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

Organizational Data

DRKS-ID:
DRKS00016719
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2019-02-08
Last update in DRKS:
2023-03-16
Registration type:
Prospective

Acronym/abbreviation of the study

DICTUM-Rescue

URL of the study

http://www.dictum-rescue.de

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.

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.

Health condition or problem studied

Free text:
emergeny care
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Interventional Group: Patients who speak one of the available languages and who use the digital communication assistance tool.
Arm 2:
Control Group I: Non-German speaking patients, who do not use the digital communication assistance tool
Arm 3:
Control Group II: German-speaking patients, who do not use the digital communication assistance tool

Endpoints

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
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.

Study Design

Purpose:
Other
Allocation:
Non-randomized controlled study
Control:
  • Control group receives no treatment
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Other
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Other Malteser Rettungswachen in Königslutter am Elm, Wendhausen und Braunschweig sowie Rettungswache des Landkreis Helmstedt Königslutter am Elm, Wendhausen, Helmstedt und Braunschweig

Recruitment period and number of participants

Planned study start date:
2019-02-15
Actual study start date:
2019-02-15
Planned study completion date:
2020-06-30
Actual Study Completion Date:
2021-11-15
Target Sample Size:
20000
Final Sample Size:
23179

Inclusion Criteria

Sex:
All
Minimum Age:
no minimum age
Maximum Age:
no maximum age
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

Exclusion Criteria

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

Addresses

Primary Sponsor

Address:
Institut für Allgemeinmedizin Universitätsmedizin Göttingen
Prof. Dr. Eva Hummers
Humboldtallee 38
37073 Göttingen
Germany
Telephone:
+49 (0) 551 39-22638
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.allgemeinmedizin.med.uni-goettingen.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Institut für Allgemeinmedizin Universitätsmedizin Göttingen
Frank Müller
Humboldtallee 38
37073 Göttingen
Germany
Telephone:
+49 (0)551-39 65663
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.allgemeinmedizin.med.uni-goettingen.de

Contact for Public Queries

Address:
Institut für Allgemeinmedizin Universitätsmedizin Göttingen
Frank Müller
Humboldtallee 38
37073 Göttingen
Germany
Telephone:
+49 (0)551-39 65663
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.allgemeinmedizin.med.uni-goettingen.de

Principal Investigator

Address:
Institut für Allgemeinmedizin Universitätsmedizin Göttingen
Frank Müller
Humboldtallee 38
37073 Göttingen
Germany
Telephone:
+49 (0)551-39 65663
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.allgemeinmedizin.med.uni-goettingen.de

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:
Niedersächsisches Ministerium für Soziales, Gesundheit und Gleichstellung
Hannah-Arendt-Platz 2
30159 Hannover
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:
Bundesministerin für Ernährung und Landwirtschaft (BMEL)
11055 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Address:
Ethikkommission der Universitätsmedizin Göttingen
Von-Siebold-Straße 3
37075 Göttingen
Germany
Telephone:
+49-551-3961261
Fax:
+49-551-3969536
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2018-08-20
Ethics committee number:
9/9/18
Vote of the Ethics Committee:
Approved
Date of the vote:
2018-10-26

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
Müller F, Hummers E, Noack EM. Medical Characteristics of Foreign Language Patients in Paramedic Care. Int J Environ Res Public Health. 2020 Aug 30;17(17):6306. doi: 10.3390/ijerph17176306. PMID: 32872563; PMCID: PMC7503963.
Müller F, Hummers E, Schulze J, Noack EM. Nutz- und Bedienbarkeit einer App zur Überwindung von Sprachbarrieren im Rettungsdienst [Usability of an app to overcome language barriers in paramedic care]. Notf Rett Med. 2022;25(8):570-577. German. doi: 10.1007/s10049-021-00913-w. Epub 2021 Jul 2. PMID: 34230808; PMCID: PMC8251687.
Müller F, Hummers E, Jablonka A, Schmidt T, Noack EM. Auswirkung des COVID-19-Lockdowns auf Rettungseinsätze [Impact of the COVID-19 lockdown on emergency medical service operations]. Notf Rett Med. 2022;25(5):341-347. German. doi: 10.1007/s10049-021-00873-1. Epub 2021 Apr 22. PMID: 33903799; PMCID: PMC8060906.
Noack EM, Schulze J, Müller F. Designing an App to Overcome Language Barriers in the Delivery of Emergency Medical Services: Participatory Development Process. JMIR Mhealth Uhealth. 2021 Apr 14;9(4):e21586. doi: 10.2196/21586. PMID: 33851933; PMCID: PMC8082383.
Noack EM, Kleinert E, Müller F. Overcoming language barriers in paramedic care: a study protocol of the interventional trial 'DICTUM rescue' evaluating an app designed to improve communication between paramedics and foreign-language patients. BMC Health Serv Res. 2020 Mar 18;20(1):223. doi: 10.1186/s12913-020-05098-5. PMID: 32183775; PMCID: PMC7079507.
Date of first publication of study results:
2020-08-30
DRKS entry published for the first time with results:
2023-03-16

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry