Pilot Randomized Control Trial of Financial Incentives for Smoking Cessation

August 1, 2012 updated by: Scott Halpern, University of Pennsylvania

Financial Incentive Structures for Smoking Cessation: A Pilot Randomized Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individual Rewards
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.
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.
Active Comparator: Usual Care
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 and 3 months (among those eligible).
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 and 3 months (among those eligible).
Experimental: Fixed Deposits
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.
Behavioral: 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.
Experimental: Chosen Deposits
Same as USUAL CARE, plus financial incentive as follows: 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 or 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.
Behavioral: 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.
Experimental: Competitive Deposits (Pari-Mutuel)
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, 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary cotinine or urinary anabasine testing (metabolites of nicotine)
Time Frame: at 3 months following the patient-selected target quit date
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary cotinine or urinary anabasine testing (metabolites of nicotine)
Time Frame: at 14 days following the patient-selected target quit date
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: David Asch, MD, MBA, University of Pennsylvania
  • Principal Investigator: Scott Halpern, MD, Ph.D., University of Pennsylvania, Department of Medicine, Pulmonary, Allergy and Critical Care
  • Principal Investigator: Kevin Volpp, MD, Ph.D., University of Pennsylvania
  • Principal Investigator: Benjamin French, MS, Ph.D., University of Pennsylvania
  • Principal Investigator: Dylan Small, Ph.D., University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

February 17, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (Estimate)

February 24, 2011

Study Record Updates

Last Update Posted (Estimate)

August 2, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 812287
  • RC2AG036592 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tobacco Use Disorder

  • University of California, San Francisco
    Tobacco Related Disease Research Program
    Recruiting
    Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness (EXIT)
    Tobacco Cessation | Tobacco Use | Tobacco Use Cessation | Tobacco Dependence | Tobacco Abstinence
    United States
  • Washington University School of Medicine
    National Cancer Institute (NCI); National Institutes of Health (NIH)
    Completed
    Helping Poor Smokers Quit
    Smoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Nicotine Dependence | Tobacco Dependence | Smoking, Tobacco | Nicotine Use Disorder | Nicotine Dependence, Cigarettes | Smoking, Cigarette | Nicotine Dependence Tobacco Product | Tobacco; Use, Rehabilitation | Smoking (Tobacco) Addiction and other conditions
    United States
  • University of Utah
    National Cancer Institute (NCI)
    Recruiting
    Reach Through Equitable Implementation in Utah (REI-UT)
    Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Tobacco Dependence | Tobacco Chewing
    United States
  • Harvard School of Public Health (HSPH)
    Beacon Communities; The Community Builders
    Enrolling by invitation
    Enhancing Equity in Smoke-free Housing
    Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Second Hand Tobacco Smoke
    United States
  • Johns Hopkins University
    National Institute on Drug Abuse (NIDA)
    Recruiting
    Oral Cannabidiol for Tobacco Cessation
    Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence
    United States
  • University of California, San Francisco
    Tobacco Related Disease Research Program
    Completed
    An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers (POP-6)
    Smoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence | Smoking, Tobacco | Smoking, Cigarette
    United States
  • University of California, San Francisco
    National Institute on Drug Abuse (NIDA); National Institute on Minority Health...
    Completed
    A Facebook Intervention for Young Sexual and Gender Minority Smokers (POP)
    Smoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence | Smoking, Tobacco | Smoking, Cigarette
    United States
  • Centre for Addiction and Mental Health
    Canadian Cancer Society (CCS)
    Recruiting
    Smoking Cessation and Menstrual Cycle Phase (MC-NRT)
    Smoking Cessation | Tobacco Smoking | Substance Use Disorders | Nicotine Dependence | Nicotine Use Disorder
    Canada
  • Rutgers, The State University of New Jersey
    National Institute on Drug Abuse (NIDA)
    Completed
    Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI) (PTSC-S)
    Schizophrenia | Schizoaffective Disorder | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation
    United States
  • Indiana University
    National Institute on Drug Abuse (NIDA)
    Recruiting
    Temporal Interference Methods for Addiction Treatment
    Substance Use Disorders | Nicotine Use Disorder
    United States

Clinical Trials on Individual Rewards

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe