跳至主要内容
临床试验/NCT01321944
NCT01321944已完成不适用

A POPULATION-BASED DIRECT-TO-SMOKER OUTREACH OFFERING TOBACCO TREATMENT IN A HEALTH CARE SETTING: A RANDOMIZED CONTROLLED TRIAL

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 590 人开始时间: 2009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
590
试验地点
1
主要终点
proportion of participants who reported using any tobacco dependence treatment during the 3-month study period

研究概览

简要总结

Tobacco use is the leading preventable cause of death in the United States. Effective treatment for tobacco dependence exists and includes counseling and pharmacotherapy with nicotine replacement, bupropion, or varenicline. The health care system is a key channel for delivering this treatment to smokers. Brief clinical interventions delivered at office visits increase smoking cessation rates, are among the most cost-effective of medical interventions, and are recommended by U.S. Public Health Service. However, physicians and other clinicians often fail to provide them. Clinicians' rates of providing tobacco treatment in ambulatory care can be improved, but even when successful, clinicians can only reach smokers who make an office visit.

A health care system might improve its delivery of tobacco treatment by supplementing visit-based efforts with a population-based strategy, using methods proven effective in public health settings. A population of smokers could be identified from electronic health records and offered treatment proactively in a way that maximizes convenience and minimizes barriers such the cost of pharmacotherapy. This study tests the effectiveness of a population-based Direct-to-Smoker (DTS) outreach program provided to smokers in one community health center in Revere, MA, that is part of an integrated health care system. It uses the system's population management tools to identify smokers and proactively offers them evidence-based tobacco treatment that is free and does require making an office visit. A randomized controlled trial will compare the effectiveness of the DTS program to usual primary care. The hypothesis is that adding the DTS program to usual primary care will increase the proportion of smokers who use tobacco dependence treatment and thereby stop smoking.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Adults (>= 18 years)
  • •made an office visit to a primary care physician (PCP) at Revere Health Center in the year prior to May 2009
  • •has a telephone
  • •listed as a smoker in the past 5 years in the electronic health record

排除标准

  • •severe psychiatric or neurologic diagnosis (e.g., psychosis, dementia) on problem list of electronic health record

研究组 & 干预措施

Usual clinical care

No Intervention

Usual clinical care provided by health care system

DTS intervention

Experimental

Intervention group participants will be sent 3 letters at monthly intervals signed by the participant's PCP that encourages the smoker to quit, and offers a free telephone consultation by Partners' Tobacco Treatment Coordinator (TTC), free nicotine patches, and referral to additional treatment resources including the state's free telephone quitline.

干预措施: Direct to Smoker Outreach Program (Other)

结局指标

主要结局

proportion of participants who reported using any tobacco dependence treatment during the 3-month study period

时间窗: 3 months

Tobacco dependence treatment is defined as (1) any smoking cessation counseling contact (with the Tobacco Treatment Coordinator, the Massachusetts Smokers Quitline, or in-person counseling) or (2) any FDA-approved smoking cessation pharmacotherapy (nicotine patch, gum, lozenge, inhaler, or nasal spray; bupropion; or varenicline).

次要结局

  • Use of smoking cessation counseling(Past 3 months)
  • 7-day point prevalence abstinence from tobacco products(3 month follow-up)
  • 30-day point prevalence abstinence from tobacco products(3 month follow-up)
  • Use of nicotine replacement therapy(Past 3 months)
  • Use of any tobacco cessation medication(Past 3 months)

研究者

申办方类型
Other

研究点 (1)

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