NCT03137589

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159,065

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

June 2, 2020

Status Verified

January 1, 2020

Enrollment Period

2.5 years

First QC Date

April 28, 2017

Last Update Submit

June 1, 2020

Conditions

InfectionIntensive Care Patients

Keywords

Telemedicine

Outcome Measures

Primary Outcomes (1)

  • Improvement of treatment quality

    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

Secondary Outcomes (13)

  • Rate of sepsis diagnosis

    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

    through study completion, an average of 30 days up to a maximum of 1 year

  • Rate of ARDS therapy according to guidelines

    through study completion, an average of 30 days up to a maximum of 1 year

  • Rate of inadequate antibiotic therapies

    through study completion, an average of 30 days up to a maximum of 1 year

  • +8 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Patients of this group are routinely treated without telemedical support.

Telemedical support

ACTIVE COMPARATOR

Patients of this group are routinely treated with telemedical support.

Other: Telemedical support

Interventions

Telemedical supportOTHER

Participating sites will be advised by telemedicine support.

Telemedical support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • majority
  • written informed consent
  • infectiological and/or intensive care treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

University Hospital Münster

Münster, Germany

Location

Related Publications (4)

  • 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.

    PMID: 17323051BACKGROUND

  • 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.

    PMID: 20628653BACKGROUND

  • 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/

    PMID: 21250349BACKGROUND

  • 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.

    PMID: 35103604DERIVED

Related Links

MeSH Terms

Conditions

Infections

Study Officials

  • Gernot Marx, Univ.-Prof. Dr. med.

    Clinic for Operative Intensive Care and Intermediate Care, University Hospital RWTH Aachen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Stepped-Wedge-Design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2017

First Posted

May 3, 2017

Study Start

May 1, 2017

Primary Completion

October 31, 2019

Study Completion

January 31, 2020

Last Updated

June 2, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)