Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock - Technical Performance (Optimal@NRW)

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.

Study Overview

• Status: Recruiting
• Conditions: Emergencies
• Intervention / Treatment: Other: Telemedical support

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.

• Study Type: Interventional
• Enrollment (Anticipated): 3073
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jörg Christian Brokmann, PD Dr. med.; Phone Number: 0241 80 88421; Email: jbrokmann@ukaachen.de
• Study Contact Backup: Name: Optimal@NRW Project Team; Phone Number: 0241 80 38899; Email: optimal-nrw@ukaachen.de

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Recruiting
    • University Hospital RWTH Aachen
    • Contact: Jörg Christian Brokmann, PD Dr. med.; Phone Number: 0241 80 88421; Email: jbrokmann@ukaachen.de
    • Contact: Optimal@NRW Project Team; Phone Number: 0241 80 38899; Email: optimal-nrw@ukaachen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants in this group are routinely treated.
Active Comparator: Telemedical support; Participants in this group are routinely treated with additional telemedical support and the use of the early warning system.	Other: Telemedical support; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of non-realized teleconsultations by request	Number of non-realized teleconsultations by request	6 to 15 months depending on the cluster affiliation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of system crash while running a teleconsultation	Number of system crash while running a teleconsultation	6 to 15 months depending on the cluster affiliation
Number of incorrect data transmissions within the overall system	Number of incorrect data transmissions within the overall system	6 to 15 months depending on the cluster affiliation
Duration until the realization of a teleconsultation	Duration until the realization of a teleconsultation	6 to 15 months depending on the cluster affiliation
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.	6 to 15 months depending on the cluster affiliation
Data transmission rate requirement	Data transmission rate requirement	6 to 15 months depending on the cluster affiliation
Rate of complications of the early warning system in connection with telemedicine	Rate of complications of the early warning system in connection with telemedicine	6 to 15 months depending on the cluster affiliation
Performance of the early warning system	- Number of system errors and terminations	6 to 15 months depending on the cluster affiliation
Performance of the early warning system	- Number of alarms in the early warning system	6 to 15 months depending on the cluster affiliation
Performance of the early warning system	- Number of false alarms	6 to 15 months depending on the cluster affiliation
Performance of the early warning system	- time from early warning system alarm to teleconsultation/physician contact	6 to 15 months depending on the cluster affiliation
Performance of the early warning system	- consequences of an alarming early warning system	6 to 15 months depending on the cluster affiliation
Performance of the teleconsultation equipment	- Number of complications	6 to 15 months depending on the cluster affiliation
Performance of the teleconsultation equipment	- Number of disconnection error or failure of components	6 to 15 months depending on the cluster affiliation
Performance of the teleconsultation equipment	- consultation extent	6 to 15 months depending on the cluster affiliation
Performance of the teleconsultation equipment	- call duration	6 to 15 months depending on the cluster affiliation
Performance of the teleconsultation equipment	- devices used	6 to 15 months depending on the cluster affiliation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction survey	Questionnaires and interviews to survey satisfaction about the technical equipment in the project	24 months
Ethic survey	Questionnaires and interviews to clarify whether the technical equipment is seen as ethically appropriate	24 months
Acceptance survey	Questionnaires and interviews to survey acceptance about the technical equipment in the project	24 months
Usability survey	Questionnaires and interviews to survey the usability of the technical equipment	24 months

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Collaborators: Optimal@NRW Research Group
• Investigators: Principal Investigator: Jörg Christian Brokmann, PD Dr. med., Uniklinik RWTH Aachen

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Bundesärztekammer. Beschlussprotokoll des 121. Deutschen Ärztetages in Erfurt vom 08. bis 11.05.2018, Stand 08.06.2018.
• Eatock D. Demografischer Ausblick für die Europäische Union 2019.
• Fehr A, Lange C, Fuchs J, Neuhauser H, Schmitz R. Gesundheitsmonitoring und Gesundheitsindikatoren in Europa. Robert Koch-Institut, Epidemiologie und Gesundheitsberichterstattung; 2017.
• Jacobs K, Kuhlmey A, Greß S, Klauber J, Schwinger A. Pflege-Report 2018. Berlin, Heidelberg: Springer Berlin Heidelberg; 2018.
• Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen. Bedarfsgerechte Steuerung der Gesundheitsversorgung. Gutachten 2018.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: nursing home; telemedicine; emergency department; geriatric; acute care; early warning score
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 19-019-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No