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Completed

NCT Number: NCT02506829

Financial Incentives for Smoking Treatment

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.

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Key information

Conditions

Smoking Behavior Chemically-Induced Disorders Mental Disorders Smoking, Tobacco Substance-Related Disorders Tobacco Smoking Tobacco Use Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smoking cessation counseling (Quitline)

Behavioral

Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)

Behavioral

Financial Incentives

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Robert Wood Johnson Foundation
  • University of California, Los Angeles

Registry information

Official study title

A Randomized Comparative Effectiveness Trial Of Financial Incentives Versus Usual Care For Smokers Hospitalized In The Veterans Affairs Hospital System

Acronym: FIESTA

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2015
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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