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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infection, Intensive Care Patients

Intervention / Treatment
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* Other: Telemedical support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Stepped-Wedge-Design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients of this group are routinely treated without telemedical support. | |
| Active Comparator: Telemedical support<br>Patients of this group are routinely treated with telemedical support. | Other: Telemedical support<br>* Participating sites will be advised by telemedicine support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of sepsis diagnosis | Rate of sepsis diagnosis | through study completion, an average of 30 days up to a maximum of 1 year | 
| Rate of ARDS Diagnosis | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | Sepsis mortality rate | through study completion, an average of 30 days up to a maximum of 1 year | 
| Hospital mortality rate | 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 | 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 | Hospital stay measured in days | At discharge from Hospital; after an average of 30 days up to a maximum of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine