跳至主要内容
临床试验/NCT01414036
NCT01414036已完成不适用

Primary Care-based Patient Navigation to Promote Smoking Cessation Treatment: a Pilot Randomized Controlled Trial

Boston University0 个研究点目标入组 47 人开始时间: 2011年10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
47
主要终点
Engagement in Smoking Cessation Treatment

研究概览

简要总结

Cigarette smoking is a highly significant health threat, responsible for more than 430,000 deaths each year. Low-income persons and racial/ethnic minorities are at particularly high risk, smoking at greater rates and having greater tobacco-related morbidity and mortality than other persons. Yet poor and minority smokers are less likely to receive advice to stop smoking or to use tobacco cessation services. Using non-physician members of the health care team as patient navigators to connect low-income and minority smokers to evidence-based tobacco treatment services is a promising approach because 1) many primary care providers (PCPs) are unable to provide counseling to patients who smoke due to time constraints; 2) minority patients may be less aware of smoking cessation resources and may have misconceptions about tobacco dependence treatments; and 3) as primary care practices are redesigned as medical homes, non-physician members of the health care team will increasingly be taking on tasks previously performed by PCPs. Patient navigators are lay persons from the community, working as paid employees, who are trained to guide patients through the health care system to receive services. Information on the efficacy of patient navigation to connect vulnerable patients to smoking cessation services is needed.

The investigators will implement a patient navigation-based intervention in the primary care setting to promote engagement of low-income and minority patients in smoking cessation treatment. To test our intervention, the investigators will conduct a pilot randomized control trial (RCT), randomizing 240 patients to the intervention condition (patient navigation) or an enhanced traditional care (ETC) control condition. The investigators will perform follow-up at three months following the start of the intervention, with a primary outcome of engagement in smoking cessation treatment.

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
否

入选标准

  • •age > 18 years
  • •smoked cigarettes in the past week
  • •have a scheduled visit with a PCP
  • •telephone access
  • •English speaking
  • •able and willing to participate in the study protocol and provide informed consent.

排除标准

  • •planning to move out of the area within the next 6 months
  • •cognitive impairments that preclude participation in study activities.
  • •severe illness or distress
  • •inability to read/understand English
  • •actively using evidence-based smoking cessation treatment, and
  • •transient residence or lack of a telephone for follow-up assessments.

研究组 & 干预措施

Enhanced Traditional Care control

Active Comparator

This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.

干预措施: Enhanced Traditional Care control (Other)

Patient Navigation

Experimental

Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.

干预措施: Patient navigation (Behavioral)

结局指标

主要结局

Engagement in Smoking Cessation Treatment

时间窗: 3 months

This is a dichotomous variable, Y/N, based on a) completion of \> 1 quit line counseling session (based on self-report) OR b) \> 1 PCP visit in which smoking cessation treatment is discussed (patient self-report and medical record review of progress notes) OR c) Completion of \> 1 session of a BMC smoking cessation group (medical record review).

次要结局

  • Stage of Change With Regard to Smoking Cessation(3 months)
  • Use of Other Tobacco Treatment Support(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen E. Lasser

Physician

Boston University

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