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

NCT ID: NCT04879537

Last Updated: 2023-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emergencies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Stepped-Wedge-Design
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Participants in this group are routinely treated.

Group Type NO_INTERVENTION

No interventions assigned to this group

Telemedical support

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

Group Type ACTIVE_COMPARATOR

Telemedical support

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Optimal@NRW Research Group

UNKNOWN

Sponsor Role collaborator

RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jörg Christian Brokmann

PD Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jörg Christian Brokmann, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Uniklinik RWTH Aachen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital RWTH Aachen

Aachen, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17092344 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25662947 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28103927 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26428441 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30226850 (View on PubMed)

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

Reference Type BACKGROUND

Eatock D. Demografischer Ausblick für die Europäische Union 2019.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type DERIVED
PMID: 36167557 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19-019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Telemedicine and Nursing Home
NCT02816177 COMPLETED NA
Short-term Caregiver Psychotherapy
NCT02175953 COMPLETED PHASE2
Growing Old at Home
NCT00644826 COMPLETED NA