Financial Incentives for Smoking Treatment II

Study Overview
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Brief Summary
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Financial incentives for motivating changes in health behavior, particularly for smoking and other morbid habits, are increasingly being tested by health insurers, employers, and government agencies. However, in using incentive programs for smoking cessation, key unanswered structural and theoretical questions remain regarding their effectiveness, acceptability to patients, and economic sustainability. This trial aims to advance the science and implementation of financial incentives for smoking cessation interventions among high-risk, hospitalized smokers. The investigators will pursue two specific aims: 1) comparing the impact of three approaches for smoking cessation on smoking abstinence, use of evidenced-based therapy, and quality of life and 2) comparing the short-term and long term return on investment of using goal directed and outcome-based financial incentives to promote smoking cessation.

Official Title
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Financial Incentives for Smoking Treatment

Conditions
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Smoking Cessation, Tobacco Use Cessation

Intervention / Treatment
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* Behavioral: Smoking cessation counseling (Quitline)
* Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)
* Behavioral: Financial incentives for smoking cessation
* Behavioral: Financial incentives for use of evidence-based smoking cessation therapies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years smoked tobacco during the prior 30 days, have an active U.S. phone number and address, can provide consent in English or Spanish and are in at least the contemplative stage of change for quitting smoking, as assessed by a single measure, readiness to quit Exclusion Criteria: use only smokeless tobacco, are pregnant or breastfeeding, are discharged to an institution (e.g., nursing home, long-term care facility), are unable to provide informed consent, or do not have cognitive ability to enroll or participate in the study

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Goal-Directed Incentives<br> | Behavioral: Smoking cessation counseling (Quitline)<br>* Quitline offers community-based counseling session with a cessation counselor.<br>Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)<br>* Participants will be encouraged to speak to their doctors about using highly effective pharmacotherapies for smoking cessation.<br>Behavioral: Financial incentives for use of evidence-based smoking cessation therapies<br>* Participants will receive financial incentives for the use of evidence-based smoking cessation therapies including Quitline counseling, community-based smoking cessation programs and pharmacotherapies<br>|
| Other: Outcome-Based Incentives<br> | Behavioral: Smoking cessation counseling (Quitline)<br>* Quitline offers community-based counseling session with a cessation counselor.<br>Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)<br>* Participants will be encouraged to speak to their doctors about using highly effective pharmacotherapies for smoking cessation.<br>Behavioral: Financial incentives for smoking cessation<br>* Participants will receive financial incentives for bioconfirmed smoking cessation.<br>|
| Other: Enhanced Usual Care<br> | Behavioral: Smoking cessation counseling (Quitline)<br>* Quitline offers community-based counseling session with a cessation counselor.<br>Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)<br>* Participants will be encouraged to speak to their doctors about using highly effective pharmacotherapies for smoking cessation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking abstinence assessed by self-report and biochemically verified by salivary cotinine | Assessed by self-report questionnaire, and biochemically verified by salivary cotinine | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of evidence based treatment (e.g. counseling and smoking cessation medications) assessed by discharge prescriptions, Quitline records, receipts, letters and/or self-report | Assessed by discharge prescriptions, Quitline records, receipts, letters and/or self-report | 2 months | 
| Quality of life as measured by PROMIS-29 Profile v2.0 | Assessed by phone interviews. | 12 months | 
| Short term return on investment of using financial incentives to promote smoking cessation (Cost analysis) | Cost analysis involving hospital utilization data, electronic health records and patient-reported healthcare utilization | 12 months | 
| Long term return on investment of using financial incentives to promote smoking cessation (Cost analysis) | Cost analysis involving hospital utilization data, electronic health records and patient-reported healthcare utilization | 3 years |