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临床试验/NCT00679861
NCT00679861Unknown2 期

Different Types of Proactive Smoking Interventions for General Medical Practices: An Implementation Study

University Medicine Greifswald0 个研究点目标入组 3,215 人开始时间: 2004年10月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
3,215
主要终点
Number of treated Patients by practice within study period

研究概览

简要总结

Primary care physicians can play an important role in reducing tobacco smoking in the population. The general practice is a suitable setting for implementing proactive smoking interventions, because a large proportion of the population can be regularly reached in a favorable psychological state. Further, a trustful interpersonal relationship between the practitioners and their patients is supposed to increase the susceptibility to preventive measures. However, currently general practitioners are not capitalizing this advantage although evidence based treatments are available, which are effective and cost-effective. Outreach programs combining educational and practice-based measures have been found to be effective in engaging practitioners in screening and in giving advice. Computer expert-system and brief counseling interventions, which are based on the Transtheo-retical Model of behavior change (TTM), are promising approaches for the entire population of practitioners and smoking patients. For large scale implementation, data are needed about the degree of integration in every day routine clinical practice that could be achieved by implementing such interventions. Objectives: Evaluating different strategies for the implementation of proactive smoking interventions in general practices. Methods: In a randomized controlled trial, 150 randomly selected general practices of a defined German region will be included. The procedure comprises the implementation of 1) an on-site computer expert-system intervention, 2) a counseling intervention provided by the practitioner, or 3) the computer expert-system plus the counseling intervention. During an implementation phase of one month, two on site training sessions and support by phone will be provided. Routine use of the interventions will be monitored for the following 6 months. Main outcome measures are the number and rate of identified and treated smokers. A follow-up assessment will be realized 12 months after practice attendance to determine the smoking status of the treated smokers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
Double (Care Provider, 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

入选标准

  • Practices with regular office hours
  • Practices predominantly providing primary medical care for adults
  • Patients with age 18 and older
  • Patients with sufficient German language and cognitive capabilities to complete assessment
  • Patients smoking within the preceding six month

排除标准

  • Practices planing closure within the next 12 months
  • Practices opening less than 12 months ago

结局指标

主要结局

Number of treated Patients by practice within study period

时间窗: 7 months

Point prevalence smoking abstinence of treated patients

时间窗: 24 hours, 7 days, 4 weeks, 6 months preceeding the 12 months follow-up assessment

次要结局

  • Stages of change progress(at 12 month follow-up compared to baseline)
  • Participation rate of practices(within recruitment phase)
  • Quit and cut down attempts of patients(12 months)
  • number of cigarettes smoked per day(4 weeks preceeding follow-up)

研究者

发起方
University Medicine Greifswald
申办方类型
Other

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