Way to Quit - Comparative Efficacy, Acceptance and Effectiveness of Health Incentive Structures

Tobacco Use Disorder Clinical Trial

Official title:

Way to Quit - Comparative Efficacy, Acceptance and Effectiveness of Health Incentive Structures

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01526265
• Other study ID #: 814761
• Secondary ID: R01CA159932
• Status: Active, not recruiting
• Phase: N/A
• First received: January 31, 2012
• Last updated: December 2, 2014
• Start date: February 2012
• Est. completion date: November 2015

Study information

• Verified date: December 2014
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2185
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Behavioral:
• 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).
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

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* Note: There are 71 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 6 months following the patient selected target quit date.	No
Secondary	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.	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.	No