Tobacco Use Disorder Clinical Trial
Official title:
Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
Cigarette smoking is the leading preventable cause of death in the U.S. The 2008 US Public
Health Service Smoking Cessation Guideline recommends offering effective treatment to smokers
in all health care settings, including hospitals. Nearly 4 million smokers are hospitalized
each year, and hospital admission offers a "teachable moment" for intervention.
Hospital-initiated smoking cessation intervention is effective, but only if contact continues
for more than 1 month after discharge. The challenge is to translate this research into
clinical practice by identifying an evidence-based cost-effective model that U.S. hospitals
can adopt. The major barrier is sustaining contact after discharge. This project tests an
innovative strategy to streamline the delivery and maximize the uptake of post-discharge
smoking interventions.
Specific Aim: To test the effectiveness of an innovative strategy to maximize smokers' use of
evidence-based tobacco treatment (counseling and medication) after hospital discharge,
thereby increasing the proportion of smokers who achieve long-term (6-month) tobacco
abstinence.
Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll
1350 adult smokers admitted to 3 acute care hospitals in Massachusetts and Pennsylvania. All
subjects will receive a brief in-hospital smoking intervention and be randomly assigned at
discharge to either Standard Care (passive referral to their state quitline) or Extended
Care, a 3-month program consisting of (1) Free Medication: A 30-day supply of FDA-approved
medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and
refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive
Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider. IVR
aims to encourage medication adherence and enhance counseling efficiency by identifying
smokers who need post-discharge support. Immediate transfer of a patient from automated IVR
call to live telephone counselor will facilitate a successful connection to counseling.
Outcomes, assessed at 1, 3, and 6 months after hospital discharge, are: (1) intervention
effectiveness (cotinine-validated 7-day point-prevalence tobacco abstinence rate at 6 month
follow-up [primary outcome] and other tobacco abstinence measures); (2) treatment
utilization, and (3) cost-effectiveness (cost per quit). Exploratory analyses will examine
the intervention's effect on hospital readmissions and mortality in the 6 months after
discharge.
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