- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Klaus Fassbender, Professor
- Numéro de téléphone: +49 681 302 75027
- E-mail: klaus.fassbender@uks.eu
Sauvegarde des contacts de l'étude
- Nom: Silke Walter
- E-mail: silke.walter@uni-saarland.de
Lieux d'étude
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Saarland
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Homburg, Saarland, Allemagne, 66421
- Nursing Homes in Saarland
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Residents of participating nursing homes
- Informed consent from participant or legal representative
Exclusion Criteria:
- Acute life-threatening conditions requiring immediate hospitalisation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Control Phase (Usual Care)
Usual care including general practitioner (GP) referral, hospital transport, and in-hospital diagnostics and treatment.
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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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Hospital admissions per person-year
Délai: Up to 24 months
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Number of inpatient hospital admissions, excluding elective admissions.
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Up to 24 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mortality
Délai: Day 180
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Mortality
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Day 180
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Functional status; mobility: modified Rankin Scale (mRS)
Délai: 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
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Functional status; frailty: Clinical Frailty Scale
Délai: 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
|
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Cognitive status
Délai: Day 180
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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
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Healthcare costs
Délai: Day 360
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Hospitalisation, transport, and MGU costs
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Day 360
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30-day hospitalisation-free survival
Délai: Day 30
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Hospitalisation-free survival at day 30
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Day 30
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Quality of life (EQ-5D-5L)
Délai: Day 180
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EQ-5D-5L is a standardised measure of health-related quality of life developed by the EuroQol Group and assesses health status in terms of five dimensions of health. The five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems' and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression). Minimum value: 1 (best outcome) Maximum value: 5 (worst outcome) |
Day 180
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Klaus Fassbender, Professor, Universität des Saarlandes
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- MGU
Informations sur les médicaments et les dispositifs, documents d'étude
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