Clinical trial NCT03137589: Telemedical, Intersectoral Network as New Digital Health Structure to Measurably Improve the Local Health Care
Official title: Telemedical, Intersectoral Network as New Digital Health Structure to Measurably Improve the Local Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Intensive Care Patients
Keywords: Telemedicine
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 159065
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped-Wedge-Design
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Improvement of treatment quality
timeFrame: through study completion, an average of 30 days up to a maximum of 1 year
Secondary outcomes:
measure: Rate of sepsis diagnosis
timeFrame: through study completion, an average of 30 days up to a maximum of 1 year
measure: Rate of ARDS Diagnosis
timeFrame: through study completion, an average of 30 days up to a maximum of 1 year
measure: Sepsis therapy in compliance with guidelines
timeFrame: through study completion, an average of 30 days up to a maximum of 1 year
measure: Rate of ARDS therapy according to guidelines
timeFrame: through study completion, an average of 30 days up to a maximum of 1 year
measure: Rate of inadequate antibiotic therapies
timeFrame: through study completion, an average of 30 days up to a maximum of 1 year
measure: Rate of patients with dialysis
timeFrame: At discharge from Intensive Care Unit (study completion); after an average of 30 days up to a maximum of 1 year
measure: Rate of transfer transport
timeFrame: At discharge from Intensive Care Unit (study completion); after an average of 30 days up to a maximum of 1 year
measure: Health-related quality of life (SF36-Questionnaire)
timeFrame: 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
measure: Rate of non-diagnosed sepsis
timeFrame: through study completion, an average of 30 days up to a maximum of 1 year
measure: Sepsis mortality rate
timeFrame: through study completion, an average of 30 days up to a maximum of 1 year
measure: Hospital mortality rate
timeFrame: through study completion, an average of 30 days up to a maximum of 1 year
measure: Length of stay in intensive care unit
timeFrame: At discharge from Intensive Care Unit (study completion); after an average of 30 days up to a maximum of 1 year
measure: Hospital stay
timeFrame: At discharge from Hospital; after an average of 30 days up to a maximum of 1 year
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital RWTH Aachen
state: NRW
city: Münster
country: Germany
facility: University Hospital Münster
Study officials:
affiliation: Clinic for Operative Intensive Care and Intermediate Care, University Hospital RWTH Aachen
name: Gernot Marx, Univ.-Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.