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临床试验/NCT01737281
NCT01737281已完成不适用

Proactive Outreach for Smokers in VA Mental Health

VA Office of Research and Development7 个研究点 分布在 1 个国家目标入组 1,938 人开始时间: 2014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
1,938
试验地点
7
主要终点
Number of Participants With Cotinine-Validated Abstinence From Smoking

研究概览

简要总结

Veterans with a mental health diagnosis have higher a prevalence of smoking and higher rates of smoking-related morbidities compared to the general Veteran population. Smoking cessation treatment delivery in the VA typically depends on a visit from a health care provider. In this study, investigators will use information within the electronic medical record to identify all smokers with a mental health diagnosis at a VA health care facility and proactively reach out to enroll them in an intensive tobacco cessation treatment program. This approach could be generalized to other behaviors and provides a novel method to improve the health of an entire population of patients.

详细描述

Background:

Tobacco use is the leading preventable cause of death in the United States and contributes up to 24% of all VA healthcare costs. Veterans enrolled in the VA healthcare system smoke substantially more than the general population, which is particularly true among Veterans diagnosed with mental illness. Patients with bipolar disorder or schizophrenia have the highest smoking rates (69% and 58-90%, respectively) followed by those with PTSD (45-63%) and depression (31-51%). Numerous barriers exist for tobacco cessation among mental health patients, including high nicotine dependency, low rates of follow through for referrals, and limited availability of tobacco treatment tailored to their needs.

Rationale:

Most medical care providers assess tobacco use and advise smokers to quit, but they have insufficient time to follow up with treatment, leading to low long-term quit rates. Mental health providers who often meet regularly with patients report that they find tobacco cessation outside the scope of their practice and neither assess tobacco use nor refer smokers for treatment. These practice patterns have been very difficult to change even with intensive methods and across various settings and provider types. Therefore, the investigators here propose to use the electronic medical record system to identify smokers receiving mental health care and proactively reach out to engage them in treatment in line with the following aims:

Specific Aims:

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

入选标准

  • Current smoker (i.e., any tobacco use in past 30 days)
  • Seen in VA Mental Health Clinic in prior 12 months

排除标准

  • Does not speak English
  • Does not have a telephone and mailing address (necessary to mail out consent materials and to deliver the telephone-based intervention)

研究组 & 干预措施

Proactive outreach

Experimental

Proactive outreach to deliver 7 sessions of telephone counseling and nicotine replacement therapy.

干预措施: Proactive outreach (Behavioral)

Usual care

Active Comparator

Usual smoking cessation care from clinical staff

干预措施: Usual care (Behavioral)

结局指标

主要结局

Number of Participants With Cotinine-Validated Abstinence From Smoking

时间窗: 12 months

The primary outcome will be cotinine-validated abstinence from smoking at 12-month follow-up.

次要结局

  • Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes(12 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (7)

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