Financial Incentives for Smoking Treatment II

Smoking Cessation Clinical Trial

— FIESTA II  

Official title:

Financial Incentives for Smoking Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03979885
• Other study ID #: R01DA045688-01A1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1058
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• 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 or Spanish 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 Cessation
• Tobacco Use Cessation

Intervention

Behavioral:
• Smoking cessation counseling (Quitline)
Quitline offers community-based counseling session with a cessation counselor.
• Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)
Participants will be encouraged to speak to their doctors about using highly effective pharmacotherapies for smoking cessation.
• Financial incentives for smoking cessation
Participants will receive financial incentives for bioconfirmed smoking cessation.
• Financial incentives for use of evidence-based smoking cessation therapies
Participants will receive financial incentives for the use of evidence-based smoking cessation therapies including Quitline counseling, community-based smoking cessation programs and pharmacotherapies

Locations

Country	Name	City	State
United States	David Geffen School of Medicine	Los Angeles	California
United States	NYU Langone Health	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	NYU Langone Health, Olive View-UCLA Education & Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Quality of life as measured by PROMIS-29 Profile v2.0	Assessed by phone interviews.	12 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