Optimized Acute Care for Geriatric Patients Using an Intersectoral Telemedical Cooperation Network - Around the Clock

NCT04879537 | Completed DMC

• 1 other identifier: 19-019
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergencies

Keywords

telemedicine; geriatric; early warning score; acute care; nursing home; emergency department

Outcome Measures

Primary Outcomes (2)

• Days spent at hospital

  Days spent at hospital

  24 months

• Number of Intervention-related adverse events

  * Resuscitation during teleconsultation * Unexpected death during teleconsultation * Unexpected death within 24 hours after teleconsultation * Unexpected hospitalisation within 24 hours of teleconsultation * Unexpected death while wearing a biosensor (if available)

  6 to 15 months depending on the cluster affiliation

Secondary Outcomes (44)

• Days spent at nursing home

  24 months

• Number of medical contacts

  24 months

• Time to doctor contact

  24 months

• Number of admissions to hospital

  24 months

• Amount of use of medical services

  24 months

Other Outcomes (6)

• Satisfaction survey

  24 months

• Satisfaction survey

  24 months

• Ethic survey

  24 months

Study Arms (2)

Control

NO INTERVENTION

Participants in this group are routinely treated.

Telemedical support

ACTIVE COMPARATOR

Participants in this group are routinely treated with additional telemedical support and the use of the early warning system.

Other: Telemedical support

Interventions

Telemedical support OTHER

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.

Telemedical support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Persons placed in an institution by order of an authority or court
• Persons who are in a dependent or employment relationship with the investigator

Sponsors & Collaborators

• RWTH Aachen University: lead
• Optimal@NRW Research Group: collaborator

Study Sites (1)

University Hospital RWTH Aachen

Aachen, 52074, Germany

Location

Related Publications (11)

• 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.

  PMID: 17092344 BACKGROUND

• 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.

  PMID: 25662947 BACKGROUND

• 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.

  PMID: 28103927 BACKGROUND

• 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.

  PMID: 26428441 BACKGROUND

• 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.

  PMID: 30226850 BACKGROUND

• Bundesärztekammer. Beschlussprotokoll des 121. Deutschen Ärztetages in Erfurt vom 08. bis 11.05.2018, Stand 08.06.2018.

  BACKGROUND

• Eatock D. Demografischer Ausblick für die Europäische Union 2019.

  BACKGROUND

• Fehr A, Lange C, Fuchs J, Neuhauser H, Schmitz R. Gesundheitsmonitoring und Gesundheitsindikatoren in Europa. Robert Koch-Institut, Epidemiologie und Gesundheitsberichterstattung; 2017.

  BACKGROUND

• Jacobs K, Kuhlmey A, Greß S, Klauber J, Schwinger A. Pflege-Report 2018. Berlin, Heidelberg: Springer Berlin Heidelberg; 2018.

  BACKGROUND

• Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen. Bedarfsgerechte Steuerung der Gesundheitsversorgung. Gutachten 2018.

  BACKGROUND

• 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.

  PMID: 36167557 DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jörg Christian Brokmann, PD Dr. med.

  Uniklinik RWTH Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Model Details: Stepped-Wedge-Design

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: May 10, 2021
• Study Start: April 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: April 30, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Locations

DE (1)