Trial document




drksid header

  DRKS00013067

Trial Description

start of 1:1-Block title

Title

ANNOTeM (acute neurological care in North-East Germany with telemedical support).
Effects of telemedicine-supported emergency care for acute neurological diseases

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ANNOTeM

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

https://www.charite.de/service/pressemitteilung/artikel/detail/telemedizinische_networking_improves_supply_neurological_emergencies/

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Objective: Neurological acute illnesses often lead to death or permanent disability. For these diseases, there are reliable prognosis-enhancing therapies available, which are often not sufficiently available in structurally weak regions or are only used late. ANNOTeM aims to improve the treatment quality of acute neurological emergencies in the north-eastern German states of Brandenburg and Mecklenburg-Western Pomerania.
Methodological approach: ANNOTeM describes a telemedicine network in which neurological centres cooperate with regional clinics and emergency services. By providing teleneurological counselling, setting up specialised neuroacute units, optimising emergency transfers and implementing consistent quality management, care will be improved at several levels. The application of telemedicine is consistently extended beyond stroke to other neurological acute diseases such as meningitis, cross-sectional syndromes or epileptic seizures.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Acute neurological syndromes are excellently suited for telemedically supported care. Since neurological symptoms such as paralysis, speech and consciousness disorders can be examined audiovisually well, an assisted clinical evaluation via video conference is reliably possible. In addition, essential instrumental examinations such as cerebral imaging by CT or MRI can be easily transferred by means of teleradiology. Laboratory data or neurophysiological findings such as the electroencephalogram (EEG) can also be transmitted digitally and allow a rapid and reliable assessment of the clinical situation/diagnosis from a distance. For these reasons, stroke care has become one of the most common telemedicine applications. Extensive analyses have shown that patient treatment in the TeleStroke concept leads to a more frequent, correct and safe use of thrombolysis therapy and that treatment in clinics with tele-stroke units is associated with significantly better process and treatment outcomes compared to hospitals without adequate facilities. Since this optimisation of care has also proved to be beneficial from a health economic point of view, telemedical treatment management was quickly included in the revenue-relevant procedure definitions of in-patient stroke treatment.
The consistent extension of the telemedical care concept to other acute neurological diseases, including the extension of the telemedical transmission of EEG information, planned in ANNOTeM is a worldwide novelty. In addition to the increased demands on the telemedical expertise in cooperation with the field of neuroradiology, this expansion requires increased interdisciplinary cooperation with the specialist areas of anaesthesia, intensive care medicine and neurosurgery. This ensures that patients with a broad spectrum of life-threatening or long-term quality of life impairing diseases have access to local care while at the same time being connected to highly specialised facilities. Telemedical networking and cross-network quality management ensure optimized cooperation across the various stages of hospital care, both in terms of organization and processes. The accelerated indication and transport organisation for secondary relocations to specialised clinics leads to an improved treatment offer for patients in structurally weak areas.
Through the implementation of the project, we expect an immediate improvement in the quality of treatment according to the current medical guidelines with a rapid impact on measurable patient-oriented outcomes such as mortality, need for care, in-patient re-admission rate and quality of life. The project aims to evaluate whether the concept of broad acute neurological telemedicine care leads to an improvement in the quality of processes and outcomes in the clinics being cared for. In addition, the concept is evaluated both as a whole and with regard to individual diagnoses in terms of the health economic balance.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00013067
  •   2017/11/16
  •   [---]*
  •   yes
  •   Approved
  •   EA4/188/17, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1202-4149 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I60 -  Subarachnoid haemorrhage
  •   I61 -  Intracerebral haemorrhage
  •   I62 -  Other nontraumatic intracranial haemorrhage
  •   I63 -  Cerebral infarction
  •   I64 -  Stroke, not specified as haemorrhage or infarction
  •   S06 -  Intracranial injury
  •   S07 -  Crushing injury of head
  •   S14 -  Injury of nerves and spinal cord at neck level
  •   S24 -  Injury of nerves and spinal cord at thorax level
  •   S34 -  Injury of nerves and lumbar spinal cord at abdomen, lower back and pelvis level
  •   G82 -  Paraplegia and tetraplegia
  •   G00 -  Bacterial meningitis, not elsewhere classified
  •   G01 -  Meningitis in bacterial diseases classified elsewhere
  •   G02 -  Meningitis in other infectious and parasitic diseases classified elsewhere
  •   G03 -  Meningitis due to other and unspecified causes
  •   G06 -  Intracranial and intraspinal abscess and granuloma
  •   G07 -  Intracranial and intraspinal abscess and granuloma in diseases classified elsewhere
  •   G41 -  Status epilepticus
  •   R40 -  Somnolence, stupor and coma
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Telemedicine-supported care model with sustainable strengthening of regional structures by implementation of Acute-Neuro-Units, standardised procedures, continuous further training.
  •   Conventional patient care before introduction of ANNOTeM
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Health care system
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Time to death or first-time care at home or paid care support for the first time within 90 days after the index event

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Extended observation period to 120 days;
Subgroup analyses for the events death, home care and first-time reimbursed care support;
Subgroup analyses for stroke

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/11/16
  •   2250
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Control group:
All patients of the health insurance companies AOK Nordost, BARMER und Techniker Krankenkasse, who have defined primary diagnoses (stroke: ICD-10: I60, I61, I62, I63, I64; head trauma: ICD-10: S06, S07; acute spinal cord injury ICD-10: S14, S24, S34, G82; Bacterial or viral meningitis/encephalitis, ICD-10: A39.0-2, A85-87, G00-G03, G06, G07; unclear disturbance of consciousness and status epilepticus: ICD-10: G41, R40) were included in participating clinics during the control period November 2014 through November 2016.

Intervention group:
All patients of the health insurance funds AOK Nordost, BARMER und Techniker Krankenkasse who have been admitted to the participating clinics with defined main diagnoses (see above) in the project period October (at some clinics December 2017 up to and including February 2020.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

non-acute syndromes (>24h), non-neurological syndromes

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité Universitätsmedizin Berlin
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Charité Universitätsmedizin Berlin
    • Mr.  Professor  Heinrich  Audebert 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Charité Universitätsmedizin Berlin
    • Mr.  Doktor  Joachim  Weber 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Gemeinsamer BundesausschussInnovationsausschuss
    • Wegelystrasse 8
    • 10623  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   +49 22838211120
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.