Pilot Randomized Control Trial of Financial Incentives for Smoking Cessation

Tobacco Use Disorder Clinical Trial

Official title:

Financial Incentive Structures for Smoking Cessation: A Pilot Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303081
• Other study ID #: 812287
• Secondary ID: RC2AG036592
• Status: Completed
• Phase: N/A
• First received: February 17, 2011
• Last updated: August 1, 2012
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Financial incentives may be more effective than other approaches to smoking cessation, but research is needed to identify the optimal structures of incentives. The investigators will conduct a pilot randomized trial comparing different incentive structures for smoking cessation. Collaborating with Walgreens leadership, the investigators will enroll their employees in this RCT using the investigators new web-based research infrastructure (called the Way to Health platform, and approved as a Prime protocol by the IRB as reference # 811860).

Hypothesis: providing patients with financial incentives can promote healthier behaviors (e.g.: quit smoking).

Description:

This study is designed to explore the potential efficacy of using internet-based incentive programs to promote smoking cessation. We also hope to document that we can recruit participants through a web site, as well as investigate what forms of incentives show the most promise. We seek to achieve three specific objectives: (1) assess our ability to recruit participants for several different types of intervention-based smoking programs; (2) document the feasibility of using the internet to accrue and disburse incentive payments; (3) obtain preliminary assessments of which incentive structures show the most promise for future study.

Potential participants will be directed to the Way to Health research portal and will be assessed for eligibility. The web application will automatically verify eligibility based on the results of the survey. If a person is deemed eligible, he or she will be invited to consent to participate in a non-pharmacologic smoking cessation study lasting 3 months. Participants who consent will be randomized automatically to one of the 5 intervention arms (including the no-incentive arm) by the web application.

Once the participant consents and submits the necessary financial information, he will gain access to the participant interface. At this point, they will receive detailed descriptions of their assigned incentive structures (or usual care provisions), will indicate their acceptance of their assigned structure and, for those in arms 3, 4, or 5, make their required deposits. Also, he will be prompted to take an initial survey on his baseline smoking habits. The participant will be able to log into this interface at anytime and see a graph of his self-reported smoking habits along with a graph of approximately how much money he has saved compared to his baseline smoking levels. Participants will indicate their preferred method of contact: email, text-messaging, or both. Every week the participant will receive an email or text-message reminder to log in and complete a weekly smoking report. Participants can also log in at any time and report on their smoking habits for a given day or days to improve accuracy. After three months all subjects will be e-mailed to prompt them to log into the web application to take a final smoking habits survey. Participants who report having remained smoke free for the last month of the study will submit saliva (or urine, for participants using any form of nicotine replacement therapy) samples to test for cotinine (or anabasine) to verify that they have quit. Once this has been verified, the participant will be sent whatever financial incentives he has earned and any deposit will be returned.

The design of this study differs from a traditional RCT in two important ways. First, because the goal of this RCT is to focus on mechanisms of behavior change, we include a primary per-protocol analysis designed to determine incentive structures' efficacy by analyzing only participants who accept their assigned incentive structure at the time of randomization. In this analysis, the randomization arm will be entered into the analytic model as an instrumental variable to mitigate potential selection bias. As in a traditional RCT, we will also analyze each incentive structures' effectiveness using an intention-to-treat analysis that includes all randomized participants, regardless of whether they accept the randomly assigned arm. The second difference is that because acceptance rates of the different structures may differ (as we will test in Aim II), we will adapt the probabilities of being randomized to each arm on a weekly basis during the enrollment period to achieve the target numbers of participants in the per-protocol analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• 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

• Interested in quitting smoking

• Current full-time employee of Walgreens

Exclusion Criteria:

• Plan to stop working at Walgreens in the next 12 months

• Currently use a form of tobacco other than cigarettes (as this may influence biochemical testing)

• Are unable or unwilling to access the internet

• Are unable to provide informed consent

• Do not have reliable computer or internet access

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:
• 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.
• Chosen Deposits
Participants will choose their deposit amount (XX = chosen deposit); this same amount will be returned upon success (that is, quit smoking by the target quit date, and having this confirmed by cotinine/anabasine tests). If participants do not quit, their money will be used to support future research studies designed to help people stop smoking. The default deposit will be set to a certain monetary amount for consistency with other arms, and participants can increase or decrease this amount until they reach the amount they want to deposit.
• 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, and the payout for quitting on this arm will be Y 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.
• 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 and 3 months (among those eligible).

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary cotinine or urinary anabasine testing (metabolites of nicotine)	The primary measure of smoking cessation will be prolonged abstinence for 3 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 3 months following the patient-selected target quit date	No
Secondary	Salivary cotinine or urinary anabasine testing (metabolites of nicotine)	The secondary measure of smoking cessation will be point-prevalent quit rates at 14 days, which will also 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 14 days following the patient-selected target quit date	No