TY - JOUR
T1 - Health and economic effects from linking bedside and outpatient tobacco cessation services for hospitalized smokers in two large hospitals
T2 - study protocol for a randomized controlled trial
AU - Fellows, Jeffrey L.
AU - Mularski, Richard
AU - Waiwaiole, Lisa
AU - Funkhouser, Kim
AU - Mitchell, Julie
AU - Arnold, Kathleen
AU - Luke, Sabrina
N1 - Funding Information:
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).
Funding Information:
This is a multicenter, randomized usual care-controlled clinical effectiveness trial conducted with patients admitted to two large hospitals serving the Portland, Oregon and southwest Washington metropolitan area. We will randomize 900 participants to receive either an inpatient assisted referral for postdischarge tobacco-cessation services plus interactive voice recognition support (AR + IVR) or usual care (UC). This study is one of six studies funded by the National Institutes of Health (NIH) that make up the Consortium of Hospitals Advancing Research on Tobacco (CHART). The study was approved by the Institutional Review Board (IRB) of each participating institution, and all participants provide written informed consent. The CHART Data Safety Monitoring Board (DSMB) also reviewed and approved the study.
Funding Information:
This study was conducted within the Consortium of Hospitals to Advance Research on Tobacco (CHART), an affiliation of tobacco control researchers from six non-profit research organizations and the National Institutes of Health with the aims of evaluating the effectiveness and cost-effectiveness of practical interventions to reduce smoking among hospitalized patients. CHART is funded by the National Heart, Lung, and Blood Institute (HL105218, HL105229, HL105231, HL105232, HL105233), National Cancer Institute (CA159533), and the National Institute on Drug Abuse (DA031515). We would like to thank Dr. Christina Gullion for her thoughtful statistical guidance during the study design and implementation stages.
PY - 2012/8/1
Y1 - 2012/8/1
N2 - 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.
AB - 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.
KW - Assisted referral to outpatient services
KW - Cost-effectiveness analysis
KW - Hospitalized smokers
KW - Randomized clinical trial
KW - Smoking cessation
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U2 - 10.1186/1745-6215-13-129
DO - 10.1186/1745-6215-13-129
M3 - Article
C2 - 22853325
AN - SCOPUS:84864399911
SN - 1745-6215
VL - 13
JO - Trials
JF - Trials
M1 - 129
ER -