Study on Smoking Cessation and Cost Outcomes in the Duke Smoking Cessation Program
- Conditions
- Nicotine Dependence
- Registration Number
- NCT02845687
- Lead Sponsor
- Duke University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 209
- Age 18 or older
- Being treated at the Duke Smoking Cessation Program
- Fluent in written and spoken English.
N/A
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biochemically confirmed continuous 30-day abstinence from smoking 12 weeks post-Target Quit Day (TQD) 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
- Secondary Outcome Measures
Name Time Method Biochemically confirmed 7-day point prevalence abstinence from smoking 12 weeks post-TQD 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
Smoking reduction 12 months post-TQD Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report
Changes in stress Baseline (pre-quit) to 2 and 12 weeks post-TQD Change in self-reported measures of stress, as measured by Perceived Stress Scale
Changes in anxiety Baseline (pre-quit) to 2 and 12 weeks post-TQD Change in self-reported measures of anxiety, as measured by the GAD-7
cost of medications per abstinent smoker 12 weeks post-TQD Self-report 7-day point prevalence abstinence from smoking 12 month post-TQD 7-day point prevalence abstinence as measured by phone-based, single-item self-report
Changes in relapse predictors Baseline (pre-quit) to 1 day post-TQD, 1 week post-TQD, 6 months post-TQD, and 12 months post-TQD Changes in self-reported measures on repeated non-standardized single-item question on stress, urges, and confidence assessed by phone
Overall cost of treatment in dollars per participant 12 weeks post-TQD cost of medical visits in dollars per abstinent participant 12 weeks post-TQD cost of behavioral intervention per abstinent smoker 12 weeks post-TQD Changes in depression Baseline (pre-quit) to 2 and 12 weeks post-TQD Change in self-reported measures of depression, as measured by the PHQ-2
cost of prescribed medications in dollars 12 weeks post-TQD
Trial Locations
- Locations (1)
Duke Smoking Cessation Program
🇺🇸Durham, North Carolina, United States