- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Ansbach, Tyskland
- Städtisches Klinikum Ansbach
-
Bad Bergzabern, Tyskland
- Kliniken Südliche Weinstraße Landau
-
Duisburg, Tyskland
- Evangelische und Johanniter Kliniken
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Hameln, Tyskland
- Kreiskrankenhaus Hameln
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
Andra namn:
|
Övrig: 2
care as usual
|
Unchanged treatment of hospital patients without interference by the study.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Length of hospital stay
Tidsram: At least 3 months each group, 6 months for both groups
|
At least 3 months each group, 6 months for both groups
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
all cause hospital mortality
Tidsram: At least 3 months each group, 6 months for both groups
|
At least 3 months each group, 6 months for both groups
|
complication rate
Tidsram: 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
Tidsram: 1 Month each group
|
1 Month each group
|
Economic devices (direct costs of inpatient care and reimbursement)
Tidsram: At least 4 months each group, 7 months for both groups
|
At least 4 months each group, 7 months for both groups
|
Samarbetspartners och utredare
Utredare
- Studierektor: Stefan N Willich, Prof. Dr., Charite University, Berlin, Germany
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NUTRICORE
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