Clinical trial NCT04879537: Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock
Official title: Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergencies
Keywords: telemedicine
geriatric
early warning score
acute care
nursing home
emergency department
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: Optimal@NRW Research Group
First posted: 2021-05-10
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped-Wedge-Design
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Days spent at hospital
timeFrame: 24 months
measure: Number of Intervention-related adverse events
timeFrame: 6 to 15 months depending on the cluster affiliation
Secondary outcomes:
measure: Days spent at nursing home
timeFrame: 24 months
measure: Number of medical contacts
timeFrame: 24 months
measure: Time to doctor contact
timeFrame: 24 months
measure: Number of admissions to hospital
timeFrame: 24 months
measure: Amount of use of medical services
timeFrame: 24 months
measure: Number of ambulatory sensitive hospital cases
timeFrame: 24 months
measure: Cost effects via HCRU
timeFrame: 24 months
measure: Transport units used
timeFrame: 24 months
measure: Quality of Life - QOL-AD
timeFrame: 24 months
measure: Quality of Life - VR-12
timeFrame: 24 months
measure: Barthel Index
timeFrame: 24 months
measure: Dementia Screening Scale (DSS)
timeFrame: 24 months
measure: Number of double prescriptions
timeFrame: 24 months
measure: Number of hospitalizations due to medication
timeFrame: 24 months
measure: Number of adverse events due to medication
timeFrame: 24 months
measure: Time-to-event concerning medication and hospitalization
timeFrame: 24 months
measure: Need for additional staff in case of telemedical call
timeFrame: 24 months
measure: Amount of ambulance service calls
timeFrame: 24 months
measure: hospital referrals and use of primary care physicians and physicians of the GP emergency service before and after the implementation of telemedicine in nursing homes
timeFrame: 9 to 18 months depending on the cluster affiliation
measure: Response times in doctor-patient contact
timeFrame: 24 months
measure: Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital
timeFrame: 24 months
measure: Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital
timeFrame: 24 months
measure: Number of incorrect suspected diagnoses compared to diagnoses after teleconsultation or admission to hospital
timeFrame: 24 months
measure: Rate of guideline deviations in diagnostics and therapy for specific tracer diagnoses (e.g. hypertension/blood pressure derailment, blood sugar derailment, infections - community-acquired (urinary tract infection, bronchitis, pneumonia))
timeFrame: 24 months
measure: Evaluation of the processes, NÄPA (Z) operations and tele consultations
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Evaluation of the processes, NÄPA (Z) operations and tele consultations
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Evaluation of the processes, NÄPA (Z) operations and tele consultations
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Evaluation of the processes, NÄPA (Z) operations and tele consultations
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Evaluation of the processes, NÄPA (Z) operations and tele consultations
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Evaluation of the processes, NÄPA (Z) operations and tele consultations
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Evaluation of the processes, NÄPA (Z) operations and tele consultations
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Evaluation of the processes, NÄPA (Z) operations and tele consultations
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Evaluation of the processes, NÄPA (Z) operations and tele consultations
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Applicability of an early warning score in nursing homes
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Applicability of an early warning score in nursing homes
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Applicability of an early warning score in nursing homes
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Applicability of an early warning score in nursing homes
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Applicability of an early warning score in nursing homes
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Applicability of an early warning score in nursing homes
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Applicability of an early warning score in nursing homes
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Applicability of an early warning score in nursing homes
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Applicability of an early warning score in nursing homes
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Rate of applicability of an early warning score in nursing homes
timeFrame: 6 to 15 months depending on the cluster affiliation
measure: Gender differences
timeFrame: 24 months
Other outcomes:
measure: Satisfaction survey
timeFrame: 24 months
measure: Satisfaction survey
timeFrame: 24 months
measure: Ethic survey
timeFrame: 24 months
measure: Ethic survey
timeFrame: 24 months
measure: Acceptance survey
timeFrame: 24 months
measure: Acceptance survey
timeFrame: 24 months
Locations:
city: Aachen
country: Germany
facility: University Hospital RWTH Aachen
Study officials:
affiliation: Uniklinik RWTH Aachen
name: Jörg Christian Brokmann, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: Bundesärztekammer. Beschlussprotokoll des 121. Deutschen Ärztetages in Erfurt vom 08. bis 11.05.2018, Stand 08.06.2018.
citation: Eatock D. Demografischer Ausblick für die Europäische Union 2019.
citation: Fehr A, Lange C, Fuchs J, Neuhauser H, Schmitz R. Gesundheitsmonitoring und Gesundheitsindikatoren in Europa. Robert Koch-Institut, Epidemiologie und Gesundheitsberichterstattung; 2017.
citation: Jacobs K, Kuhlmey A, Greß S, Klauber J, Schwinger A. Pflege-Report 2018. Berlin, Heidelberg: Springer Berlin Heidelberg; 2018.
citation: Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen. Bedarfsgerechte Steuerung der Gesundheitsversorgung. Gutachten 2018.
citation: Brucken D, Unterkofler J, Pauge S, Bienzeisler J, Hubel C, Zechbauer S, Rossaint R, Greiner W, Aufenberg B, Rohrig R, Bollheimer LC; Optimal@NRW Research Group; Brokmann JC. Optimal@NRW: optimized acute care of nursing home residents using an intersectoral telemedical cooperation network - study protocol for a stepped-wedge trial. Trials. 2022 Sep 27;23(1):814. doi: 10.1186/s13063-022-06613-1.