SmokingFIESTANCT02506829
Financial Incentives for Smoking Treatment
A study testing Smoking cessation counseling (Quitline), Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy) and Financial incentives in people with Smoking and Smoking, Tobacco, run by NYU Langone Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Smoking, Tobacco, Tobacco Use Disorder
- What is being tested?
- Smoking cessation counseling (Quitline), Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy) and Financial incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 20 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: A Randomized Comparative Effectiveness Trial Of Financial Incentives Versus Usual Care For Smokers Hospitalized In The Veterans Affairs Hospital System
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.
- Conditions
- Smoking, Smoking, Tobacco, Tobacco Use Disorder
- Being tested
- Smoking cessation counseling (Quitline), Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy), Financial incentives
- Keywords
- Inpatients
- Medical subject headings
- Smoking, Tobacco Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation counseling (Quitline)Behavioural
Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)Behavioural
Financial incentivesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Usual care in hospital, referral to a smoking cessation Quitline on discharge from hospital. Receives: Behavioral: Smoking cessation counseling (Quitline); Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy) |
| Financial Incentives | Experimental | 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). Receives: Behavioral: Smoking cessation counseling (Quitline); Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy); Behavioral: Financial incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence assessed by self-reported and biochemically verified by salivary cotinine
Assessed by self-report questionnaire, and biochemically verified by salivary cotinine
Measured: 6 months
Secondary outcomes (5)
Smoking abstinence assessed by self-report
Assessed by self-report questionnaire
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion5 Mar 2019
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Joseph Ladapo, MD, PhD, Principal investigator, University of California, Los AngelesScott Sherman, MD, MPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506829
- Sponsor's protocol ID
- 72426
- Acronym
- FIESTA
- Status last verified
- Dec 2020
- First submitted
- 1 Jul 2015
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
French KM, Gonzalez SZ, Sherman SE, Link AR, Malik SZ, Tseng CH, Jumkhawala SA, Tejada B, White A, Ladapo JA. Financial IncEntives for Smoking TreAtment: protocol of the FIESTA trial and FIESTA Oral Microbiome Substudy. Trials. 2018 Nov 21;19(1):646. doi: 10.1186/s13063-018-3003-y.
PubMed 30463608
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Effectiveness Trial Of Financial Incentives Versus Usual Care For Smokers Hospitalized In The Veterans Affairs Hospital System
- ClinicalTrials.gov ID
- NCT02506829
- Acronym / sponsor ID
- FIESTA / 72426
- Conditions
- Smoking, Smoking, Tobacco, Tobacco Use Disorder
- Keywords
- Inpatients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, University of California, Los Angeles
- Study start
- Jul 2015 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Behavioral: Smoking cessation counseling (Quitline), Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)Usual care in hospital, referral to a smoking cessation Quitline on discharge from hospital. |
| Financial Incentives | Experimental | Behavioral: Smoking cessation counseling (Quitline), Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy), Behavioral: Financial incentivesUsual 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation counseling (Quitline) | Behavioural | Financial Incentives, Usual care |
| Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy) | Behavioural | Financial Incentives, Usual care |
| Financial incentives | Behavioural | Financial Incentives |
Primary outcome
Smoking abstinence assessed by self-reported and biochemically verified by salivary cotinine
Time frame: 6 months
Assessed by self-report questionnaire, and biochemically verified by salivary cotinine
5 secondary outcomes
Smoking abstinence assessed by self-report
Time frame: 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
Time frame: 2 weeks and 2 months
Quality of life as measured by the EQ5-D and VR-12
Time frame: 6 months
Short term return on investment of using financial incentives to promote smoking cessation (Cost analysis)
Time frame: 12 months
Long term return on investment of using financial incentives to promote smoking cessation (Cost analysis)
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Derived from this study: PubMed 30463608French KM, Gonzalez SZ, Sherman SE, Link AR, Malik SZ, Tseng CH, Jumkhawala SA, Tejada B, White A, Ladapo JA. Financial IncEntives for Smoking TreAtment: protocol of the FIESTA trial and FIESTA Oral Microbiome Substudy. Trials. 2018 Nov 21;19(1):646. doi: 10.1186/s13063-018-3003-y.
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Ladapo, MD, PhD principal investigator
University of California, Los Angeles
Scott Sherman, MD, MPH principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation counseling (Quitline), Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy) and Financial incentives in people with Smoking and Smoking, Tobacco, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking abstinence assessed by self-reported and biochemically verified by salivary cotinine (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02506829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.