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Clinical Trials/NCT01363245
NCT01363245
Completed
Not Applicable

Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients.

NYU Langone Health2 sites in 1 country1,618 target enrollmentJuly 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Smoking Cessation
Sponsor
NYU Langone Health
Enrollment
1618
Locations
2
Primary Endpoint
Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The investigators plan to compare the effectiveness and cost effectiveness of an inpatient smoking cessation intervention for all smokers hospitalized at two urban public hospitals.

Detailed Description

Our sites are: Bellevue Hospital Center (a New York City public hospital) and the Manhattan campus of the VA New York Harbor Healthcare System. During hospitalization, all smokers will receive usual care. At the time of discharge, patients will be randomized to one of two arms: multisession telephone counseling by their hospital's smoking cessation staff, or faxed referral to the state Quitline (which will then perform phone outreach as per Quitline protocol). All patients enrolled in the study will receive nicotine replacement therapy. The primary aims are: Aim 1: To compare the effectiveness of the intervention (proactive multisession telephone counseling by in-hospital staff) versus control ('fax-to-quit' Quitline referral). Aim 2: To evaluate and compare the cost-effectiveness of these interventions from a societal perspective and from a payer perspective. The secondary aims are: Secondary Aim 1: To compare outcomes by race/ethnicity, immigrant status, inpatient diagnosis, and location of patient hospitalization Secondary Aim 2: To compare outcomes of the interventions at 6 and 12 months post-discharge Secondary Aim 3: To compare biochemically-verified abstinence rates at 6 months post-discharge Secondary Aim 4: To compare cessation outcomes between those who are known HIV-seropositive and those who are not, and explore possible mediators of cessation in HIV-seropositive patients

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
April 2015
Last Updated
10 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 phone number
  • provide consent in English, Spanish or Mandarin

Exclusion Criteria

  • Patients will be excluded if they use only smokeless tobacco or products such as betel (since there is not yet efficacy data for treating use of these tobacco products in the inpatient setting)
  • are pregnant or breastfeeding
  • are discharged to an institution (e.g. jail/prison, nursing home, long-term psychiatric facility).

Outcomes

Primary Outcomes

Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study

Time Frame: 4 yrs

To compare the effectiveness of a phone counseling intervention (proactive multisession telephone counseling by in-hospital staff) versus control intervention ('fax-to-quit' Quitline referral)

Secondary Outcomes

  • Cost Effectiveness comparison of two smoking cessation interventions.(4 yrs)
  • Comparison of cessation rates at 6 and 12 months post-discharge(4yrs)
  • Comparison of biochemically-verified smoking cessation(4 years)
  • Comparison of cessation outcomes by sociodemographic subgroups(4yrs)
  • Comparison of cessation outcomes between participants who are HIV-seropositive vs. those who are not(2 years)

Study Sites (2)

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