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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44AG044872-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Rhode Island Primary Care Physicians Corporation | UNKNOWN |
| Pro-Change Behavior Systems | OTHER |
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The purpose of this study is to determine whether a behavioral economics solution impacts smoking cessation program engagement and quit rates.
The behavioral economics solution is a weekly regret contest in which participants can win or miss out on money based on their behavior.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care with minimal incentives | Other | Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study. |
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| Usual care with BE incentives | Active Comparator | Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral economics incentives | Behavioral | Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention. |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Completed Sessions Per Participant | Engagement rates for the intervention will be higher relative to the control arm. Engagement is measured by the number of complete tobacco cessation sessions per participant. | Every 30 days for up to 6 months post-enrollment |
| Outcome of Smoking Cessation Intervention | Quit levels for the intervention will be higher relative to the control arm. Quit level is defined as a participant who progresses to the stage in the tobacco cessation program where they quit smoking. The quit stages are levels 4 and 5 of the tobacco cessation program. | Every 30 days for up to 6 months post-enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Horgan, MBA | President | Principal Investigator |
| Kevin Volpp, MD, PhD | Scientific Advisory Board | Study Director |
| David Asch, MD | Scientific Advisory Board | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VAL Health | Old Greenwich | Connecticut | 06870 | United States |
Individual participant data will not be made available to other researchers.
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We identified and discontinued 34 participants whose accounts were were flagged as being suspicious. Duplicate accounts were erroneously created by a participant and thus were removed from the study. Suspicious accounts contained personal information identical to existing participants and after investigation, were concluded to be fraudulent.
Recruitment period: January to March, 2016. Recruitment methods: Physician and nurse referrals from Rhode Island Primary Care Physicians Corporation and Facebook advertisements.
Intake method: Digital intake form hosted by Pro-Change.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care With Minimal Incentives | Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study. Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention. |
| FG001 | Usual Care With BE Incentives | Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study. Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care With Minimal Incentives | Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study. Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Number of Completed Sessions Per Participant | Engagement rates for the intervention will be higher relative to the control arm. Engagement is measured by the number of complete tobacco cessation sessions per participant. | Posted | Mean | Inter-Quartile Range | Average Number of Sessions | Every 30 days for up to 6 months post-enrollment | Sessions | Sessions |
|
Up to 6 months post-enrollment.
No adverse events reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care With Minimal Incentives | Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study. Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Astrachan | VAL HEALTH, LLC | 2033769388 | dastrachan@valhealth.com |
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| Minimal incentives | Other | Minimal financial incentives to promote engagement and outcomes in a smoking cessation intervention. |
|
| BG001 |
| Usual Care With BE Incentives |
Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study. Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study. Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention. |
|
|
|
| Primary | Outcome of Smoking Cessation Intervention | Quit levels for the intervention will be higher relative to the control arm. Quit level is defined as a participant who progresses to the stage in the tobacco cessation program where they quit smoking. The quit stages are levels 4 and 5 of the tobacco cessation program. | Posted | Count of Participants | Participants | Every 30 days for up to 6 months post-enrollment |
|
|
|
| 0 |
| 210 |
| 0 |
| 210 |
| 0 |
| 210 |
| EG001 | Usual Care With BE Incentives | Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study. Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention. | 0 | 212 | 0 | 212 | 0 | 212 |
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