NCT01303081

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 2, 2012

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

February 17, 2011

Last Update Submit

August 1, 2012

Conditions

Keywords

Smoking CessationWork-siteIncentivesHealth BehaviorSmoking

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 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 and 3 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.

Behavioral: Fixed Deposits

Chosen Deposits

EXPERIMENTAL

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

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, 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)

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.

Individual Rewards
Fixed DepositsBEHAVIORAL

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.

Fixed Deposits
Chosen DepositsBEHAVIORAL

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.

Chosen Deposits

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.

Competitive Deposits (Pari-Mutuel)
Usual CareBEHAVIORAL

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).

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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
  • 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

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (39)

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MeSH Terms

Conditions

Tobacco Use DisorderSmoking CessationHealth BehaviorSmoking

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

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

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

Locations