search
Back to results

Financial Incentives for Smoking Treatment (FIESTA)

Primary Purpose

Smoking, Smoking, Tobacco, Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smoking cessation counseling (Quitline)
Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)
Financial incentives
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking focused on measuring Inpatients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual care

Financial Incentives

Arm Description

Usual care in hospital, referral to a smoking cessation Quitline on discharge from hospital.

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).

Outcomes

Primary Outcome Measures

Smoking abstinence assessed by self-reported and biochemically verified by salivary cotinine
Assessed by self-report questionnaire, and biochemically verified by salivary cotinine

Secondary Outcome Measures

Smoking abstinence assessed by self-report
Assessed by self-report questionnaire
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
Quality of life as measured by the EQ5-D and VR-12
As measured by the EQ5-D and VR-12
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
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

Full Information

First Posted
July 1, 2015
Last Updated
December 9, 2020
Sponsor
NYU Langone Health
Collaborators
Robert Wood Johnson Foundation, University of California, Los Angeles
search

1. Study Identification

Unique Protocol Identification Number
NCT02506829
Brief Title
Financial Incentives for Smoking Treatment
Acronym
FIESTA
Official Title
A Randomized Comparative Effectiveness Trial Of Financial Incentives Versus Usual Care For Smokers Hospitalized In The Veterans Affairs Hospital System
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
March 5, 2019 (Actual)
Study Completion Date
May 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Robert Wood Johnson Foundation, University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Smoking, Tobacco, Tobacco Use Disorder
Keywords
Inpatients

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care in hospital, referral to a smoking cessation Quitline on discharge from hospital.
Arm Title
Financial Incentives
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Smoking cessation counseling (Quitline)
Intervention Type
Behavioral
Intervention Name(s)
Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)
Intervention Type
Behavioral
Intervention Name(s)
Financial incentives
Primary Outcome Measure Information:
Title
Smoking abstinence assessed by self-reported and biochemically verified by salivary cotinine
Description
Assessed by self-report questionnaire, and biochemically verified by salivary cotinine
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Smoking abstinence assessed by self-report
Description
Assessed by self-report questionnaire
Time Frame
6 months
Title
Use of evidence based treatment (e.g. counseling and smoking cessation medications) assessed by discharge prescriptions, Quitline records, receipts, letters and/or self-report
Description
Assessed by discharge prescriptions, Quitline records, receipts, letters and/or self-report
Time Frame
2 weeks and 2 months
Title
Quality of life as measured by the EQ5-D and VR-12
Description
As measured by the EQ5-D and VR-12
Time Frame
6 months
Title
Short term return on investment of using financial incentives to promote smoking cessation (Cost analysis)
Description
Cost analysis involving hospital utilization data, electronic health records and patient-reported healthcare utilization
Time Frame
12 months
Title
Long term return on investment of using financial incentives to promote smoking cessation (Cost analysis)
Description
Cost analysis involving hospital utilization data, electronic health records and patient-reported healthcare utilization
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Ladapo, MD, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Sherman, MD, MPH
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30463608
Citation
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.
Results Reference
derived

Learn more about this trial

Financial Incentives for Smoking Treatment

We'll reach out to this number within 24 hrs