- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00673530
Clinical Nutrition Concept for Hospitalized Patients With Malnutrition (NUTRICORE)
Effect of an Evidence Based Clinical Nutrition Concept on Clinical Outcomes in Hospitalized Patients With Malnutrition When Severity of Disease is Taken Into Consideration
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Patients have been consecutively screened at admission by SGA (Subjective-Global-Assessment)-Score and NRS 2002 (Nutritional-Risk-Screening)-Score in the departments of surgery and internal medicine. The nutrition status of each patient is combined with clinical data, utilization data and direct costs on the basis of clinical homogenous patient clusters. Risk-Adjustment was provided by the Disease-Staging-Scale (MEDSTAT/Thomson Healthcare, Ann Arbor MI), which allows patient classification by diagnosis and co morbidities including age and gender. The risk adjustment scales run by routine data sets from german inpatient G-DRG system. In the control period the effects of usual nutrition care are documented. During the intervention period an implementation of an interdisciplinary evidence-based guideline for screening and clinical nutrition was introduced in each participating hospital.
The issue is to describe the relation between risk-adjusted malnutrition status and clinical outcomes and costs.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Ansbach, Tyskland
- Städtisches Klinikum Ansbach
-
Bad Bergzabern, Tyskland
- Kliniken Südliche Weinstraße Landau
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Duisburg, Tyskland
- Evangelische und Johanniter Kliniken
-
Hameln, Tyskland
- Kreiskrankenhaus Hameln
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- at least 18 years of age
- internal or operative admission diagnosis in participating hospitals
Exclusion Criteria:
- Patients with demand for emergency care
- Patients with demand for intensive care
- Patients with hospital day-care
- Patients unwilling to participate or unable to comply with the protocol in the control group
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 1
evidence based clinical nutrition concept
|
The evidence based nutrition concept comprise a routine malnutrition screening for hospitalized patients, the implementation of an evidence based guideline for clinical nutrition in the participating hospital, education training of the clinical staff and thereby optimal clinical nutrition for malnourished hospitalized patients.
Andre navn:
|
Annen: 2
care as usual
|
Unchanged treatment of hospital patients without interference by the study.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Length of hospital stay
Tidsramme: At least 3 months each group, 6 months for both groups
|
At least 3 months each group, 6 months for both groups
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
all cause hospital mortality
Tidsramme: At least 3 months each group, 6 months for both groups
|
At least 3 months each group, 6 months for both groups
|
complication rate
Tidsramme: At least 3 months each group, 6 months for both groups
|
At least 3 months each group, 6 months for both groups
|
hospital readmission rate
Tidsramme: 1 Month each group
|
1 Month each group
|
Economic devices (direct costs of inpatient care and reimbursement)
Tidsramme: At least 4 months each group, 7 months for both groups
|
At least 4 months each group, 7 months for both groups
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Stefan N Willich, Prof. Dr., Charite University, Berlin, Germany
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NUTRICORE
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