Telemedical, Intersectoral Network as New Digital Health Structure to Measurably Improve the Local Health Care (TELnet@NRW)
研究概览
详细说明
In future time the number of old people will significantly increase in Germany because of the demographic change taking place. The health care of the large number of old people will probably lead to a lack of physicians and an inefficient health care system. One strategy to tackle the problem could be telemedicine. Telemedicine makes it possible to provide know-ledge from experts to local hospitals and practices which otherwise need to send patients with serious and complex diseases to specialized trans-regional health centers. In this multicenter, prospective, non-interventional study hospitals and practices in NRW are supplied via a telematics platform with expert know-ledge from the university hospitals RWTH Aachen and Münster. The communication occurs via highly encrypted audio/video conference systems and a certified data exchange platform "Fallakte+".
In total 40.000 outpatient and stationary patients should be treated with telemedical support. Registered doctors will be involved in already existing practice networks to evaluate the potential for transfer and to ensure the sharing of know-ledge beyond the borders of individual sectors. The aim of the study is to improve the treatment quality of regional hospitals and practices and to increase the efficiency of the care of relevant patient cohort in the field of infectiology and intensive care with the main focus sepsis as those patient groups especially often require professional expertise for a successful therapy.
In the beginning of the study participating hospitals and practices are randomly distributed into four clusters (cluster randomization). The different clusters all start with the control phase but enter into the intervention phase at different times (stepped-wedge design). During the control phase data of patients with infection and intensive care patients routinely treated without the support of telemedicine are documented and the patients are asked to complete a questionnaire regarding health-related quality of life (SF36) directly after treatment and at two time points in the follow-up. The collected data will be later compared to data obtained in the same way from patients treated with telemedical support and evaluated regarding differences in the quality of treatment, therapeutic process and the satisfaction of the patients with telemedicine.
If the study shows that the treatment quality and therapeutic process of patients with infectious diseases or need for intensive care is improved by telemedicine, the telematics platform can be expanded and used by other specialized fields and users in future time.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Münster、德国
- University Hospital Münster
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NRW
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Aachen、NRW、德国、52074
- University Hospital RWTH Aachen
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- majority
- written informed consent
- infectiological and/or intensive care treatment
Exclusion Criteria:
- minority
- absence of written informed consent in the case of non-acute life-threatening disease
- persons who have a dependency or employment relationship with the sponsor or investigator
- persons who are sheltered in an institution upon court or administrative order
学习计划
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Control
Patients of this group are routinely treated without telemedical support.
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有源比较器：Telemedical support
Patients of this group are routinely treated with telemedical support.
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Participating sites will be advised by telemedicine support.
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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 |
|---|---|---|
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Improvement of treatment quality
大体时间：through study completion, an average of 30 days up to a maximum of 1 year
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The level of implementation of the 10 recommendations of the German Society of Infectious Diseases (Deutsche Gesellschaft für Infektiologie, DGI) within the framework of the Initiative "Decide wisely" ("Klug entscheiden").
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through study completion, an average of 30 days up to a maximum of 1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rate of sepsis diagnosis
大体时间：through study completion, an average of 30 days up to a maximum of 1 year
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Rate of sepsis diagnosis
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through study completion, an average of 30 days up to a maximum of 1 year
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Rate of ARDS Diagnosis
大体时间：through study completion, an average of 30 days up to a maximum of 1 year
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Rate of ARDS Diagnosis
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through study completion, an average of 30 days up to a maximum of 1 year
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Sepsis therapy in compliance with guidelines
大体时间：through study completion, an average of 30 days up to a maximum of 1 year
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Sepsis therapy in compliance with guidelines through for instance timely administration of antibiotics within 3 h and reduction of sepsis mortality.
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through study completion, an average of 30 days up to a maximum of 1 year
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Rate of ARDS therapy according to guidelines
大体时间：through study completion, an average of 30 days up to a maximum of 1 year
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Measured against the evident ventilation targets, Ventilation with low ventilation volumes and low peak pressures: with controlled ventilation: Breath volume of 6 ml/kg calculated Body ideal weight, PEEP setting in proportion with the necessary FiO2, plateau pressure < 30 cm H2O |
through study completion, an average of 30 days up to a maximum of 1 year
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Rate of inadequate antibiotic therapies
大体时间：through study completion, an average of 30 days up to a maximum of 1 year
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Measured by the Percentage of postoperatively continued perioperative Antibiotic prophylaxis
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through study completion, an average of 30 days up to a maximum of 1 year
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Rate of patients with dialysis
大体时间：At discharge from Intensive Care Unit (study completion); after an average of 30 days up to a maximum of 1 year
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Rate of patients with dialysis requiring Kidney insufficiency in discharge from the Intensive care
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At discharge from Intensive Care Unit (study completion); after an average of 30 days up to a maximum of 1 year
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Rate of transfer transport
大体时间：At discharge from Intensive Care Unit (study completion); after an average of 30 days up to a maximum of 1 year
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Rate of transfer transport
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At discharge from Intensive Care Unit (study completion); after an average of 30 days up to a maximum of 1 year
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Health-related quality of life (SF36-Questionnaire)
大体时间：At discharge from Intensive Care Unit (through study completion; an average of 30 days up to a maximum of 1 year), through study completion, an average of 12 months and 24 months after discharge of ICU
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Clinical studies 36-item Medical Outcomes Study Short-Form General Health Survey An instrument used to assess multidimensional health-related QOL, which measures 8 health related parameters: physical function, social function, physical role, emotional role, mental health, energy, pain, general health perceptions; each parameter is scored from 0 to 100 Managed care 36-Item Short-Form Functional and Perceived Health Status Survey A questionnaire which measures health status; the SF-36 also includes a list of 18 self-reported chronic conditions
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At discharge from Intensive Care Unit (through study completion; an average of 30 days up to a maximum of 1 year), through study completion, an average of 12 months and 24 months after discharge of ICU
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Rate of non-diagnosed sepsis
大体时间：through study completion, an average of 30 days up to a maximum of 1 year
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Defined as no filled out sepsis bundle despite presence of sepsis symptoms
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through study completion, an average of 30 days up to a maximum of 1 year
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Sepsis mortality rate
大体时间：through study completion, an average of 30 days up to a maximum of 1 year
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Sepsis mortality rate
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through study completion, an average of 30 days up to a maximum of 1 year
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Hospital mortality rate
大体时间：through study completion, an average of 30 days up to a maximum of 1 year
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Hospital mortality rate
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through study completion, an average of 30 days up to a maximum of 1 year
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Length of stay in intensive care unit
大体时间：At discharge from Intensive Care Unit (study completion); after an average of 30 days up to a maximum of 1 year
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Length of stay in intensive care unit measured in hours
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At discharge from Intensive Care Unit (study completion); after an average of 30 days up to a maximum of 1 year
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Hospital stay
大体时间：At discharge from Hospital; after an average of 30 days up to a maximum of 1 year
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Hospital stay measured in days
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At discharge from Hospital; after an average of 30 days up to a maximum of 1 year
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合作者和调查者
调查人员
- 首席研究员：Gernot Marx, Univ.-Prof. Dr. med.、Clinic for Operative Intensive Care and Intermediate Care, University Hospital RWTH Aachen
出版物和有用的链接
一般刊物
- Engel C, Brunkhorst FM, Bone HG, Brunkhorst R, Gerlach H, Grond S, Gruendling M, Huhle G, Jaschinski U, John S, Mayer K, Oppert M, Olthoff D, Quintel M, Ragaller M, Rossaint R, Stuber F, Weiler N, Welte T, Bogatsch H, Hartog C, Loeffler M, Reinhart K. Epidemiology of sepsis in Germany: results from a national prospective multicenter study. Intensive Care Med. 2007 Apr;33(4):606-18. doi: 10.1007/s00134-006-0517-7. Epub 2007 Feb 24.
- Reinhart K, Brunkhorst FM, Bone HG, Bardutzky J, Dempfle CE, Forst H, Gastmeier P, Gerlach H, Grundling M, John S, Kern W, Kreymann G, Kruger W, Kujath P, Marggraf G, Martin J, Mayer K, Meier-Hellmann A, Oppert M, Putensen C, Quintel M, Ragaller M, Rossaint R, Seifert H, Spies C, Stuber F, Weiler N, Weimann A, Werdan K, Welte T; German Sepsis Society; German Interdisciplinary Association of Intensive Care and Emergency Medicine. Prevention, diagnosis, therapy and follow-up care of sepsis: 1st revision of S-2k guidelines of the German Sepsis Society (Deutsche Sepsis-Gesellschaft e.V. (DSG)) and the German Interdisciplinary Association of Intensive Care and Emergency Medicine (Deutsche Interdisziplinare Vereinigung fur Intensiv- und Notfallmedizin (DIVI)). Ger Med Sci. 2010 Jun 28;8:Doc14. doi: 10.3205/000103.
- Laxminarayan R, Bhutta Z, Duse A, Jenkins P, O'Brien T, Okeke IN, Pablo-Mendez A, Klugman KP. Drug Resistance. In: Jamison DT, Breman JG, Measham AR, Alleyne G, Claeson M, Evans DB, Jha P, Mills A, Musgrove P, editors. Disease Control Priorities in Developing Countries. 2nd edition. Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2006. Chapter 55. Available from http://www.ncbi.nlm.nih.gov/books/NBK11774/
- Marx G, Greiner W, Juhra C, Elkenkamp S, Gensorowsky D, Lemmen S, Englbrecht J, Dohmen S, Gottschalk A, Haverkamp M, Hempen A, Flugel-Bleienheuft C, Bause D, Schulze-Steinen H, Rademacher S, Kistermann J, Hoch S, Beckmann HJ, Lanckohr C, Lowitsch V, Peine A, Juzek-Kuepper F, Benstoem C, Sperling K, Deisz R. An Innovative Telemedical Network to Improve Infectious Disease Management in Critically Ill Patients and Outpatients (TELnet@NRW): Stepped-Wedge Cluster Randomized Controlled Trial. J Med Internet Res. 2022 Mar 2;24(3):e34098. doi: 10.2196/34098.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 16-162
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
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-
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