Study on Smoking Cessation and Cost Outcomes in the Duke Smoking Cessation Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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Observational Study on Smoking Cessation and Cost Outcomes in the Duke Smoking Cessation Program

Conditions
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Nicotine Dependence

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Being treated at the Duke Smoking Cessation Program Fluent in written and spoken English. Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>All participants are patients within the Quit at Duke Smoking Cessation Program. This is an observational study with no interventions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks post-Target Quit Day (TQD) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 1 week 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 | 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 | 12 month post-TQD | 
| Smoking reduction | Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report | 1 day post-TQD | 
| Smoking reduction | Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report | 1 week post-TQD | 
| Smoking reduction | Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report | 6 months post-TQD | 
| Smoking reduction | Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report | 12 months post-TQD | 
| Changes in stress | Change in self-reported measures of stress, as measured by Perceived Stress Scale | 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 | 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 | 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 | 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 medications per abstinent smoker |  | 12 weeks post-TQD | 
| cost of behavioral intervention per abstinent smoker |  | 12 weeks post-TQD | 
| cost of prescribed medications in dollars |  | 12 weeks post-TQD | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nicotine addiction, cigarette smoking