Back to resultsWay to Quit - Comparative Efficacy, Acceptance and Effectiveness of Health Incentive Structures
Primary Purpose
Tobacco Use Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care
Individual Rewards
Fixed Deposits
Competitive Deposits (Pari-Mutuel)
Collaborative Rewards
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Smoking Cessation, Work-site, Incentives, Health Behavior, Smoking
Eligibility Criteria
Inclusion Criteria:
- Active smoker of 5 cigarettes per day for at least 6 months;
- At least 18 years old;
- Current full- or part-time employee of CVS or be a family member or friend of a current full- or part-time employee of CVS.
Exclusion Criteria:
- Use a form of tobacco other than cigarettes while participating in the study (as this may influence biochemical testing);
- Are unable or unwilling to access the internet;
- Are unable to provide informed consent.
- Due to the web-based nature of this study, people without reliable computer and internet access will also be excluded.
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Usual Care
Individual Rewards
Fixed Deposits
Competitive Deposits (Pari-Mutuel)
Collaborative Rewards
Arm Description
Participants will be offered free smoking cessation programs, and be provided web-based education regarding the health and economic benefits of smoking cessation. Participants will also have the opportunity to submit weekly reports on their smoking habits. They will be informed that they will receive reimbursements for completing the surveys that are part of the Way To Quit program and for submitting saliva or urine samples at 14 days, 30 days, 6 months, and 12 months (among those eligible).
Same as USUAL CARE arm, plus financial incentive as follows: if participants quit smoking by their target quit date, and that is confirmed by cotinine or anabasine tests, they will receive a monetary award from the study investigators.
Same as USUAL CARE arm, plus financial incentive as follows: participants will have to deposit a certain monetary amount of their own money as an incentive to quit smoking. If they quit smoking by their target quit date, and that is confirmed by cotinine or anabasine tests, participants will receive their deposit back. If participants do not quit, their money will be used to support future research studies designed to help people stop smoking. As a motivation to quit smoking, the participant's deposit will be matched by the study investigators in a rate of 3:1.
Same as USUAL CARE, plus financial incentive as follows: groups (or "cohorts") of 6 smokers each will be formed on a rolling basis, linking individuals with target quit dates (day "0's") near each other. Participants will deposit a certain monetary amount (Y) in an account, which will be matched on a rate of 3:1 by the study investigators (M), and the payout for quitting on this arm will be (Y+M) x 6/Q , where Q is the number of quits in the cohort. Again, success will be confirmed by cotinine or anabasine tests, and if participants do not quit, their money will be used to support future research studies designed to help people stop smoking.
Same as USUAL CARE arm, plus financial incentive as follows: groups (or "cohorts") of 6 smokers each will be formed on a rolling basis, linking individuals with target quit dates (day "0's") near each other. If participants quit smoking by their target quit date, and that is confirmed by cotinine or anabasine tests, they will receive a monetary award from the study investigators. On top of that, participants will receive an additional monetary amount for each member of their group who also quits smoking. These participants will interact through a chat room, which will help motivate them to quit smoking.
Outcomes
Primary Outcome Measures
Salivary cotinine or anabasine testing (metabolites of nicotine)
The primary measure of smoking cessation will be prolonged abstinence for 6 months, which will be measured by salivary cotinine testing or by urinary anabasine testing (for those participants using nicotine replacement therapy). Saliva samples will be analyzed using semi-quantitative immunochromatographic assay test strips at the University of Pennsylvania. Urine samples will be analyzed using gas chromatography at the Associated Regional and University Pathologists (ARUP) Lab, at the University of Utah.
Secondary Outcome Measures
Salivary cotinine or anabasine testing (metabolites of nicotine)
Another secondary outcome variable will be the proportion of participants achieving point prevalence abstinence at 14 days, 30 days, 6 months and 12 months after the quit date.
Full Information
NCT ID
NCT01526265
First Posted
January 31, 2012
Last Updated
May 10, 2016
Sponsor
University of Pennsylvania
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01526265
Brief Title
Way to Quit - Comparative Efficacy, Acceptance and Effectiveness of Health Incentive Structures
Official Title
Way to Quit - Comparative Efficacy, Acceptance and Effectiveness of Health Incentive Structures
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Using the NIH-funded Way to Health platform, the investigators will conduct this smoking cessation randomized controlled trial (RCT) among CVS employees. The investigators will be able to determine the comparative and absolute efficacy and effectiveness of 4 different incentive structures that are each grounded in behavioral economic principles. Additionally, the investigators will measure rates of and reasons for acceptance of each incentive structure, and examine participant characteristics that modify the efficacy and acceptance of different incentive structures.
Detailed Description
Specific Aim I: Compare the efficacy and effectiveness of 4 financial incentive structures for improving "quit rates" (rates of prolonged smoking abstinence for 6 months): (a) individual financial rewards, (b) individual deposit contracts, (c) cooperative rewards, and (d) competitive deposit contracts
H1: Compared with usual care, all 4 incentive structures will increase quit rates significantly.
H2: Compared with individual financial rewards of equivalent size and schedule, individual deposit contracts, cooperative rewards, and competitive contracts will each increase quit rates significantly.
H3: Group-oriented structures will increase quit rates significantly more than individual-oriented structures.
Specific Aim II: Compare smokers' acceptance of these 4 financial incentive structures for smoking cessation
H4: Uptake rates of reward-based structures will be higher than of structures involving deposit contracts.
H5: Uptake rates of group-oriented structures will be higher than of individual-oriented structures.
Specific Aim III: Identify individual characteristics that modify incentive structures' efficacy and acceptance
H6: Incentives will promote relatively greater quit rates among participants with fewer substitute reinforcers.
H7: Incentives will promote relatively greater quit rates among participants with lower incomes.
H8: Higher-income persons will be relatively more likely to accept incentives requiring deposit contracts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Smoking Cessation, Work-site, Incentives, Health Behavior, Smoking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2185 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants will be offered free smoking cessation programs, and be provided web-based education regarding the health and economic benefits of smoking cessation. Participants will also have the opportunity to submit weekly reports on their smoking habits. They will be informed that they will receive reimbursements for completing the surveys that are part of the Way To Quit program and for submitting saliva or urine samples at 14 days, 30 days, 6 months, and 12 months (among those eligible).
Arm Title
Individual Rewards
Arm Type
Experimental
Arm Description
Same as USUAL CARE arm, plus financial incentive as follows: if participants quit smoking by their target quit date, and that is confirmed by cotinine or anabasine tests, they will receive a monetary award from the study investigators.
Arm Title
Fixed Deposits
Arm Type
Experimental
Arm Description
Same as USUAL CARE arm, plus financial incentive as follows: participants will have to deposit a certain monetary amount of their own money as an incentive to quit smoking. If they quit smoking by their target quit date, and that is confirmed by cotinine or anabasine tests, participants will receive their deposit back. If participants do not quit, their money will be used to support future research studies designed to help people stop smoking. As a motivation to quit smoking, the participant's deposit will be matched by the study investigators in a rate of 3:1.
Arm Title
Competitive Deposits (Pari-Mutuel)
Arm Type
Experimental
Arm Description
Same as USUAL CARE, plus financial incentive as follows: groups (or "cohorts") of 6 smokers each will be formed on a rolling basis, linking individuals with target quit dates (day "0's") near each other. Participants will deposit a certain monetary amount (Y) in an account, which will be matched on a rate of 3:1 by the study investigators (M), and the payout for quitting on this arm will be (Y+M) x 6/Q , where Q is the number of quits in the cohort. Again, success will be confirmed by cotinine or anabasine tests, and if participants do not quit, their money will be used to support future research studies designed to help people stop smoking.
Arm Title
Collaborative Rewards
Arm Type
Experimental
Arm Description
Same as USUAL CARE arm, plus financial incentive as follows: groups (or "cohorts") of 6 smokers each will be formed on a rolling basis, linking individuals with target quit dates (day "0's") near each other. If participants quit smoking by their target quit date, and that is confirmed by cotinine or anabasine tests, they will receive a monetary award from the study investigators. On top of that, participants will receive an additional monetary amount for each member of their group who also quits smoking. These participants will interact through a chat room, which will help motivate them to quit smoking.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Participants will receive reimbursements for completing the surveys that are part of the Way To Quit program and for submitting saliva or urine samples at 14 days, 30 days, 6 months, and 12 months (among those eligible).
Intervention Type
Behavioral
Intervention Name(s)
Individual Rewards
Intervention Description
If participants quit smoking by their target quit date, and that is confirmed by cotinine/anabasine tests, they will receive a monetary award from the study investigators.
Intervention Type
Behavioral
Intervention Name(s)
Fixed Deposits
Intervention Description
Participants will have to deposit a certain monetary amount of their own money as an incentive to quit smoking. If they quit smoking by their target quit date, and that is confirmed by cotinine/anabasine tests, participants will receive their deposit back. If participants do not quit, their money will be used to support future research studies designed to help people stop smoking. As a motivation to quit smoking, the participant's deposit will be matched by the study investigators in a rate of 3:1.
Intervention Type
Behavioral
Intervention Name(s)
Competitive Deposits (Pari-Mutuel)
Intervention Description
Groups (or "cohorts") of 6 smokers each will be formed on a rolling basis, linking individuals with target quit dates (day "0's") near each other. Participants will deposit a certain monetary amount (Y) in an account, which will be matched on a rate of 3:1 by the study investigators (M), and the payout for quitting on this arm will be (Y+M) x 6/Q , where Q is the number of quits in the cohort. Again, success will be confirmed by cotinine or anabasine tests, and if participants do not quit, their money will be used to support future research studies designed to help people stop smoking.
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Rewards
Intervention Description
Groups (or "cohorts") of 6 smokers each will be formed on a rolling basis, linking individuals with target quit dates (day "0's") near each other. If participants quit smoking by their target quit date, and that is confirmed by cotinine or anabasine tests, they will receive a monetary award from the study investigators. On top of that, participants will receive an additional monetary amount for each member of their group who also quits smoking. These participants will interact through a chat room, which will help motivate them to quit smoking.
Primary Outcome Measure Information:
Title
Salivary cotinine or anabasine testing (metabolites of nicotine)
Description
The primary measure of smoking cessation will be prolonged abstinence for 6 months, which will be measured by salivary cotinine testing or by urinary anabasine testing (for those participants using nicotine replacement therapy). Saliva samples will be analyzed using semi-quantitative immunochromatographic assay test strips at the University of Pennsylvania. Urine samples will be analyzed using gas chromatography at the Associated Regional and University Pathologists (ARUP) Lab, at the University of Utah.
Time Frame
at 6 months following the patient selected target quit date.
Secondary Outcome Measure Information:
Title
Salivary cotinine or anabasine testing (metabolites of nicotine)
Description
Another secondary outcome variable will be the proportion of participants achieving point prevalence abstinence at 14 days, 30 days, 6 months and 12 months after the quit date.
Time Frame
at 14 and 30 days, and 6 months following the patient selected target quit date and relapse rate 12 months after the target quit date.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Active smoker of 5 cigarettes per day for at least 6 months;
At least 18 years old;
Current full- or part-time employee of CVS or be a family member or friend of a current full- or part-time employee of CVS.
Exclusion Criteria:
Use a form of tobacco other than cigarettes while participating in the study (as this may influence biochemical testing);
Are unable or unwilling to access the internet;
Are unable to provide informed consent.
Due to the web-based nature of this study, people without reliable computer and internet access will also be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Halpern, MD, Ph.D.
Organizational Affiliation
University of Pennsylvania, Department of Medicine, Pulmonary, Allergy and Critical Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Volpp, MD, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benjamin French, MS, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dylan Small, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Asch, MD, MBA
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janet Audrain-McGovern, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Way to Quit - Comparative Efficacy, Acceptance and Effectiveness of Health Incentive Structures
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