跳至主要内容
临床试验/NCT00112268
NCT00112268已完成3 期

Quitlink : A Leveraging Solution to Tobacco Counseling

Virginia Ambulatory Care Outcomes Research Network2 个研究点 分布在 1 个国家目标入组 3,200 人开始时间: 2005年6月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
3,200
试验地点
2
主要终点
Whether the intervention increases the proportion of tobacco users (age 18 and older) who receive help within the domains of A3-5 (Assess, Assist, and/or Arrange) at the index office visit, as reported by exiting patients

研究概览

简要总结

Primary: To test whether the delivery of A3-5 smoking cessation counseling (Assess, Assist, Arrange) in primary care offices is enhanced by a system that couples (1) an expanded vital sign intervention with (2) fax referral of preparation-stage patients for telephone counseling and (3) feedback to the provider. The question will be examined in a randomized trial, with practices as the unit of analysis and with a control intervention consisting of a conventional vital sign intervention. The experiment will therefore compare what intervention and control practices accomplish beyond simply identifying patients who use tobacco.

Secondary: To assess contextual factors that might affect implementation of the intervention and account for its ultimate success or failure. In particular, to assess: (1) environmental and practice-level factors that affect practices' ability to successfully implement and use the intervention and; (2) patient characteristics beyond readiness to change (i.e., age, gender, race/ethnicity) that affect willingness to use the quit line and complete counseling.

详细描述

Among the most important evidence-based interventions in primary care is to offer counseling and pharmacotherapy to patients who use tobacco, but studies suggest that only a fraction of tobacco users receive this assistance. Office systems and other strategies can improve counseling rates but are not widely adoptable in primary care. We propose a novel solution that couples a simple office system, which is widely adoptable, with a form of third-party counseling (telephone quit lines) that most practices can access in the United States. Specifically, the three-part intervention includes (1) an in-office expanded "vital signs" intervention that prompts nurses (or medical assistants) to determine tobacco use status, offer brief advice, and assess readiness to quit as vital signs are obtained; (2) inviting preparation-stage tobacco users to obtain proactive telephone counseling (provided by the American Cancer Society) comprising three 30-minute sessions scheduled at the patient's convenience; and (3) feedback from the Society to the practice, including fax requisitions for prescription aids for quit attempts, progress reports on the results of counseling, and quarterly aggregate analyses of practice and clinician team referral outcomes. The Virginia Ambulatory Care Outcomes Research Network will partner with the American Cancer Society to test this strategy in a randomized controlled trial conducted at 16 primary care practices in Virginia. Because existing dissemination strategies serve mainly to increase identification of tobacco users and sometimes to increase brief advice, our primary outcome measure will be the proportion of tobacco users who receive substantive assistance: Assess, Assist, and Arrange of the 5As. Given the widening availability of state and national quit line programs, our model for referrals and bidirectional communication with primary care could markedly augment the effectiveness of both primary care and quit lines in promoting tobacco cessation and provide an attractive alternative for clinicians who lack the time and resources to provide effective counseling.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Educational Counseling Training
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

入选标准

  • Current use of tobacco
  • Age 18 or older
  • Visit with a clinician that day
  • Patient at one of the 16 practices in the study

排除标准

  • Unable to participate in a self-administered exit survey

结局指标

主要结局

Whether the intervention increases the proportion of tobacco users (age 18 and older) who receive help within the domains of A3-5 (Assess, Assist, and/or Arrange) at the index office visit, as reported by exiting patients

次要结局

  • The frequency with which tobacco users are identified (Ask) and advised to quit (Advise)
  • The proportion of patients in the preparation stage who consent to telephone counseling
  • How recipients of A1-2, A3-5, and the offer of telephone counseling differ by age, gender, doctor seen, and reason for visit
  • The proportion of consenting patients who are contacted by American Cancer Society (ACS) counselors within 2 weeks of referral
  • The proportion who completed three counseling sessions

研究者

发起方
Virginia Ambulatory Care Outcomes Research Network
申办方类型
Other

研究点 (2)

Loading locations...

相似试验