Incentives for Participation Versus Outcomes

NCT ID: NCT01826331

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2019-05-31

Brief Summary

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

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:

1. To assess whether the treatment group incentivized for participation outperforms the control group at 12, 24 and 36 months as hypothesized;

2. 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;

3. To assess whether the treatment group incentivized for participation outperforms the treatment group incentivized for outcomes at 36 months as hypothesized.

4. To compare the cost-effectiveness of each treatment in a population of mostly unmotivated smokers;

The Secondary Aims are:

1. 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.

2. 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.

3. To compare cost-savings of each treatment by modeling all additional costs of smoking for employers and smokers.

Conditions

Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Control Group

Participants will be incentivized for assessments only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Incentives for Participation

Participants will be incentivized for each assessment and for each smoking cessation session they complete

Group Type: EXPERIMENTAL

Incentives for Participation

Intervention Type: BEHAVIORAL

Participants will receive three smoking cessation programs

Incentives for Cessation

Participants will be incentivized for each assessment and biochemically confirmed abstinence at 12 and 24 months

Group Type: EXPERIMENTAL

Incentives for Cessation

Intervention Type: BEHAVIORAL

Participants will have access to a smoking cessation program

Interventions

Incentives for Participation

Participants will receive three smoking cessation programs

Intervention Type: BEHAVIORAL

Incentives for Cessation

Participants will have access to a smoking cessation program

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• smoker

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rhode Island

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James O Prochaska, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Rhode Island

Locations

University of Rhode Island

Kingston, Rhode Island, United States

Countries

United States

Other Identifiers

DA034041

Identifier Type: -

Identifier Source: org_study_id