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

NCT ID: NCT01526265

Last Updated: 2016-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type 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).

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.

Group Type EXPERIMENTAL

Individual Rewards

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Fixed Deposits

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Competitive Deposits (Pari-Mutuel)

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Collaborative Rewards

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott Halpern, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania, Department of Medicine, Pulmonary, Allergy and Critical Care

Kevin Volpp, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Benjamin French, MS, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Dylan Small, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

David Asch, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Janet Audrain-McGovern, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01CA159932

Identifier Type: NIH

Identifier Source: secondary_id

View Link

814761

Identifier Type: -

Identifier Source: org_study_id

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