Financial Incentives for Smoking Treatment

NCT02506829 | Completed

• 1 other identifier: 72426
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Smoking, Tobacco; Tobacco Use Disorder

Keywords

Inpatients

Outcome Measures

Primary Outcomes (1)

• Smoking abstinence assessed by self-reported and biochemically verified by salivary cotinine

  Assessed by self-report questionnaire, and biochemically verified by salivary cotinine

  6 months

Secondary Outcomes (5)

• Smoking abstinence assessed by self-report

  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

  2 weeks and 2 months

• Quality of life as measured by the EQ5-D and VR-12

  6 months

• Short term return on investment of using financial incentives to promote smoking cessation (Cost analysis)

  12 months

• Long term return on investment of using financial incentives to promote smoking cessation (Cost analysis)

  3 years

Study Arms (2)

Usual care

ACTIVE COMPARATOR

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)

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).

Behavioral: Smoking cessation counseling (Quitline); Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy); Behavioral: Financial incentives

Interventions

Smoking cessation counseling (Quitline) BEHAVIORAL

Financial Incentives; Usual care

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

Financial Incentives; Usual care

Financial incentives BEHAVIORAL

Financial Incentives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Robert Wood Johnson Foundation: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 30463608 DERIVED

MeSH Terms

Conditions

Smoking; Tobacco Smoking; Tobacco Use Disorder

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Behavior; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Joseph Ladapo, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Scott Sherman, MD, MPH

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 23, 2015
• Study Start: July 1, 2015
• Primary Completion: March 5, 2019
• Study Completion: May 20, 2019
• Last Updated: December 11, 2020

Record last verified: 2020-12

Locations

US (1)