Satellite-supplementation of Medical Outreach Clinics: a Feasibility Study
2014年5月8日 更新者:Bart M. Demaerschalk、Mayo Clinic
Much of the basic general medical care and chronic disease management in rural Honduras comes from groups of volunteers setting up temporary clinics run by volunteers.
These clinics, also known as brigades, or medical missions, are often criticized for their lack of quality and the lack of follow-up, both of which stem, in part, from understaffing with volunteer physicians.
This study is designed to assess if it is feasible, safe, and acceptable to treat patients in short-term mobile medical clinics in rural Honduras using US physicians connected with patients by videoconference.
研究概览
研究类型
介入性
注册 (实际的)
144
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Francisco Morazan
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Tegucigalpa、Francisco Morazan、洪都拉斯
- Global Brigades
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Able to give informed consent
- Non-emergent medical complaints
- At least 18 yrs in age
Exclusion Criteria:
- Pregnancy
- Mental Disability
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Telemedicine First
Patients whose first physician visit during the clinic was using videoconference, a form of telemedicine, and whose second physician visit during the clinic was with a physician in-person.
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Patients undergo a detailed history and examination to the degree that is possible using the videoconference program, skype, a digital camera for high-resolution images, and an electronic stethoscope.
A clinic volunteer aids with examination, translation and documentation.
其他名称:
Patients undergo a detailed history and examination by an in-person physician.
A clinic volunteer aids with examination, translation and documentation, as needed.
其他名称:
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实验性的:Telemedicine Second
Patients whose first physician visit during the clinic was with a physician in-person, and whose second physician visit during the clinic was using videoconference, a form of telemedicine.
This is the reverse order of visits of the "Telemedicine fist" arm.
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Patients undergo a detailed history and examination to the degree that is possible using the videoconference program, skype, a digital camera for high-resolution images, and an electronic stethoscope.
A clinic volunteer aids with examination, translation and documentation.
其他名称:
Patients undergo a detailed history and examination by an in-person physician.
A clinic volunteer aids with examination, translation and documentation, as needed.
其他名称:
|
有源比较器:Two physician visits
Patients who had two sequential visits with different in-person physicians.
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Patients undergo a detailed history and examination by an in-person physician.
A clinic volunteer aids with examination, translation and documentation, as needed.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Clinical Diagnoses
大体时间:Same Day as clinic visit (less than 6 hours)
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The diagnoses resulting from the two physician visits will be compared and a cohen's kappa statistic will be calculated for diagnoses between the visits.
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Same Day as clinic visit (less than 6 hours)
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Recommended clinical treatments
大体时间:Same Day as clinic visit (less than 6 hours)
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After each of a patient's two physician visits, the physician's resulting recommended treatments will be gathered for comparison between the two visits.
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Same Day as clinic visit (less than 6 hours)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Patient opinions of physician interactions
大体时间:Immediately following physician interactions (less than 6 hours)
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Patients will receive a survey following each interaction with a doctor.
These surveys cover communication, comfort and satisfaction.
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Immediately following physician interactions (less than 6 hours)
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Physician opinions of patient interactions
大体时间:immediately following volunteer activities with the clinic (less than 48 hours)
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doctors will fill out a survey about their patient interactions after they complete their experience volunteering with the clinic.
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immediately following volunteer activities with the clinic (less than 48 hours)
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Volunteer opinions of physician-patient interactions
大体时间:immediately following experience with the clinic (Less than 48 hours)
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Volunteers who helped with physician interactions will receive a survey about their experience concerning physician patient communication, volunteer educational value and perceived value of the experience.
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immediately following experience with the clinic (Less than 48 hours)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Cost
大体时间:One year (from pilot to completion of study)
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The costs of materials and services required to conduct the patient examinations will be collected to build an economic model and projected cost of scaling up the videoconference interventions.
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One year (from pilot to completion of study)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员:Bart Demaerschalk, MD/MSc、Mayo Clinic
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年2月1日
初级完成 (实际的)
2013年6月1日
研究完成 (实际的)
2013年6月1日
研究注册日期
首次提交
2013年3月20日
首先提交符合 QC 标准的
2013年3月26日
首次发布 (估计)
2013年3月29日
研究记录更新
最后更新发布 (估计)
2014年5月12日
上次提交的符合 QC 标准的更新
2014年5月8日
最后验证
2014年5月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 13-000132
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.