Incentives for Participation Versus Outcomes

Study Overview
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Brief Summary
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One of the most important debates in the field of disease prevention is whether financial incentives should be contingent on participation in evidence-based programs for smoking cessation or on actual outcomes, like prolonged abstinence. This study can fill a major knowledge gap in this debate, which is the lack of any population trial that compared the impacts of outcomes- and participation-based incentives in a population of smokers. This research can help policy makers and health service providers choose the incentives approach that provides the most effectiveness, cost-effectiveness and cost-savings for entire populations of smokers.

Detailed Description
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This population-based randomized clinical trial is designed to compare long-term abstinence rates in three groups of smokers: 1. Those incentivized for participation in an evidence-based treatment designed for smokers at each stage of change; 2. Those incentivized for biologically validated prolonged abstinence at 6 and 12 months who could also choose to participate in the TTM (Transtheoretical Model)-tailored intervention; and 3. An assessment only control condition. The Specific Aims are: To assess whether the treatment group incentivized for participation outperforms the control group at 12, 24 and 36 months as hypothesized; To assess whether the treatment group incentivized for prolonged abstinence at 6 and 12 months outperforms the control group at each follow-up as hypothesized; To assess whether the treatment group incentivized for participation outperforms the treatment group incentivized for outcomes at 36 months as hypothesized. To compare the cost-effectiveness of each treatment in a population of mostly unmotivated smokers; The Secondary Aims are: To assess the long-term treatment trajectories of each treatment compared to controls with hypothesized increasing trajectory in the participation contingent incentives and decreasing trajectory in the outcome contingent incentives. To identify mediators of long-term outcomes in each treatment, such as amount of treatment participation, income, severity of smoking, stage of change, self-efficacy, perceived health and intrinsic and extrinsic motivation to quit. To compare cost-savings of each treatment by modeling all additional costs of smoking for employers and smokers.

Official Title
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Incentives for Participation Versus Outcomes for Population Cessation of Smoking

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Incentives for Participation
* Behavioral: Incentives for Cessation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: smoker Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Participants will be incentivized for assessments only | |
| Experimental: Incentives for Participation<br>Participants will be incentivized for each assessment and for each smoking cessation session they complete | Behavioral: Incentives for Participation<br>* Participants will receive three smoking cessation programs<br>|
| Experimental: Incentives for Cessation<br>Participants will be incentivized for each assessment and biochemically confirmed abstinence at 12 and 24 months | Behavioral: Incentives for Cessation<br>* Participants will have access to a smoking cessation program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking abstinence |  | 24 months |