Financial Incentives for Smoking Treatment II
FIESTA II
1 other identifier
interventional
1,058
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2019
CompletedFirst Posted
Study publicly available on registry
June 7, 2019
CompletedStudy Start
First participant enrolled
January 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
ExpectedApril 29, 2026
April 1, 2026
5.3 years
June 4, 2019
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Use of evidence based treatment (e.g. counseling and smoking cessation medications) 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
12 months
Short term return on investment of using financial incentives to promote smoking cessation (Cost analysis)
12 months
Long term return on investment of using financial incentives to promote smoking cessation (Cost analysis)
3 years
Study Arms (3)
Goal-Directed Incentives
OTHEROutcome-Based Incentives
OTHEREnhanced Usual Care
OTHERInterventions
Quitline offers community-based counseling session with a cessation counselor.
Participants will be encouraged to speak to their doctors about using highly effective pharmacotherapies for smoking cessation.
Participants will receive financial incentives for bioconfirmed smoking cessation.
Participants will receive financial incentives for the use of evidence-based smoking cessation therapies including Quitline counseling, community-based smoking cessation programs and pharmacotherapies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Los Angeleslead
- NYU Langone Healthcollaborator
- Olive View-UCLA Education & Research Institutecollaborator
Study Sites (2)
David Geffen School of Medicine
Los Angeles, California, 90095, United States
NYU Langone Health
New York, New York, 10016, United States
Related Publications (1)
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.
PMID: 37775282DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Ladapo, MD, PhD
University of California, Los Angeles
- PRINCIPAL INVESTIGATOR
Scott Sherman, MD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 4, 2019
First Posted
June 7, 2019
Study Start
January 6, 2020
Primary Completion
April 7, 2025
Study Completion (Estimated)
June 30, 2027
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.