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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Scott Halpern, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01526265
First received: January 31, 2012
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Tobacco Use Disorder
Behavioral: Usual Care
Behavioral: Individual Rewards
Behavioral: Fixed Deposits
Behavioral: Competitive Deposits (Pari-Mutuel)
Behavioral: Collaborative Rewards

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Way to Quit - Comparative Efficacy, Acceptance and Effectiveness of Health Incentive Structures

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Salivary cotinine or anabasine testing (metabolites of nicotine) [ Time Frame: at 6 months following the patient selected target quit date. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 2185
Study Start Date: February 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, 30 days, 6 months, and 12 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, 30 days, 6 months, and 12 months (among those eligible).
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.
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. As a motivation to quit smoking, the participant's deposit will be matched by the study investigators in a rate of 3:1.
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. As a motivation to quit smoking, the participant's deposit will be matched by the study investigators in a rate of 3:1.
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, 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.
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, 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: Collaborative Rewards
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.
Behavioral: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526265

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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
Principal Investigator: Janet Audrain-McGovern, Ph.D. University of Pennsylvania
  More Information

Publications:
Dragalin V. Adaptive designs: Terminology and classification. Drug Information Journal 2006;40(4):425-35.
Hatsukami DK, Stead LF, Gupta PC. Tobacco addiction. Lancet 2008;371(9629):2027-38.

Responsible Party: Scott Halpern, Assistant Professor of Medicine and Epidemiology , Division of Pulmonary and Critical Care Medicine, Senior Fellow, Center for Bioethics & Leonard Davis Institute of Health Economics, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01526265     History of Changes
Other Study ID Numbers: 814761, R01CA159932
Study First Received: January 31, 2012
Last Updated: April 16, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pennsylvania:
Smoking Cessation
Work-site
Incentives
Health Behavior
Smoking

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on October 23, 2014