Clinical trial NCT02506829: Financial Incentives for Smoking Treatment
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
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Smoking, Tobacco
Tobacco Use Disorder
Keywords: Inpatients
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
name: University of California, Los Angeles
First posted: 2015-07-23
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Smoking abstinence assessed by self-reported and biochemically verified by salivary cotinine
timeFrame: 6 months
Secondary outcomes:
measure: Smoking abstinence assessed by self-report
timeFrame: 6 months
measure: Use of evidence based treatment (e.g. counseling and smoking cessation medications) assessed by discharge prescriptions, Quitline records, receipts, letters and/or self-report
timeFrame: 2 weeks and 2 months
measure: Quality of life as measured by the EQ5-D and VR-12
timeFrame: 6 months
measure: Short term return on investment of using financial incentives to promote smoking cessation (Cost analysis)
timeFrame: 12 months
measure: Long term return on investment of using financial incentives to promote smoking cessation (Cost analysis)
timeFrame: 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: University of California, Los Angeles
name: Joseph Ladapo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Scott Sherman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.