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Telemedical, Intersectoral Network as New Digital Health Structure to Measurably Improve the Local Health Care (TELnet@NRW)

1 juin 2020 mis à jour par: RWTH Aachen University
Telemedicine allows providing expert know-ledge from specialized health centers to regional hospitals and practices. In this multicenter, prospective, non-interventional study hospitals and practices in NRW are supplied via a telematics platform with expertise 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 with infectious diseases or need for intensive care should be treated with telemedical support. The participating hospitals and practices are randomly distributed into four clusters. The clusters are supplied with telemedicine at different time points but all clusters start at the same time collecting data from patient cohorts of infectiology and intensive care (e.g. symptom, therapeutic progress and outcome). The collected data is 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. The aim is to improve the treatment quality in regional hospitals and practices of patients with serious and complex diseases and bring forward the application of telemedicine.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

159065

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
      • Münster, Allemagne
        • University Hospital Münster
    • NRW
      • Aachen, NRW, Allemagne, 52074
        • University Hospital RWTH Aachen

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Control
Patients of this group are routinely treated without telemedical support.
Comparateur actif: Telemedical support
Patients of this group are routinely treated with telemedical support.
Autre: Telemedical support
Participating sites will be advised by telemedicine support.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Improvement of treatment quality
Délai: through study completion, an average of 30 days up to a maximum of 1 year
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").
through study completion, an average of 30 days up to a maximum of 1 year

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Rate of sepsis diagnosis
Délai: through study completion, an average of 30 days up to a maximum of 1 year
Rate of sepsis diagnosis
through study completion, an average of 30 days up to a maximum of 1 year
Rate of ARDS Diagnosis
Délai: through study completion, an average of 30 days up to a maximum of 1 year
Rate of ARDS Diagnosis
through study completion, an average of 30 days up to a maximum of 1 year
Sepsis therapy in compliance with guidelines
Délai: through study completion, an average of 30 days up to a maximum of 1 year
Sepsis therapy in compliance with guidelines through for instance timely administration of antibiotics within 3 h and reduction of sepsis mortality.
through study completion, an average of 30 days up to a maximum of 1 year
Rate of ARDS therapy according to guidelines
Délai: through study completion, an average of 30 days up to a maximum of 1 year

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
Rate of inadequate antibiotic therapies
Délai: through study completion, an average of 30 days up to a maximum of 1 year
Measured by the Percentage of postoperatively continued perioperative Antibiotic prophylaxis
through study completion, an average of 30 days up to a maximum of 1 year
Rate of patients with dialysis
Délai: At discharge from Intensive Care Unit (study completion); after an average of 30 days up to a maximum of 1 year
Rate of patients with dialysis requiring Kidney insufficiency in discharge from the Intensive care
At discharge from Intensive Care Unit (study completion); after an average of 30 days up to a maximum of 1 year
Rate of transfer transport
Délai: At discharge from Intensive Care Unit (study completion); after an average of 30 days up to a maximum of 1 year
Rate of transfer transport
At discharge from Intensive Care Unit (study completion); after an average of 30 days up to a maximum of 1 year
Health-related quality of life (SF36-Questionnaire)
Délai: 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
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
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
Rate of non-diagnosed sepsis
Délai: through study completion, an average of 30 days up to a maximum of 1 year
Defined as no filled out sepsis bundle despite presence of sepsis symptoms
through study completion, an average of 30 days up to a maximum of 1 year
Sepsis mortality rate
Délai: through study completion, an average of 30 days up to a maximum of 1 year
Sepsis mortality rate
through study completion, an average of 30 days up to a maximum of 1 year
Hospital mortality rate
Délai: through study completion, an average of 30 days up to a maximum of 1 year
Hospital mortality rate
through study completion, an average of 30 days up to a maximum of 1 year
Length of stay in intensive care unit
Délai: At discharge from Intensive Care Unit (study completion); after an average of 30 days up to a maximum of 1 year
Length of stay in intensive care unit measured in hours
At discharge from Intensive Care Unit (study completion); after an average of 30 days up to a maximum of 1 year
Hospital stay
Délai: At discharge from Hospital; after an average of 30 days up to a maximum of 1 year
Hospital stay measured in days
At discharge from Hospital; after an average of 30 days up to a maximum of 1 year

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

RWTH Aachen University

Les enquêteurs

  • Chercheur principal: Gernot Marx, Univ.-Prof. Dr. med., Clinic for Operative Intensive Care and Intermediate Care, University Hospital RWTH Aachen

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mai 2017

Achèvement primaire (Réel)

31 octobre 2019

Achèvement de l'étude (Réel)

31 janvier 2020

Dates d'inscription aux études

Première soumission

28 avril 2017

Première soumission répondant aux critères de contrôle qualité

28 avril 2017

Première publication (Réel)

3 mai 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 juin 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juin 2020

Dernière vérification

1 janvier 2020

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 16-162

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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