Financial Incentives for Smoking Treatment

Smoking Clinical Trial

— FIESTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506829
• Other study ID #: 72426
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: May 20, 2019

Study information

• Verified date: December 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: May 20, 2019
• Est. primary completion date: March 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age = 18 years,

2. smoked tobacco during the prior 30 days,

3. have an active U.S. phone number and address,

4. can provide consent in English and

5. are in at least the contemplative stage of change for quitting smoking, as assessed by a single measure, readiness to quit

Exclusion Criteria:

1. use only smokeless tobacco,

2. are pregnant or breastfeeding,

3. are discharged to an institution (e.g., nursing home, long-term care facility),

4. are unable to provide informed consent, or do not have cognitive ability to enroll or participate in the study

Related Conditions & MeSH terms

• Smoking
• Smoking, Tobacco
• Tobacco Use Disorder

Intervention

Behavioral:
• Smoking cessation counseling (Quitline)

• Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)

• Financial incentives

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
NYU Langone Health	Robert Wood Johnson Foundation, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Smoking abstinence assessed by self-report	Assessed by self-report questionnaire	6 months
Secondary	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
Secondary	Quality of life as measured by the EQ5-D and VR-12	As measured by the EQ5-D and VR-12	6 months
Secondary	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
Secondary	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

External Links

•   Financial Incentives for Smoking Cessation in Hospitalized Patients: A Randomized Clinical Trial