Clinical trial NCT01826331: Incentives for Participation Versus Outcomes
Official title: Incentives for Participation Versus Outcomes for Population Cessation of Smoking
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Smoking
Lead sponsor: University of Rhode Island
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* smoker

Exclusion Criteria:

-

Primary outcomes:
measure: Smoking abstinence
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: United States
facility: University of Rhode Island
state: Rhode Island
Study officials:
affiliation: University of Rhode Island
name: James O Prochaska, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: