Financial Incentives for Smoking Treatment II (FIESTA II)

Financial Incentives for Smoking Treatment

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Smoking Cessation; Tobacco Use Cessation
• Intervention / Treatment: Behavioral: Smoking cessation counseling (Quitline); Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy); Behavioral: Financial incentives for use of evidence-based smoking cessation therapies; Behavioral: Financial incentives for smoking cessation

• Study Type: Interventional
• Enrollment (Estimated): 1058
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • David Geffen School of Medicine
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Enhanced Usual Care	Behavioral: Smoking cessation counseling (Quitline); Quitline offers community-based counseling session with a cessation counselor.; Behavioral: 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.
Other: Goal-Directed Incentives	Behavioral: Smoking cessation counseling (Quitline); Quitline offers community-based counseling session with a cessation counselor.; Behavioral: 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.; Behavioral: 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
Other: Outcome-Based Incentives	Behavioral: Smoking cessation counseling (Quitline); Quitline offers community-based counseling session with a cessation counselor.; Behavioral: 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.; Behavioral: Financial incentives for smoking cessation; Participants will receive financial incentives for bioconfirmed smoking cessation.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: NYU Langone Health; Olive View-UCLA Education & Research Institute
• Investigators: Principal Investigator: Joseph Ladapo, MD, PhD, University of California, Los Angeles; Principal Investigator: Scott Sherman, MD, NYU Langone Health

Publications and helpful links

General Publications

• Wali S, Gaitonde A, Sherman S, Min N, Pesantes A, Bidgoli A, Shirley A, Tseng CH, Ladapo J. Goal-directed versus outcome-based financial incentives for smoking cessation among low-income, hospitalised patients: rationale and design of the Financial Incentives for Smoking Treatment II (FIESTA II) randomised controlled trial. BMJ Open. 2023 Sep 29;13(9):e074354. doi: 10.1136/bmjopen-2023-074354.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): April 7, 2025
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation; Tobacco Use Cessation; Therapeutics; Drug Therapy; Nicotine Replacement Therapy
• Other Study ID Numbers: R01DA045688-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

UCLA is committed to the ideals of collaborative research and adheres to the sponsors Grant Policy on Sharing of Unique Research Resources. Requests for research resources generated as part of this project will be distributed in a timely manner.

Publication of data shall occur during or at the end of the project, consistent with normal scientific practices. Research data that documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Data will be redacted to prevent the disclosure of personal identifiers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No