Telemedical, Intersectoral Network as New Digital Health Structure to Measurably Improve the Local Health Care

NCT ID: NCT03137589

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 159065 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2020-01-31

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.

Detailed Description

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.

Conditions

Infection; Intensive Care Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control

Patients of this group are routinely treated without telemedical support.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Telemedical support

Patients of this group are routinely treated with telemedical support.

Group Type: ACTIVE_COMPARATOR

Telemedical support

Intervention Type: OTHER

Participating sites will be advised by telemedicine support.

Interventions

Telemedical support

Participating sites will be advised by telemedicine support.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gernot Marx, Univ.-Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

University Hospital Münster

Münster, , Germany

Countries

Germany

References

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Reference Type: BACKGROUND

PMID: 17323051 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 20628653 (View on PubMed)

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Reference Type: BACKGROUND

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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.

Reference Type: DERIVED

PMID: 35103604 (View on PubMed)

Related Links

https://www.aerzteblatt.de/archiv/175621/Klug-entscheiden-in-der-Infektiologie

Jung, N. Klug entscheiden: . . . in der Infektiologie. Dtsch Arztebl 2016; 113(13): A-608 / B-514 / C-510

Other Identifiers

16-162

Identifier Type: -

Identifier Source: org_study_id