Open Access Study protocol

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

Jeffrey L Fellows1*, Richard Mularski1, Lisa Waiwaiole1, Kim Funkhouser1, Julie Mitchell2, Kathleen Arnold1 and Sabrina Luke1

Author Affiliations

1 Kaiser Permanente Center for Health Research, 3800 N Interstate Avenue, Portland, OR 97227, USA

2 Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR, 97239, USA

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Trials 2012, 13:129  doi:10.1186/1745-6215-13-129

Published: 1 August 2012

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/Design

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.

Discussion

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.

Trial Registration

ClinicalTrials.gov: NCT01236079

Keywords:
Smoking cessation; Hospitalized smokers; Assisted referral to outpatient services; Cost-effectiveness analysis; Randomized clinical trial