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

NCT01526265 | Completed DMC

• 2 other identifiers: 814761R01CA159932
• Study Type: interventional
• Target: 2,185
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Use Disorder

Keywords

Smoking Cessation; Work-site; Incentives; Health Behavior; Smoking

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Salivary cotinine or anabasine testing (metabolites of nicotine)

  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.

Study Arms (5)

Usual Care

ACTIVE COMPARATOR

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

Individual Rewards

EXPERIMENTAL

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

Fixed Deposits

EXPERIMENTAL

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

Competitive Deposits (Pari-Mutuel)

EXPERIMENTAL

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)

Collaborative Rewards

EXPERIMENTAL

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

Interventions

Usual Care BEHAVIORAL

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).

Usual Care

Individual Rewards BEHAVIORAL

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.

Individual Rewards

Fixed Deposits BEHAVIORAL

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.

Fixed Deposits

Competitive Deposits (Pari-Mutuel) BEHAVIORAL

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.

Competitive Deposits (Pari-Mutuel)

Collaborative Rewards BEHAVIORAL

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.

Collaborative Rewards

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

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MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation; Health Behavior; Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

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: January 31, 2012
• First Posted: February 3, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

US (1)