Telemedical, Intersectoral Network as New Digital Health Structure to Measurably Improve the Local Health Care (TELnet@NRW)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Münster、ドイツ
- University Hospital Münster
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NRW
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Aachen、NRW、ドイツ、52074
- University Hospital RWTH Aachen
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Control
Patients of this group are routinely treated without telemedical support.
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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Improvement of treatment quality
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Rate of sepsis diagnosis
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Gernot Marx, Univ.-Prof. Dr. med.、Clinic for Operative Intensive Care and Intermediate Care, University Hospital RWTH Aachen
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 16-162
個々の参加者データ (IPD) の計画
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Telemedical supportの臨床試験
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University of Wisconsin, MadisonAgency for Healthcare Research and Quality (AHRQ)募集
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Medical University of South CarolinaNational Center for Advancing Translational Sciences (NCATS)完了
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UConn HealthUniversity of Texas at Austin; Oregon Social Learning Center招待による登録
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University of HawaiiNational Institute on Minority Health and Health Disparities (NIMHD)完了
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Dana-Farber Cancer Institute引きこもった
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University of CalgaryAlberta Health services; University of Alberta; Covenant Health完了
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Women's College HospitalRyerson University引きこもった
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Columbia UniversityNational Institute of Nursing Research (NINR); Brigham and Women's Hospital完了