Overview

This trial is active, not recruiting.

Condition tobacco use disorder
Treatments usual care, individual rewards, fixed deposits, competitive deposits (pari-mutuel), collaborative rewards
Sponsor University of Pennsylvania
Collaborator National Institutes of Health (NIH)
Start date February 2012
End date November 2015
Trial size 2185 participants
Trial identifier NCT01526265, 814761, R01CA159932

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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).
usual care
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).
(Experimental)
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.
individual rewards
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.
(Experimental)
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.
fixed deposits
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.
(Experimental)
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.
competitive deposits (pari-mutuel)
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.
(Experimental)
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.
collaborative rewards
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 Outcomes

Measure
Salivary cotinine or anabasine testing (metabolites of nicotine)
time frame: at 6 months following the patient selected target quit date.

Secondary Outcomes

Measure
Salivary cotinine or anabasine testing (metabolites of nicotine)
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.

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Way to Quit - Comparative Efficacy, Acceptance and Effectiveness of Health Incentive Structures
Principal investigator Scott Halpern, MD, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Pennsylvania.