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Clinical Trials/NCT02506829
NCT02506829
Completed
Not Applicable

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

NYU Langone Health1 site in 1 country182 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Smoking
Sponsor
NYU Langone Health
Enrollment
182
Locations
1
Primary Endpoint
Smoking abstinence assessed by self-reported and biochemically verified by salivary cotinine
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
May 20, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Long term return on investment of using financial incentives to promote smoking cessation (Cost analysis)(3 years)
  • Smoking abstinence assessed by self-report(6 months)
  • Short term return on investment of using financial incentives to promote smoking cessation (Cost analysis)(12 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)

Study Sites (1)

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