Pilot Randomized Control Trial of Financial Incentives for Smoking Cessation
Financial Incentive Structures for Smoking Cessation: A Pilot Randomized Trial
2 other identifiers
interventional
63
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2011
CompletedFirst Posted
Study publicly available on registry
February 24, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedAugust 2, 2012
August 1, 2012
1 year
February 17, 2011
August 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Salivary cotinine or urinary anabasine testing (metabolites of nicotine)
at 14 days following the patient-selected target quit date
Study Arms (5)
Usual Care
ACTIVE COMPARATORParticipants 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).
Individual Rewards
EXPERIMENTALSame 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.
Fixed Deposits
EXPERIMENTALSame 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.
Chosen Deposits
EXPERIMENTALSame 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.
Competitive Deposits (Pari-Mutuel)
EXPERIMENTALSame 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.
Interventions
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.
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.
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.
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.
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (39)
Halpern SD, Madison KM, Volpp KG. Patients as mercenaries?: the ethics of using financial incentives in the war on unhealthy behaviors. Circ Cardiovasc Qual Outcomes. 2009 Sep;2(5):514-6. doi: 10.1161/CIRCOUTCOMES.109.871855. No abstract available.
PMID: 20031885BACKGROUNDVolpp KG, Pauly MV, Loewenstein G, Bangsberg D. P4P4P: an agenda for research on pay-for-performance for patients. Health Aff (Millwood). 2009 Jan-Feb;28(1):206-14. doi: 10.1377/hlthaff.28.1.206.
PMID: 19124872BACKGROUNDVolpp KG, Troxel AB, Pauly MV, Glick HA, Puig A, Asch DA, Galvin R, Zhu J, Wan F, DeGuzman J, Corbett E, Weiner J, Audrain-McGovern J. A randomized, controlled trial of financial incentives for smoking cessation. N Engl J Med. 2009 Feb 12;360(7):699-709. doi: 10.1056/NEJMsa0806819.
PMID: 19213683BACKGROUNDLussier JP, Heil SH, Mongeon JA, Badger GJ, Higgins ST. A meta-analysis of voucher-based reinforcement therapy for substance use disorders. Addiction. 2006 Feb;101(2):192-203. doi: 10.1111/j.1360-0443.2006.01311.x.
PMID: 16445548BACKGROUNDMokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA. 2004 Mar 10;291(10):1238-45. doi: 10.1001/jama.291.10.1238.
PMID: 15010446BACKGROUNDHughes JR. Motivating and helping smokers to stop smoking. J Gen Intern Med. 2003 Dec;18(12):1053-7. doi: 10.1111/j.1525-1497.2003.20640.x.
PMID: 14687265BACKGROUNDHennrikus DJ, Jeffery RW, Lando HA, Murray DM, Brelje K, Davidann B, Baxter JS, Thai D, Vessey J, Liu J. The SUCCESS project: the effect of program format and incentives on participation and cessation in worksite smoking cessation programs. Am J Public Health. 2002 Feb;92(2):274-9. doi: 10.2105/ajph.92.2.274.
PMID: 11818305BACKGROUNDDonatelle R, Hudson D, Dobie S, Goodall A, Hunsberger M, Oswald K. Incentives in smoking cessation: status of the field and implications for research and practice with pregnant smokers. Nicotine Tob Res. 2004 Apr;6 Suppl 2:S163-79. doi: 10.1080/14622200410001669196.
PMID: 15203819BACKGROUNDVolpp KG, Gurmankin Levy A, Asch DA, Berlin JA, Murphy JJ, Gomez A, Sox H, Zhu J, Lerman C. A randomized controlled trial of financial incentives for smoking cessation. Cancer Epidemiol Biomarkers Prev. 2006 Jan;15(1):12-8. doi: 10.1158/1055-9965.EPI-05-0314.
PMID: 16434580BACKGROUNDCoffield AB, Maciosek MV, McGinnis JM, Harris JR, Caldwell MB, Teutsch SM, Atkins D, Richland JH, Haddix A. Priorities among recommended clinical preventive services. Am J Prev Med. 2001 Jul;21(1):1-9. doi: 10.1016/s0749-3797(01)00308-7.
PMID: 11418251BACKGROUNDCromwell J, Bartosch WJ, Fiore MC, Hasselblad V, Baker T. Cost-effectiveness of the clinical practice recommendations in the AHCPR guideline for smoking cessation. Agency for Health Care Policy and Research. JAMA. 1997 Dec 3;278(21):1759-66.
PMID: 9388153BACKGROUNDHalpern SD, Karlawish JH, Casarett D, Berlin JA, Asch DA. Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials. Arch Intern Med. 2004 Apr 12;164(7):801-3. doi: 10.1001/archinte.164.7.801.
PMID: 15078651BACKGROUNDHalpern SD, Raz A, Kohn R, Rey M, Asch DA, Reese P. Regulated payments for living kidney donation: an empirical assessment of the ethical concerns. Ann Intern Med. 2010 Mar 16;152(6):358-65. doi: 10.7326/0003-4819-152-6-201003160-00005.
PMID: 20231566BACKGROUNDAudrain J, Boyd NR, Roth J, Main D, Caporaso NF, Lerman C. Genetic susceptibility testing in smoking-cessation treatment: one-year outcomes of a randomized trial. Addict Behav. 1997 Nov-Dec;22(6):741-51. doi: 10.1016/s0306-4603(97)00060-9.
PMID: 9426791BACKGROUNDHeatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
PMID: 1932883BACKGROUNDPomerleau CS, Carton SM, Lutzke ML, Flessland KA, Pomerleau OF. Reliability of the Fagerstrom Tolerance Questionnaire and the Fagerstrom Test for Nicotine Dependence. Addict Behav. 1994 Jan-Feb;19(1):33-9. doi: 10.1016/0306-4603(94)90049-3.
PMID: 8197891BACKGROUNDHymowitz N, Cummings KM, Hyland A, Lynn WR, Pechacek TF, Hartwell TD. Predictors of smoking cessation in a cohort of adult smokers followed for five years. Tob Control. 1997;6 Suppl 2(Suppl 2):S57-62. doi: 10.1136/tc.6.suppl_2.s57.
PMID: 9583654BACKGROUNDKenford SL, Fiore MC, Jorenby DE, Smith SS, Wetter D, Baker TB. Predicting smoking cessation. Who will quit with and without the nicotine patch. JAMA. 1994 Feb 23;271(8):589-94. doi: 10.1001/jama.271.8.589.
PMID: 8301790BACKGROUNDGiuffrida A, Torgerson DJ. Should we pay the patient? Review of financial incentives to enhance patient compliance. BMJ. 1997 Sep 20;315(7110):703-7. doi: 10.1136/bmj.315.7110.703.
PMID: 9314754BACKGROUNDDelmonico FL, Arnold R, Scheper-Hughes N, Siminoff LA, Kahn J, Youngner SJ. Ethical incentives--not payment--for organ donation. N Engl J Med. 2002 Jun 20;346(25):2002-5. doi: 10.1056/NEJMsb013216. No abstract available.
PMID: 12075064BACKGROUNDDickert N, Grady C. What's the price of a research subject? Approaches to payment for research participation. N Engl J Med. 1999 Jul 15;341(3):198-203. doi: 10.1056/NEJM199907153410312. No abstract available.
PMID: 10403861BACKGROUNDMacklin R. On paying money to research subjects: 'due' and 'undue' inducements. IRB. 1981 May;3(5):1-6. No abstract available.
PMID: 11649367BACKGROUNDDiClemente CC, Prochaska JO, Fairhurst SK, Velicer WF, Velasquez MM, Rossi JS. The process of smoking cessation: an analysis of precontemplation, contemplation, and preparation stages of change. J Consult Clin Psychol. 1991 Apr;59(2):295-304. doi: 10.1037//0022-006x.59.2.295.
PMID: 2030191BACKGROUNDBrownson RC, Eriksen MP, Davis RM, Warner KE. Environmental tobacco smoke: health effects and policies to reduce exposure. Annu Rev Public Health. 1997;18:163-85. doi: 10.1146/annurev.publhealth.18.1.163.
PMID: 9143716BACKGROUNDAudrain-McGovern J, Rodriguez D, Epstein LH, Rodgers K, Cuevas J, Wileyto EP. Young adult smoking: what factors differentiate ex-smokers, smoking cessation treatment seekers and nontreatment seekers? Addict Behav. 2009 Dec;34(12):1036-41. doi: 10.1016/j.addbeh.2009.06.012. Epub 2009 Jul 5.
PMID: 19619948BACKGROUNDAudrain-McGovern J, Rodriguez D, Epstein LH, Cuevas J, Rodgers K, Wileyto EP. Does delay discounting play an etiological role in smoking or is it a consequence of smoking? Drug Alcohol Depend. 2009 Aug 1;103(3):99-106. doi: 10.1016/j.drugalcdep.2008.12.019. Epub 2009 May 14.
PMID: 19443136BACKGROUNDBickel WK, Odum AL, Madden GJ. Impulsivity and cigarette smoking: delay discounting in current, never, and ex-smokers. Psychopharmacology (Berl). 1999 Oct;146(4):447-54. doi: 10.1007/pl00005490.
PMID: 10550495BACKGROUNDJohnson MW, Bickel WK, Baker F. Moderate drug use and delay discounting: a comparison of heavy, light, and never smokers. Exp Clin Psychopharmacol. 2007 Apr;15(2):187-94. doi: 10.1037/1064-1297.15.2.187.
PMID: 17469942BACKGROUNDKirby KN, Petry NM, Bickel WK. Heroin addicts have higher discount rates for delayed rewards than non-drug-using controls. J Exp Psychol Gen. 1999 Mar;128(1):78-87. doi: 10.1037//0096-3445.128.1.78.
PMID: 10100392BACKGROUNDBaker F, Johnson MW, Bickel WK. Delay discounting in current and never-before cigarette smokers: similarities and differences across commodity, sign, and magnitude. J Abnorm Psychol. 2003 Aug;112(3):382-92. doi: 10.1037/0021-843x.112.3.382.
PMID: 12943017BACKGROUNDJacob P 3rd, Wilson M, Benowitz NL. Improved gas chromatographic method for the determination of nicotine and cotinine in biologic fluids. J Chromatogr. 1981 Jan 2;222(1):61-70. doi: 10.1016/s0378-4347(00)81033-6.
PMID: 6783675BACKGROUNDJacob P 3rd, Yu L, Wilson M, Benowitz NL. Selected ion monitoring method for determination of nicotine, cotinine and deuterium-labeled analogs: absence of an isotope effect in the clearance of (S)-nicotine-3',3'-d2 in humans. Biol Mass Spectrom. 1991 May;20(5):247-52. doi: 10.1002/bms.1200200503.
PMID: 1883864BACKGROUNDGreenland S, Schwartzbaum JA, Finkle WD. Problems due to small samples and sparse data in conditional logistic regression analysis. Am J Epidemiol. 2000 Mar 1;151(5):531-9. doi: 10.1093/oxfordjournals.aje.a010240.
PMID: 10707923BACKGROUNDHiggins ST, Heil SH, Dantona R, Donham R, Matthews M, Badger GJ. Effects of varying the monetary value of voucher-based incentives on abstinence achieved during and following treatment among cocaine-dependent outpatients. Addiction. 2007 Feb;102(2):271-81. doi: 10.1111/j.1360-0443.2006.01664.x.
PMID: 17222282BACKGROUNDCenters for Disease Control and Prevention (CDC). State-specific smoking-attributable mortality and years of potential life lost--United States, 2000-2004. MMWR Morb Mortal Wkly Rep. 2009 Jan 23;58(2):29-33.
PMID: 19165137BACKGROUNDHatsukami DK, Stead LF, Gupta PC. Tobacco addiction. Lancet. 2008 Jun 14;371(9629):2027-38. doi: 10.1016/S0140-6736(08)60871-5.
PMID: 18555914BACKGROUNDCenters for Disease Control and Prevention (CDC). Cigarette smoking among adults and trends in smoking cessation - United States, 2008. MMWR Morb Mortal Wkly Rep. 2009 Nov 13;58(44):1227-32.
PMID: 19910909BACKGROUNDDonatelle RJ, Prows SL, Champeau D, Hudson D. Randomised controlled trial using social support and financial incentives for high risk pregnant smokers: significant other supporter (SOS) program. Tob Control. 2000;9 Suppl 3(Suppl 3):III67-9. doi: 10.1136/tc.9.suppl_3.iii67. No abstract available.
PMID: 10982912BACKGROUNDProchaska JO, DiClemente CC, Velicer WF, Rossi JS. Standardized, individualized, interactive, and personalized self-help programs for smoking cessation. Health Psychol. 1993 Sep;12(5):399-405. doi: 10.1037//0278-6133.12.5.399.
PMID: 8223364BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
- PRINCIPAL INVESTIGATOR
David Asch, MD, MBA
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine and Epidemiology , Division of Pulmonary and Critical Care Medicine, Senior Fellow, Center for Bioethics & Leonard Davis Institute of Health Economics
Study Record Dates
First Submitted
February 17, 2011
First Posted
February 24, 2011
Study Start
June 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
August 2, 2012
Record last verified: 2012-08