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Financial Incentives for Smoking Treatment (FIESTA)

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ClinicalTrials.gov Identifier: NCT02506829
Recruitment Status : Recruiting
First Posted : July 23, 2015
Last Update Posted : May 9, 2019
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
University of California, Los Angeles
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Smoking Smoking, Tobacco Tobacco Use Disorder Behavioral: Smoking cessation counseling (Quitline) Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy) Behavioral: Financial incentives Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Comparative Effectiveness Trial Of Financial Incentives Versus Usual Care For Smokers Hospitalized In The Veterans Affairs Hospital System
Actual Study Start Date : July 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Usual care
Usual care in hospital, referral to a smoking cessation Quitline on discharge from hospital.
Behavioral: Smoking cessation counseling (Quitline)
Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)
Experimental: Financial Incentives
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).
Behavioral: Smoking cessation counseling (Quitline)
Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)
Behavioral: Financial incentives



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Smoking abstinence assessed by self-report [ Time Frame: 6 months ]
    Assessed by self-report questionnaire

  2. 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 ]
    Assessed by discharge prescriptions, Quitline records, receipts, letters and/or self-report

  3. Quality of life as measured by the EQ5-D and VR-12 [ Time Frame: 6 months ]
    As measured by the EQ5-D and VR-12

  4. Short term return on investment of using financial incentives to promote smoking cessation (Cost analysis) [ Time Frame: 12 months ]
    Cost analysis involving hospital utilization data, electronic health records and patient-reported healthcare utilization

  5. Long term return on investment of using financial incentives to promote smoking cessation (Cost analysis) [ Time Frame: 3 years ]
    Cost analysis involving hospital utilization data, electronic health records and patient-reported healthcare utilization



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506829


Contacts
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Contact: Joseph Ladapo, MD, PhD 646-285-7397 JLadapo@mednet.ucla.edu
Contact: Scott Sherman, MD, MPH 646-285-7397 Scott.Sherman@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Katherine French    212-686-7500 ext 3015    Katherine.French@nyumc.org   
Contact: Sasha Gonzalez    212-686-7500 ext 3015    Sasha.Gonzalez@nyumc.org   
Sub-Investigator: Scott Sherman, MD         
Principal Investigator: Joseph Ladapo, MD         
Sponsors and Collaborators
NYU Langone Health
Robert Wood Johnson Foundation
University of California, Los Angeles
Investigators
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Principal Investigator: Joseph Ladapo, MD, PhD University of California, Los Angeles
Principal Investigator: Scott Sherman, MD, MPH NYU Langone Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02506829     History of Changes
Other Study ID Numbers: 72426
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Keywords provided by NYU Langone Health:
Inpatients
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action