Smoking Cessation Clinical Trial
— HH4Official title:
Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
Verified date | May 2022 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized controlled trial will compare the effectiveness of two models of post-discharge tobacco cessation treatment for adult smokers admitted to 3 U.S. hospitals.
Status | Completed |
Enrollment | 1416 |
Est. completion date | November 17, 2020 |
Est. primary completion date | November 17, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years of age or older - Current cigarette smoker (>=1 cigarette in the week before admission and >=1 cigarette/day when smoking at a baseline rate in the month prior to admission) - Admitted to a study hospital - Seen by hospital smoking counselor during inpatient stay - Plans to try to quit smoking after hospital discharge Exclusion Criteria: - Inability to give informed consent or participate in counseling due to serious cognitive or psychiatric disorder (e.g., dementia, psychosis) - Life expectancy <12 months - Medical instability - No reliable telephone access or inability to use telephone - Non-English speaking - Pregnant, breastfeeding, to planning to become pregnant in the next 6 months. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | University of Pittsburgh Medical Center, Vanderbilt University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tobacco Abstinence, Biochemically Confirmed | Participant self-report of no use of any tobacco product (cigarettes, cigars, little cigars, pipes, smokeless tobacco product) in the past 7 days AND either a saliva sample with a cotinine concentration <=10 ng/ml OR breath sample with a carbon monoxide concentration <=9 ppm. | 6 months after hospital discharge | |
Secondary | Tobacco Abstinence, Self-report | Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product). | 1 month after hospital discharge | |
Secondary | Tobacco Abstinence, Self-report | Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product). | 3 months after hospital discharge | |
Secondary | Tobacco Abstinence, Self-report | Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product). | 6 months after hospital discharge | |
Secondary | Engagement in Cessation Treatment | Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at the 1 month post-discharge assessment. | 1 month after hospital discharge | |
Secondary | Engagement in Cessation Treatment | Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at 3 month post-discharge assessment | 3 months after hospital discharge | |
Secondary | Self-reported Continuous Tobacco Abstinence Since Hospital Discharge | Number of participants who self-report having smoked no cigarettes and used no other tobacco products (cigars, little cigars, pipes, smokeless tobacco) since index hospital discharge | 6 months follow-up |
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