Consultation / Q000191:economics; D012107:Research Design; D012907:Smoking / Q000009:adverse effects / Q000191:economics*; D016540:Smoking Cessation / Q000191:economics*; D000074606:Smoking Prevention; D013689:Telephone / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult