Financial Incentives for Smoking Treatment

Study Overview
=================
Brief Summary
-----------------
The investigators plan to compare the impact of two approaches for smoking cessation on smoking abstinence, use of evidenced-based therapy, and quality of life among a diverse population of patients at the Manhattan campus of the VA New York Harbor Healthcare System, which serves a critical safety-net role for urban veterans. During hospitalization, all smokers will receive usual care. Patients will be randomized to one of two arms: financial incentives plus usual care vs. usual care alone, which includes referral to the state Quitline. All patients enrolled in the study will be offered nicotine replacement therapy. The investigators will conduct follow-up assessments at 2 weeks, 2 months, 6 months and 12 months after discharge. The primary study outcome is smoking abstinence at 6-month follow-up, verified by salivary/urinary cotinine.

Official Title
-----------------
A Randomized Comparative Effectiveness Trial Of Financial Incentives Versus Usual Care For Smokers Hospitalized In The Veterans Affairs Hospital System

Conditions
-----------------
Smoking, Smoking, Tobacco, Tobacco Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Smoking cessation counseling (Quitline)
* Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)
* Behavioral: Financial incentives


Participation Criteria
=================
Eligibility Criteria
-----------------
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 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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>Usual care in hospital, referral to a smoking cessation Quitline on discharge from hospital. | Behavioral: Smoking cessation counseling (Quitline)<br> <br> Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)<br> <br> |
| Experimental: Financial Incentives<br>Usual care in hospital, referral to a smoking cessation Quitline on discharge from hospital. Financial incentives for: a) speaking with a coach from the Smoker's Quitline ($50), b) completion of another community-based smoking-cessation program ($50), and/or c) use of pharmacotherapies for smoking cessation at 2 weeks ($50); and d) for smoking cessation, confirmed with the use of a cotinine test at 2 months ($150); and e) for smoking cessation, confirmed with the use of a cotinine test at 6 months after study enrollment ($250). | Behavioral: Smoking cessation counseling (Quitline)<br> <br> Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)<br> <br> Behavioral: Financial incentives<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking abstinence assessed by self-reported 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 |
| --- | --- | --- |
| Smoking abstinence assessed by self-report | Assessed by self-report questionnaire | 6 months | 
| 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 weeks and 2 months | 
| Quality of life as measured by the EQ5-D and VR-12 | As measured by the EQ5-D and VR-12 | 6 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inpatients