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Financial IncEntives for Smoking TreAtment: protocol of the FIESTA trial and FIESTA Oral Microbiome Substudy.
Trials. 2018 Nov 21; 19(1):646.T

Abstract

BACKGROUND

Smoking is the leading preventable cause of death in the United States, but evidence-based smoking cessation therapy is underutilized. Financial incentive strategies represent an innovative approach for increasing the use of counseling and pharmacotherapy. If effective, they could supplement or supplant resource-intensive policy options, particularly in populations for whom smoking has substantial societal costs. FIESTA (Financial IncEntives for Smoking TreAtment) will randomize hospitalized smokers to receive usual smoking cessation care alone or usual smoking care augmented with financial incentives. We aim to compare the impact of these two strategies on 1) smoking abstinence, 2) use of counseling and nicotine replacement therapy, and 3) quality of life of participants. We also will evaluate the short-term and long-term return on the investment of incentives. The FIESTA Oral Microbiome Substudy will compare the oral microbiome of smokers and nonsmokers to longitudinally assess whether smoking cessation changes oral microbiome composition.

METHODS

We will enroll 182 inpatient participants from the Manhattan campus of the Veterans Affairs New York Harbor Healthcare System. All participants receive enhanced usual care, including screening for tobacco use, counseling while hospitalized, access to nicotine replacement therapy, and referral to a state Quitline. Patients in the financial incentive arm receive enhanced usual care and up to $550 for participating in the New York Smoker's Quitline, using nicotine replacement therapy (NRT), and achieving biochemically confirmed smoking cessation at 2 months and 6 months. In the microbiome substudy, we enroll nonsmoking control participants matched to each recruited smoker's hospital ward, sex, age, diabetes status, and antibiotic use. After discharge, participants are asked to complete periodic phone interviews at 2 weeks, 2 months, 6 months, and 12 months and provide expired carbon monoxide and saliva samples at 2 months, 6 months, and 12 months for cotinine testing and oral microbiome analysis.

DISCUSSION

The incentive interventions of FIESTA may benefit hospitalized smokers, an objective made all the more critical because smoking rates among hospitalized patients are higher than those in the general population. Moreover, the focus of FIESTA on evidence-based therapy and bioconfirmed smoking cessation can help guide policy efforts to reduce smoking-related healthcare costs in populations with high rates of tobacco use and costly illnesses.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT02506829 . Registered on 1 July 2014.

Authors+Show Affiliations

Department of Population Health, New York University School of Medicine, 227 East 30th Street, New York, NY, 10016, USA.Department of Population Health, New York University School of Medicine, 227 East 30th Street, New York, NY, 10016, USA.Department of Population Health, New York University School of Medicine, 227 East 30th Street, New York, NY, 10016, USA. Department of Medicine, VA New York Harbor Healthcare System, 423 East 23rd Street, New York, NY, 10010, USA. Department of Medicine, New York University School of Medicine, 560 First Avenue, New York, NY, 10016, USA.Department of Population Health, New York University School of Medicine, 227 East 30th Street, New York, NY, 10016, USA.Department of Population Health, New York University School of Medicine, 227 East 30th Street, New York, NY, 10016, USA.Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at UCLA, 10833 Le Conte Avenue, Los Angeles, CA, 90095, USA.Tufts University School of Medicine, 145 Harrison Avenue, Boston, MA, 02111, USA.New York Medical College, 40 Sunshine Cottage Road, Valhalla, NY, 10595, USA.SUNY Downstate Medical Center College of Medicine, 450 Clarkson Ave, Brooklyn, NY, 11203, USA.Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at UCLA, 10833 Le Conte Avenue, Los Angeles, CA, 90095, USA. jladapo@mednet.ucla.edu. Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at UCLA, 911 Broxton Ave., Los Angeles, CA, 90024, USA. jladapo@mednet.ucla.edu.

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

30463608

Citation

French, Katherine M., et al. "Financial IncEntives for Smoking TreAtment: Protocol of the FIESTA Trial and FIESTA Oral Microbiome Substudy." Trials, vol. 19, no. 1, 2018, p. 646.
French KM, Gonzalez SZ, Sherman SE, et al. Financial IncEntives for Smoking TreAtment: protocol of the FIESTA trial and FIESTA Oral Microbiome Substudy. Trials. 2018;19(1):646.
French, K. M., Gonzalez, S. Z., Sherman, S. E., Link, A. R., Malik, S. Z., Tseng, C. H., Jumkhawala, S. A., Tejada, B., White, A., & Ladapo, J. A. (2018). Financial IncEntives for Smoking TreAtment: protocol of the FIESTA trial and FIESTA Oral Microbiome Substudy. Trials, 19(1), 646. https://doi.org/10.1186/s13063-018-3003-y
French KM, et al. Financial IncEntives for Smoking TreAtment: Protocol of the FIESTA Trial and FIESTA Oral Microbiome Substudy. Trials. 2018 Nov 21;19(1):646. PubMed PMID: 30463608.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Financial IncEntives for Smoking TreAtment: protocol of the FIESTA trial and FIESTA Oral Microbiome Substudy. AU - French,Katherine M, AU - Gonzalez,Sasha Z, AU - Sherman,Scott E, AU - Link,Alissa R, AU - Malik,Sadozai Zoe, AU - Tseng,Chi-Hong, AU - Jumkhawala,Saahil A, AU - Tejada,Briesny, AU - White,Andrew, AU - Ladapo,Joseph A, Y1 - 2018/11/21/ PY - 2018/06/04/received PY - 2018/10/19/accepted PY - 2018/11/23/entrez PY - 2018/11/23/pubmed PY - 2019/3/15/medline KW - FIESTA KW - Financial incentives KW - Manhattan VA Hospital KW - Smoking cessation KW - Veterans SP - 646 EP - 646 JF - Trials JO - Trials VL - 19 IS - 1 N2 - BACKGROUND: Smoking is the leading preventable cause of death in the United States, but evidence-based smoking cessation therapy is underutilized. Financial incentive strategies represent an innovative approach for increasing the use of counseling and pharmacotherapy. If effective, they could supplement or supplant resource-intensive policy options, particularly in populations for whom smoking has substantial societal costs. FIESTA (Financial IncEntives for Smoking TreAtment) will randomize hospitalized smokers to receive usual smoking cessation care alone or usual smoking care augmented with financial incentives. We aim to compare the impact of these two strategies on 1) smoking abstinence, 2) use of counseling and nicotine replacement therapy, and 3) quality of life of participants. We also will evaluate the short-term and long-term return on the investment of incentives. The FIESTA Oral Microbiome Substudy will compare the oral microbiome of smokers and nonsmokers to longitudinally assess whether smoking cessation changes oral microbiome composition. METHODS: We will enroll 182 inpatient participants from the Manhattan campus of the Veterans Affairs New York Harbor Healthcare System. All participants receive enhanced usual care, including screening for tobacco use, counseling while hospitalized, access to nicotine replacement therapy, and referral to a state Quitline. Patients in the financial incentive arm receive enhanced usual care and up to $550 for participating in the New York Smoker's Quitline, using nicotine replacement therapy (NRT), and achieving biochemically confirmed smoking cessation at 2 months and 6 months. In the microbiome substudy, we enroll nonsmoking control participants matched to each recruited smoker's hospital ward, sex, age, diabetes status, and antibiotic use. After discharge, participants are asked to complete periodic phone interviews at 2 weeks, 2 months, 6 months, and 12 months and provide expired carbon monoxide and saliva samples at 2 months, 6 months, and 12 months for cotinine testing and oral microbiome analysis. DISCUSSION: The incentive interventions of FIESTA may benefit hospitalized smokers, an objective made all the more critical because smoking rates among hospitalized patients are higher than those in the general population. Moreover, the focus of FIESTA on evidence-based therapy and bioconfirmed smoking cessation can help guide policy efforts to reduce smoking-related healthcare costs in populations with high rates of tobacco use and costly illnesses. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02506829 . Registered on 1 July 2014. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/30463608/Financial_IncEntives_for_Smoking_TreAtment:_protocol_of_the_FIESTA_trial_and_FIESTA_Oral_Microbiome_Substudy_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-3003-y DB - PRIME DP - Unbound Medicine ER -