- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07634757
Mobile Geriatric Unit (MGU) to Reduce Hospitalisations in Nursing Home Residents (MGU)
Mobile Geriatric Unit (MGU) to Reduce Hospitalisations in Nursing Home Residents: A Prospective Observational Before-After Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This prospective observational before-after study evaluates the impact of a Mobile Geriatric Unit (MGU) on hospitalisation rates among nursing home residents in Saarland, Germany. The study includes a 12-month control phase with usual care followed by a 12-month intervention phase with MGU implementation in 46 nursing homes.
The MGU provides on-site advanced diagnostics (CT, X-ray, ultrasound, ECG, EEG, and laboratory testing) supported by telemedicine consultation with hospital specialists. A physician and radiology technician perform diagnostics in the nursing home, with results communicated to the general practitioner for treatment decisions within 48 hours.
Usual care involves hospital referral and in-hospital diagnostics. The intervention aims to reduce avoidable hospital admissions by providing diagnostics and specialist input directly in the nursing home.
The primary outcome is hospital admissions per person-year. Secondary outcomes include mortality, functional and cognitive status, quality of life (EQ-5D-5L), complications, healthcare costs, and 30-day hospitalisation-free survival.
Eligible participants are nursing home residents with consent or proxy consent; those requiring immediate hospitalisation are excluded.
Data are obtained from routine care and medical records, MGU documentation, structured assessments, and follow-up. Multilevel Poisson regression and interrupted time series analysis will be used.
The study was approved by the Ethics Committee of Saarland (AZ 159-21) and conducted in accordance with the Declaration of Helsinki.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Klaus Fassbender, Professor
- Telefonnummer: +49 681 302 75027
- E-mail: klaus.fassbender@uks.eu
Undersøgelse Kontakt Backup
- Navn: Silke Walter
- E-mail: silke.walter@uni-saarland.de
Studiesteder
-
-
Saarland
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Homburg, Saarland, Tyskland, 66421
- Nursing Homes in Saarland
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Residents of participating nursing homes
- Informed consent from participant or legal representative
Exclusion Criteria:
- Acute life-threatening conditions requiring immediate hospitalisation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Control Phase (Usual Care)
Usual care including general practitioner (GP) referral, hospital transport, and in-hospital diagnostics and treatment.
|
|
|
Intervention Phase (MGU)
On-site diagnostic evaluation using the Mobile Geriatric Unit with broad diagnostic capabilities followed by teleconsultation and further treatment by the general practitioner.
|
The MGU is a mobile diagnostic unit providing on-site diagnostics in nursing homes.
It includes a 32-slice (64 slice reconstruction) whole body CT scanner, digital X-ray, portable ultrasound, ECG, EEG, and point-of-care laboratory diagnostics.
A physician and radiology technician perform diagnostics on-site.
Results are transmitted via telemedicine to hospital specialists and communicated to the general practitioner for treatment decisions within 48 hours.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hospital admissions per person-year
Tidsramme: Up to 24 months
|
Number of inpatient hospital admissions, excluding elective admissions.
|
Up to 24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mortality
Tidsramme: Day 180
|
Mortality
|
Day 180
|
|
Functional status; mobility: modified Rankin Scale (mRS)
Tidsramme: Day 180
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Modified Rankin Scale (mRS): 0: No symptoms
Minimum value: 0 (best outcome) Maximum value: 6 (worst outcome) |
Day 180
|
|
Functional status; frailty: Clinical Frailty Scale
Tidsramme: Day 180
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Clinical Frailty Scale (as according to Moorhouse and Rockwood*):
Minimum value: 1 (best outcome) Maximum value: 9 (worst outcome) * Moorhouse P, Rockwood K. Frailty and its quantitative clinical evaluation. J R Coll Physicians Edinb 2012; 42: 333-40 |
Day 180
|
|
Cognitive status
Tidsramme: Day 180
|
The cognitive performance assessment is carried out through subjective evaluation by the nursing home's nursing staff at day 180.
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Day 180
|
|
Quality of life (EQ-5D-5L)
Tidsramme: Day 180
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EQ-5D-5L
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Day 180
|
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Healthcare costs
Tidsramme: Day 360
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Hospitalisation, transport, and MGU costs
|
Day 360
|
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30-day hospitalisation-free survival
Tidsramme: Day 30
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Hospitalisation-free survival at day 30
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Day 30
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Klaus Fassbender, Professor, Universität Des Saarlandes
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- MGU
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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