Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock - Technical Performance (Optimal@NRW)
Primary Purpose
Emergencies
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Telemedical support
Sponsored by
About this trial
This is an interventional other trial for Emergencies focused on measuring telemedicine, geriatric, early warning score, acute care, nursing home, emergency department
Eligibility Criteria
Inclusion Criteria:
- Resident of one of the participating nursing homes
- At least 18 years old
- Written informed consent
- Consent of the guardian for residents who are not legally able to give consent
Exclusion Criteria:
- Persons placed in an institution by order of an authority or court
- Persons who are in a dependent or employment relationship with the investigator
Sites / Locations
- University Hospital RWTH AachenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Telemedical support
Arm Description
Participants in this group are routinely treated.
Participants in this group are routinely treated with additional telemedical support and the use of the early warning system.
Outcomes
Primary Outcome Measures
Number of non-realized teleconsultations by request
Number of non-realized teleconsultations by request
Secondary Outcome Measures
Number of system crash while running a teleconsultation
Number of system crash while running a teleconsultation
Number of incorrect data transmissions within the overall system
Number of incorrect data transmissions within the overall system
Duration until the realization of a teleconsultation
Duration until the realization of a teleconsultation
Number of causes that lead to system crash
A system crash is defined as a failure of one of the following three components that cannot be recovered within 5 minutes: Audio connection, visual connection, transmission of vital signs.
Data transmission rate requirement
Data transmission rate requirement
Rate of complications of the early warning system in connection with telemedicine
Rate of complications of the early warning system in connection with telemedicine
Performance of the early warning system
- Number of system errors and terminations
Performance of the early warning system
- Number of alarms in the early warning system
Performance of the early warning system
- Number of false alarms
Performance of the early warning system
- time from early warning system alarm to teleconsultation/physician contact
Performance of the early warning system
- consequences of an alarming early warning system
Performance of the teleconsultation equipment
- Number of complications
Performance of the teleconsultation equipment
- Number of disconnection error or failure of components
Performance of the teleconsultation equipment
- consultation extent
Performance of the teleconsultation equipment
- call duration
Performance of the teleconsultation equipment
- devices used
Full Information
NCT ID
NCT04873973
First Posted
March 31, 2021
Last Updated
May 4, 2021
Sponsor
RWTH Aachen University
Collaborators
Optimal@NRW Research Group
1. Study Identification
Unique Protocol Identification Number
NCT04873973
Brief Title
Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock - Technical Performance
Acronym
Optimal@NRW
Official Title
Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock - Technical Performance
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RWTH Aachen University
Collaborators
Optimal@NRW Research Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Due to "demographic change", the composition of the population in Germany is changing. The consequence of this change is a population that is getting older on average. A key challenge is the appropriate nursing and medical care of older people in senior residences and care facilities. The increasing workload for nursing staff and doctors in the outpatient sector means that timely care for patients, e.g. in the form of GP visits, cannot always be guaranteed in a timely manner. The results are unnecessary or premature hospital admissions as well as ambulance and emergency care interventions, even though in many cases it is not an acute or even life-threatening event. Furthermore, it has been scientifically proven that hospital admissions can increase the risk of patients becoming confused. The aim of this project is to avoid unnecessary hospital admissions and to enable patients to remain in their familiar surroundings as far as this appears medically justifiable. At the same time, the study aims to improve the medical care of nursing home residents through better networking of medical areas, the use of tele-consultations and an early warning system.
Detailed Description
The Optimal@NRW project represents a new cross-sectoral approach to the acute care and support of geriatric people in need of care through the implementation of an early warning system and the integration of a telemedical consultation system in 25 nursing homes in the region of Aachen in Germany. The project focuses on restructuring emergency care in nursing homes and improving cooperation between the actors involved (emergency service, emergency department, general practitioners, nursing staff, etc.). Accordingly, a central emergency number of the statutory health insurance funds is to act as a virtual hub for the care of geriatric patients.
The concrete approach of the project is that the participating nursing homes first contact the medical call centre (116 117) in case of a medical problem. The call centre is then responsible for an initial medical assessment and decides whether the respective GP can be called in or whether a teleconsultation with the "virtual digital desk" (i.e. the medical experts from the emergency department of the University Hospital RWTH Aachen) should be carried out. In addition, mobile nursing assistants (NÄPÄ (Z)) will be introduced as part of the project, who can also support the nursing staff and provide services that can be delegated by doctors - especially if the general practitioner is not available at the time.
In addition, a standardised early warning system is to be established in the nursing homes and its benefits evaluated. This will enable potentially dangerous changes in the state of health of nursing home residents to be detected earlier.
The unique and novel development of the technical concept and the interaction between a central electronic patient record, an early warning system and the telemedical equipment plays a decisive role in the success of the project.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies
Keywords
telemedicine, geriatric, early warning score, acute care, nursing home, emergency department
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stepped-Wedge-Design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3073 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this group are routinely treated.
Arm Title
Telemedical support
Arm Type
Active Comparator
Arm Description
Participants in this group are routinely treated with additional telemedical support and the use of the early warning system.
Intervention Type
Other
Intervention Name(s)
Telemedical support
Intervention Description
The nursing homes participating in the project will be equipped with telemedical equipment. This will allow teleconsultations to take place when needed. In addition, an early warning system will be introduced and, within the framework of the teleconsultation, a trained medical assistant can be sent to the care facility if necessary, who can carry out medical activities on site under a physician's delegated instructions. In addition, an electronic patient file will be introduced which can be accessed by the telemedicine physician and the general practitioner.
Primary Outcome Measure Information:
Title
Number of non-realized teleconsultations by request
Description
Number of non-realized teleconsultations by request
Time Frame
6 to 15 months depending on the cluster affiliation
Secondary Outcome Measure Information:
Title
Number of system crash while running a teleconsultation
Description
Number of system crash while running a teleconsultation
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Number of incorrect data transmissions within the overall system
Description
Number of incorrect data transmissions within the overall system
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Duration until the realization of a teleconsultation
Description
Duration until the realization of a teleconsultation
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Number of causes that lead to system crash
Description
A system crash is defined as a failure of one of the following three components that cannot be recovered within 5 minutes: Audio connection, visual connection, transmission of vital signs.
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Data transmission rate requirement
Description
Data transmission rate requirement
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Rate of complications of the early warning system in connection with telemedicine
Description
Rate of complications of the early warning system in connection with telemedicine
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Performance of the early warning system
Description
- Number of system errors and terminations
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Performance of the early warning system
Description
- Number of alarms in the early warning system
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Performance of the early warning system
Description
- Number of false alarms
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Performance of the early warning system
Description
- time from early warning system alarm to teleconsultation/physician contact
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Performance of the early warning system
Description
- consequences of an alarming early warning system
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Performance of the teleconsultation equipment
Description
- Number of complications
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Performance of the teleconsultation equipment
Description
- Number of disconnection error or failure of components
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Performance of the teleconsultation equipment
Description
- consultation extent
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Performance of the teleconsultation equipment
Description
- call duration
Time Frame
6 to 15 months depending on the cluster affiliation
Title
Performance of the teleconsultation equipment
Description
- devices used
Time Frame
6 to 15 months depending on the cluster affiliation
Other Pre-specified Outcome Measures:
Title
Satisfaction survey
Description
Questionnaires and interviews to survey satisfaction about the technical equipment in the project
Time Frame
24 months
Title
Ethic survey
Description
Questionnaires and interviews to clarify whether the technical equipment is seen as ethically appropriate
Time Frame
24 months
Title
Acceptance survey
Description
Questionnaires and interviews to survey acceptance about the technical equipment in the project
Time Frame
24 months
Title
Usability survey
Description
Questionnaires and interviews to survey the usability of the technical equipment
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Resident of one of the participating nursing homes
At least 18 years old
Written informed consent
Consent of the guardian for residents who are not legally able to give consent
Exclusion Criteria:
Persons placed in an institution by order of an authority or court
Persons who are in a dependent or employment relationship with the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jörg Christian Brokmann, PD Dr. med.
Phone
0241 80 88421
Email
jbrokmann@ukaachen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Optimal@NRW Project Team
Phone
0241 80 38899
Email
optimal-nrw@ukaachen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jörg Christian Brokmann, PD Dr. med.
Organizational Affiliation
Uniklinik RWTH Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jörg Christian Brokmann, PD Dr. med.
Phone
0241 80 88421
Email
jbrokmann@ukaachen.de
First Name & Middle Initial & Last Name & Degree
Optimal@NRW Project Team
Phone
0241 80 38899
Email
optimal-nrw@ukaachen.de
12. IPD Sharing Statement
Citations:
PubMed Identifier
17092344
Citation
Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006 Nov 8;6:54. doi: 10.1186/1471-2288-6-54.
Results Reference
background
PubMed Identifier
25662947
Citation
Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015 Feb 6;350:h391. doi: 10.1136/bmj.h391. No abstract available.
Results Reference
background
PubMed Identifier
28103927
Citation
Hoffmann F, Schmiemann G. Influence of age and sex on hospitalization of nursing home residents: A cross-sectional study from Germany. BMC Health Serv Res. 2017 Jan 19;17(1):55. doi: 10.1186/s12913-017-2008-7.
Results Reference
background
PubMed Identifier
26428441
Citation
Sundmacher L, Fischbach D, Schuettig W, Naumann C, Augustin U, Faisst C. Which hospitalisations are ambulatory care-sensitive, to what degree, and how could the rates be reduced? Results of a group consensus study in Germany. Health Policy. 2015 Nov;119(11):1415-23. doi: 10.1016/j.healthpol.2015.08.007. Epub 2015 Sep 2.
Results Reference
background
PubMed Identifier
30226850
Citation
Vossius C, Selbaek G, Saltyte Benth J, Bergh S. Mortality in nursing home residents: A longitudinal study over three years. PLoS One. 2018 Sep 18;13(9):e0203480. doi: 10.1371/journal.pone.0203480. eCollection 2018.
Results Reference
background
Citation
Bundesärztekammer. Beschlussprotokoll des 121. Deutschen Ärztetages in Erfurt vom 08. bis 11.05.2018, Stand 08.06.2018.
Results Reference
background
Citation
Eatock D. Demografischer Ausblick für die Europäische Union 2019.
Results Reference
background
Citation
Fehr A, Lange C, Fuchs J, Neuhauser H, Schmitz R. Gesundheitsmonitoring und Gesundheitsindikatoren in Europa. Robert Koch-Institut, Epidemiologie und Gesundheitsberichterstattung; 2017.
Results Reference
background
Citation
Jacobs K, Kuhlmey A, Greß S, Klauber J, Schwinger A. Pflege-Report 2018. Berlin, Heidelberg: Springer Berlin Heidelberg; 2018.
Results Reference
background
Citation
Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen. Bedarfsgerechte Steuerung der Gesundheitsversorgung. Gutachten 2018.
Results Reference
background
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Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock - Technical Performance
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