Trial document




drksid header

  DRKS00016719

Trial Description

start of 1:1-Block title

Title

Digital communication assistance tool for non-German-speaking patients in prehospital emergency care

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

Trial Acronym

DICTUM-Rescue

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

URL of the Trial

http://www.dictum-rescue.de

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

Brief Summary in Lay Language

Being able to communicate one’s needs to medical personnel is essential for any medical treatment. Providing medical is therefore especially challenging, when patients who speak little or no German are confronted with only German-speaking medical staff, especially when no eligible interpreters are available.
With 'DICTUM Rescue' we would like to provide a smartphone-based application which helps paramedical staff to overcome language barriers with their non-German speaking patients. We cooperate with several Ambulance Services, which provide preclinical emergency care in Eastern Lower Saxony. The study is carried out by the Department of General Practice of the University Medical Center Göttingen together with the Malteser in Lower Saxony and the technical development partner aidminutes GmbH. Network partners are the District of Helmstedt and the City of Brunswig as well as the Interdisciplinary Emergency Department of the University Medical Center Göttingen. The project in rural areas is funded by the Federal Ministry of Food and Agriculture on the basis of a resolution of the German Parliament (Bundestag). The executing agency of the project is the Federal Office for Agriculture and Food (BLE) as part of a Federal Programme for Rural Development. Testing and further development in the urban areas is financed by the Lower Saxony Ministry for Social Affairs, Health and Equal Opportunities with funds from the European Social Fund (ESF) in line with the directive on grants to promote measures within the framework of the "Social Innovation" programme. The latter project is co-financed by Malteser Hilfsdienst gGmbH, aidminutes GmbH and the Department of General Practice, University Medical Center Göttingen.

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

Brief Summary in Scientific Language

Being able to communicate about acute symptoms and pre-existing conditions is the basis of any medical treatment. Situations of mutual incomprehension are therefore a great challenge for patients who do speak hardly or no German and the medical staff who treat them, especially when no suitable interpreters are available.
In the project 'DICTUM Rescue' we would like to improve these situations by using a newly developed smartphone-based communication assistance tool for preclinical emergency care. This tool is intended to support the paramedical staff in communicating with their non-German-speaking patients and thus overcome language barriers. The centrepiece of the application will be module for rapid anamnesis, which helps to collect necessary information. Questions and possible answers of the intervention are also presented image-, video- and audiobased, which includes also patients who are not familiar with writing. An action research approach is used to take the complex situations of prehospital emergency care as well as the needs of paramedical staff into account. The latter are involved in the whole development process. After establishing a stable useful version, the intervention is used and evaluated within a clinical study. The clinical study is designed as an open interventional, non-randomized study with two control groups and has a pilot character. The primary outcome is the improvement of communication in situations with language barriers. Secondary outcome is the improvement of information collection from patients with language barriers in emergency situations (number and quality of information). Exploratively, demands for supporting emergency physicians, on-scene intervals, presence of lay-interpreters, usage of the interventions with event sourcing are also observed. By recording clinical parameters, the analysis can be carried out taking into account the severity of the health restrictions. All data is collected anonymously. Patient recruitment takes place in two phases: In the first phase, patients of control group I (non-German-speaking patients who do not use the communication aid) and control group II (German-speaking patients who do not use the communication aid) are recruited. In the following second study phase the communication aid is usable, intervention patients and control group II patients are recruited.

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

Organizational Data

  •   DRKS00016719
  •   2019/02/08
  •   [---]*
  •   yes
  •   Approved
  •   9/9/18, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   emergeny care
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Interventional Group: Patients who speak one of the available languages and who use the digital communication assistance tool.
  •   Control Group I: Non-German speaking patients, who do not use the digital communication assistance tool
  •   Control Group II: German-speaking patients, who do not use the digital communication assistance tool
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Other
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

What: Improving the communication with non-German speaking patients in emergency situations
What exactly? The communication with patients in prehospital emergency care is considered to be improved when the intervention is used.
When: 02-19 to 12-19 Control stage (recruitment of control groups I and II), 01-20 to 06-20 Intervention stage (recruitment of intervention group and control group II)
How: Feedback from paramedical staff on paper questionnaires for each emergency drive

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

Secondary Outcome

What: Improving the collection of information from patients with language barriers in emergency situations (number and quality of information)
When: 02-19 to 12-19 Control stage (recruitment of control groups I and II), 01-20 to 06-20 Intervention stage (recruitment of intervention group and control group II)
How?: All relevant medical information for an emergency operation is documented, by default, on standardised DIVI rescue service protocols. The documentation is done digitally. The free text field for "Anamnesis, emergency events" will be analysed for both case and control patients.
What exactly? Statistical evaluation of DIVI rescue service protocols of intervention and control groups. Exploratively, demands for supporting emergency physicians, on-scene intervals, presence of lay-interpreters, usage of the interventions with event sourcing are also observed. By recording clinical parameters, the analysis can be carried out taking into account the severity of the health restrictions. All data is collected anonymously.

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

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2019/02/15
  •   5000
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

all patients cared for by the Malteser Ambulance Services in Königslutter am Elm, Wendhausen and Braunschweig as well as the ambulance service of the district of Helmstedt

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

Exclusion Criteria

Patients who do not speak any of the languages/dialects offered can only participate in the control group I.

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Allgemeinmedizin Universitätsmedizin Göttingen
    • Ms.  Prof. Dr.  Eva  Hummers 
    • Humboldtallee 38
    • 37073  Göttingen
    • 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
    • Institut für Allgemeinmedizin Universitätsmedizin Göttingen
    • Mr.  Frank  Müller 
    • Humboldtallee 38
    • 37073  Göttingen
    • 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
    • Institut für Allgemeinmedizin Universitätsmedizin Göttingen
    • Mr.  Frank  Müller 
    • Humboldtallee 38
    • 37073  Göttingen
    • 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
    • Bundesministerin für Ernährung und Landwirtschaft (BMEL)
    • 11055  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address materialSupport
    • Niedersächsisches Ministerium für Soziales, Gesundheit und Gleichstellung
    • Hannah-Arendt-Platz 2
    • 30159  Hannover
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    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.