Observational Study on Smoking Cessation and Cost Outcomes in the Duke Smoking Cessation Program
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 209
- 试验地点
- 1
- 主要终点
- Biochemically confirmed continuous 30-day abstinence from smoking
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Being treated at the Duke Smoking Cessation Program
- •Fluent in written and spoken English.
排除标准
- 未提供
结局指标
主要结局
Biochemically confirmed continuous 30-day abstinence from smoking
时间窗: 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
次要结局
- Biochemically confirmed 7-day point prevalence abstinence from smoking(12 weeks post-TQD)
- Smoking reduction(12 months post-TQD)
- Changes in stress(Baseline (pre-quit) to 2 and 12 weeks post-TQD)
- Changes in anxiety(Baseline (pre-quit) to 2 and 12 weeks post-TQD)
- cost of medications per abstinent smoker(12 weeks post-TQD)
- Self-report 7-day point prevalence abstinence from smoking(12 month post-TQD)
- 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)
- 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)
- cost of prescribed medications in dollars(12 weeks post-TQD)