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临床试验/NCT00384254
NCT00384254已完成2 期

Tobacco Quitlines as an Adjunct to Dental Office Tobacco Intervention

Oregon Research Institute2 个研究点 分布在 1 个国家目标入组 2,177 人开始时间: 2004年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
2,177
试验地点
2
主要终点
The primary outcome is self-reported consecutive quit at 3 and 12 months following intervention.

研究概览

简要总结

The purpose of the study is to compare two methods for providing brief dental office-based interventions designed to help patients quit either cigarette smoking or smokeless tobacco use, and to compare these two dental office-based interventions with usual care. This trial will evaluate the effectiveness of a unique combination of dental office intervention plus referral to the telephone help line, both of which have been demonstrated to be effective interventions for tobacco cessation. The integration of two lines of research-dental office interventions and telephone help line effectiveness-led us to propose this clinical trial as a more efficient and disseminable model of both training and practice.

详细描述

Although many dental practitioners now routinely incorporate the first two of the "5A's" (Ask and Advise) into their practice, and previous research indicates that brief office-based interventions are effective in producing modest tobacco quit rates for dental patients, dental practitioners continue to perceive a number of obstacles to routine provision of tobacco cessation services. Many dental practitioners still believe that counseling patients to quit an addictive behavior is beyond the scope of their training or comfort.

Recent studies have shown that proactive phone counseling from State-sponsored telephone tobacco help lines has a positive effect on tobacco cessation. The use of these help lines offers a unique supplement to the dental professional that could reduce the burden on practitioner and enhance the likelihood of their patients' quitting. Referral to a specialist is within the common heuristic followed by dental and medical practitioners. Therefore, we believe referral to a telephone help line may be an innovative way of enabling dentists and dental hygienists to encourage and support their patients to quit tobacco.

We will test two levels of intervention as compared to usual care in a randomized clinical trial in which 60 dental practices in Mississippi are randomized to one of three conditions. In one condition ("5A's"), the dental team will provide a brief office-based intervention that is modeled on the "5A's" advocated by the Clinical Practice Guideline. In the second condition ("3A's" + THL), the dental team will provide the first three "A's" (Ask, Advise, Assess), and then refer patients to the State-supported telephone help line for provision of the cessation counseling and follow-up support. In the third condition (Usual Care), volunteering practices will ask their patients only to complete our study surveys.

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

  • Adult tobacco-using dental patients, aged 18 and older who come in for a regularly scheduled visit to a dentist or dental hygienist participating in our study.
  • Dentists in private practice, employing at least one dental hygienist and one dental assistant.

排除标准

  • Dental patients under the age of 18

结局指标

主要结局

The primary outcome is self-reported consecutive quit at 3 and 12 months following intervention.

时间窗: 3 and 12 month

Secondary outcomes are reduction in use, number of quit attempts at 3 and 12 months, and increases in readiness to quit.

时间窗: 3 and 12 months

次要结局

  • Conduct an economic analysis to determine the incremental cost per quit of the two interventions.(12 month)
  • Examine predictors of patient outcomes and the interaction of these variables with intervention condition.(12 month)
  • Examine patients' report of practitioner protocol delivery at six weeks as a function of intervention condition.(6 week and 12 month)
  • Examine the mediating effect of patient report of protocol delivery on patient outcomes across conditions.(12 month)
  • Assess practitioner report of implementation (at 3 months) and maintenance (at 12 months) of the protocol.(3 and 12 month)
  • Assess the effect of the intervention condition on changes in self-reported attitudes of dentists, dental hygienists, and dental assistants.(3 and 12 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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