Cigarette Smoking Clinical Trial
Official title:
Smoking Interventions for Hospital Patients: A Comparative Effectiveness Trial
Cigarette smoking is the leading preventable cause of death in the U.S. Nearly 4 million
U.S. smokers are hospitalized each year, many of them at high risk for tobacco-related
disease or death. A hospital admission provides an opportunity for a smoker to quit. Smoking
cessation counseling provided in the hospital is effective, but only if it continues for >1
month after discharge. Smoking cessation medications add benefit to counseling but are not
often used. The challenge is to translate this efficacy research into routine clinical
practice. The major barrier is to make the transition from inpatient to outpatient care. An
evidence-based, cost-effective intervention model that can be adopted by U.S. hospitals is
needed to realize the potential impact of hospital smoking interventions.
The Specific Aim of this project is to conduct a randomized controlled comparative
effectiveness trial of two strategies to promote smoking cessation in hospitalized patients:
(1) a hospital-only intervention that meets the current standard of the National Hospital
Quality Measures("Standard Care"), and (2) an "Extended Care Management" model with 2
components that aims to encourage and facilitate the sustained use of smoking cessation
treatment (counseling and medication use) after discharge in order to achieve long-term
abstinence. It adds to Standard Care 3 months of telephone-based contact after discharge and
feature 2 innovations: (1) to increase medication use, smokers willing to make a quit
attempt receive a free, refillable 30-day sample of their choice of FDA-approved smoking
cessation medication at hospital discharge; (2) to increase counseling cost-effectiveness,
interactive voice recognition (IVR) technology is used to make automated telephone calls to
identify the smokers interested in or most likely to benefit from continued counseling after
discharge. The trial will enroll 330 adult smokers admitted to Massachusetts General
Hospital, a 900-bed teaching hospital. Outcomes will be measured 1,3 and 6 months after
hospital discharge. Study hypotheses are that the enhanced care arm, compared to usual care,
is feasible and will increase (1) the use of smoking cessation treatment after discharge,
(2) the duration of post-discharge tobacco abstinence, and (3) validated tobacco abstinence
6 months after hospital discharge (primary outcome). The principal secondary outcome measure
is self-reported 7-day point prevalence tobacco abstinence after hospital discharge. Other
secondary endpoints include self-reported point prevalence abstinence at 1 and 3 months,
prolonged abstinence (self-reported tobacco abstinence at 1, 3, and 6 months). The
cost-effectiveness (cost per quit) of the interventions will be also be compared.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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