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
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 GöttingenProf. Dr. Eva HummersHumboldtallee 3837073 GöttingenGermany
- 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 GöttingenFrank MüllerHumboldtallee 3837073 GöttingenGermany
- 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 GöttingenFrank MüllerHumboldtallee 3837073 GöttingenGermany
- 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 GöttingenFrank MüllerHumboldtallee 3837073 GöttingenGermany
- 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 GleichstellungHannah-Arendt-Platz 230159 HannoverGermany
- 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 BerlinGermany
- 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 GöttingenVon-Siebold-Straße 337075 GöttingenGermany
- 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
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