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

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

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.

Study Overview

• Status: Terminated
• Conditions: Nicotine Dependence

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.

• Study Type: Observational
• Enrollment (Actual): 209

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Smoking Cessation Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will recruit participants through Quit at Duke, also called the Duke Smoking Cessation Program (DSCP). The DSCP is a growing multi-clinic tobacco use treatment program. The initial clinic site is at Duke Cancer Center, but it is positioned to expand over the next several years to include several other clinic sites within the Duke University Health System (DUHS). There are no exclusion criteria for this study.

Description

Inclusion Criteria:

• Age 18 or older
• Being treated at the Duke Smoking Cessation Program
• Fluent in written and spoken English.

Exclusion Criteria: N/A

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: attendance records	Feasibility as measured by attendance and completion of HIT and MIT assessed by attendance records taken by instructors at individual classes or sessions	up to 12 weeks post-TQD
Feasibility: website usage	Feasibility as measured by website usage, as measured by electronically recorded login and site-based timer will record time accessing the site through each intervention	up to 12 weeks post-TQD
Feasibility: course evaluation	Feasibility as measured by course evaluation	up to 12 weeks post-TQD
Feasibility: demographics	Feasibility as measured by demographics of patients at DSCP	Baseline
Feasibility: Medications Used	Feasibility as measured by medication use	12 weeks post-TQD
Feasibility: Behavioral intervention used	Feasibility as measured by behavioral intervention assignment	12 weeks post-TQD
Feasibility: Attendance at DSCP appointments	Feasibility as measured by attendance at DSCP appointments	12 weeks post-TQD
Feasibility: Referral routes to DSCP	Feasibility as measured by referral routes to DSCP	Baseline
Feasibility: Side effects	Feasibility as measured by side effects, as measured by phone assessment	1 day post-TQD
Feasibility: Side effects	Feasibility as measured by side effects, as measured by phone assessment	1 week post-TQD
Feasibility: Side effects	Feasibility as measured by side effects, as measured by phone assessment	6 months post-TQD
Feasibility: Side effects	Feasibility as measured by side effects, as measured by phone assessment	12 months post-TQD
Feasibility: medication adherence	Feasibility as measured by medication adherence, as measured by phone assessment	1 day post-TQD
Feasibility: medication adherence	Feasibility as measured by medication adherence, as measured by phone assessment	1 week post-TQD
Feasibility: medication adherence	Feasibility as measured by medication adherence, as measured by phone assessment	6 months post-TQD
Feasibility: medication adherence	Feasibility as measured by medication adherence, as measured by phone assessment	12 months post-TQD

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Drug Abuse (NIDA)

Publications and helpful links

General Publications

• Taylor GM, Lindson N, Farley A, Leinberger-Jabari A, Sawyer K, Te Water Naude R, Theodoulou A, King N, Burke C, Aveyard P. Smoking cessation for improving mental health. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD013522. doi: 10.1002/14651858.CD013522.pub2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 16, 2016
• Primary Completion (ACTUAL): May 29, 2018
• Study Completion (ACTUAL): May 29, 2018

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (ESTIMATE): July 27, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2019
• Last Update Submitted That Met QC Criteria: September 12, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: cigarette smoking; nicotine addiction
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: Pro00073920; P50DA027840 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO