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

1. juni 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

159065

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Control
Patients of this group are routinely treated without telemedical support.
Aktiv komparator: Telemedical support
Patients of this group are routinely treated with telemedical support.
Annen: Telemedical support
Participating sites will be advised by telemedicine support.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Improvement of treatment quality
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rate of sepsis diagnosis
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

RWTH Aachen University

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2017

Primær fullføring (Faktiske)

31. oktober 2019

Studiet fullført (Faktiske)

31. januar 2020

Datoer for studieregistrering

Først innsendt

28. april 2017

Først innsendt som oppfylte QC-kriteriene

28. april 2017

Først lagt ut (Faktiske)

3. mai 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juni 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2020

Sist bekreftet

1. januar 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 16-162

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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