NCT04873973

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,073

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

May 5, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

March 31, 2021

Last Update Submit

May 4, 2021

Conditions

Emergencies

Keywords

telemedicinegeriatricearly warning scoreacute carenursing homeemergency department

Outcome Measures

Primary Outcomes (1)

  • Number of non-realized teleconsultations by request

    Number of non-realized teleconsultations by request

    6 to 15 months depending on the cluster affiliation

Secondary Outcomes (16)

  • 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

    6 to 15 months depending on the cluster affiliation

  • Duration until the realization of a teleconsultation

    6 to 15 months depending on the cluster affiliation

  • Number of causes that lead to system crash

    6 to 15 months depending on the cluster affiliation

  • Data transmission rate requirement

    6 to 15 months depending on the cluster affiliation

  • +11 more secondary outcomes

Other Outcomes (4)

  • Satisfaction survey

    24 months

  • Ethic survey

    24 months

  • Acceptance survey

    24 months

  • +1 more other outcomes

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 supportOTHER

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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital RWTH Aachen

Aachen, 52074, Germany

RECRUITING

Related Publications (10)

  • 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: 17092344BACKGROUND

  • 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: 25662947BACKGROUND

  • 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: 28103927BACKGROUND

  • 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: 26428441BACKGROUND

  • 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: 30226850BACKGROUND

  • 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

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jörg Christian Brokmann, PD Dr. med.

    Uniklinik RWTH Aachen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jörg Christian Brokmann, PD Dr. med.

CONTACT

0241 80 88421jbrokmann@ukaachen.de

Optimal@NRW Project Team

CONTACT

0241 80 38899optimal-nrw@ukaachen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Stepped-Wedge-Design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2021

First Posted

May 5, 2021

Study Start

April 1, 2021

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

May 5, 2021

Record last verified: 2021-05

Locations

DE(1)