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临床试验/NCT01363245
NCT01363245已完成不适用

Effectiveness of Smoking-cessation Interventions for Urban Hospital Patients.

NYU Langone Health2 个研究点 分布在 1 个国家目标入组 1,618 人开始时间: 2011年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,618
试验地点
2
主要终点
Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age ≥ 18 years
  • smoked tobacco during the prior 30 days
  • have an active phone number
  • provide consent in English, Spanish or Mandarin

排除标准

  • 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).

研究组 & 干预措施

Hospital phone counseling

Experimental

multisession telephone counseling by hospital/study's smoking cessation staff

干预措施: Telephone Counseling (Behavioral)

Fax-to-quit

Active Comparator

Faxed referral to the state Quitline, which will then perform phone outreach as per Quitline protocol

干预措施: Fax-to-quit (Behavioral)

结局指标

主要结局

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

时间窗: 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)

次要结局

  • Comparison of biochemically-verified smoking cessation(4 years)
  • Cost Effectiveness comparison of two smoking cessation interventions.(4 yrs)
  • 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)
  • Comparison of cessation rates at 6 and 12 months post-discharge(4yrs)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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