The purpose of this study is to conduct an observational assessment of natural outcomes within the Duke Smoking Cessation Program (DSCP), "Quit at Duke." This assessment will include information regarding abstinence rates, changes in patient emotional state following treatment, and costs of operations. Primarily, this study will assess the financial sustainability and the cost-effectiveness of the program.
The purpose of this study is to conduct an observational assessment of natural outcomes within the DSCP, "Quit at Duke." This is an observational study (n=3000) on patients being treated at the DSCP. No interventions are conducted, and data analyzed is collected in the course of clinical care at clinic visits to the Duke Smoking Cessation Program (DSCP). Phone calls are also conducted to determine response to medications and abstinence status up to 12 months following a quit attempt. Outcomes of variables including: demographic variables, evaluation responses, feasibility data, and abstinence rates will be analyzed using general regression models using an ANOVA-based design. Because no intervention is being conducted, there are no safety concerns related to the study.
Study Type
OBSERVATIONAL
Enrollment
209
Duke Smoking Cessation Program
Durham, North Carolina, United States
Biochemically confirmed continuous 30-day abstinence from smoking
Biochemically confirmed 30-day continuous abstinence. Abstinence is determined by a participant both reporting not smoking in the past 30 days AND a result of \< 7 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent
Time frame: 12 weeks post-Target Quit Day (TQD)
Biochemically confirmed 7-day point prevalence abstinence from smoking
Biochemically confirmed 7-day continuous abstinence. Abstinence is determined by a participant both reporting not smoking in the past 7 days AND a result of \< 7 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent
Time frame: 2 weeks post-TQD
Biochemically confirmed 7-day point prevalence abstinence from smoking
Biochemically confirmed 7-day continuous abstinence. Abstinence is determined by a participant both reporting not smoking in the past 7 days AND a result of \< 7 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent
Time frame: 12 weeks post-TQD
Self-report 7-day point prevalence abstinence from smoking
7-day point prevalence abstinence as measured by phone-based, single-item self-report
Time frame: 1 day post-TQD
Self-report 7-day point prevalence abstinence from smoking
7-day point prevalence abstinence as measured by phone-based, single-item self-report
Time frame: 1 week post-TQD
Self-report 7-day point prevalence abstinence from smoking
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7-day point prevalence abstinence as measured by phone-based, single-item self-report
Time frame: 6 month post-TQD
Self-report 7-day point prevalence abstinence from smoking
7-day point prevalence abstinence as measured by phone-based, single-item self-report
Time frame: 12 month post-TQD
Smoking reduction
Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report
Time frame: 1 day post-TQD
Smoking reduction
Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report
Time frame: 1 week post-TQD
Smoking reduction
Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report
Time frame: 6 months post-TQD
Smoking reduction
Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report
Time frame: 12 months post-TQD
Changes in stress
Change in self-reported measures of stress, as measured by Perceived Stress Scale
Time frame: Baseline (pre-quit) to 2 and 12 weeks post-TQD
Changes in anxiety
Change in self-reported measures of anxiety, as measured by the GAD-7
Time frame: Baseline (pre-quit) to 2 and 12 weeks post-TQD
Changes in depression
Change in self-reported measures of depression, as measured by the PHQ-2
Time frame: Baseline (pre-quit) to 2 and 12 weeks post-TQD
Changes in relapse predictors
Changes in self-reported measures on repeated non-standardized single-item question on stress, urges, and confidence assessed by phone
Time frame: Baseline (pre-quit) to 1 day post-TQD, 1 week post-TQD, 6 months post-TQD, and 12 months post-TQD
Overall cost of treatment in dollars per participant
Time frame: 12 weeks post-TQD
cost of medical visits in dollars per abstinent participant
Time frame: 12 weeks post-TQD
cost of medications per abstinent smoker
Time frame: 12 weeks post-TQD
cost of behavioral intervention per abstinent smoker
Time frame: 12 weeks post-TQD
cost of prescribed medications in dollars
Time frame: 12 weeks post-TQD