Clinical trial NCT01526265: Way to Quit - Comparative Efficacy, Acceptance and Effectiveness of Health Incentive Structures
Official title: Way to Quit - Comparative Efficacy, Acceptance and Effectiveness of Health Incentive Structures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: Smoking Cessation
Work-site
Incentives
Health Behavior
Smoking
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2012-02-03
Enrollment: 2185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Salivary cotinine or anabasine testing (metabolites of nicotine)
timeFrame: at 6 months following the patient selected target quit date.
Secondary outcomes:
measure: Salivary cotinine or anabasine testing (metabolites of nicotine)
timeFrame: 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.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania, Department of Medicine, Pulmonary, Allergy and Critical Care
name: Scott Halpern, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Kevin Volpp, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Benjamin French, MS, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Dylan Small, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: David Asch, MD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Janet Audrain-McGovern, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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