Clinical Nutrition Concept for Hospitalized Patients With Malnutrition

Malnutrition Clinical Trial

— NUTRICORE  

Official title:

Effect of an Evidence Based Clinical Nutrition Concept on Clinical Outcomes in Hospitalized Patients With Malnutrition When Severity of Disease is Taken Into Consideration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673530
• Other study ID #: NUTRICORE
• Status: Completed
• Phase: N/A
• First received: May 1, 2008
• Last updated: March 7, 2016
• Start date: July 2006
• Est. completion date: March 2008

Study information

• Verified date: February 2009
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether there is a positive correlation between an evidence based clinical nutrition concept and relevant clinical outcomes in malnourished hospitalised patients when severity of disease is adjusted.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10242
• Est. completion date: March 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition

Intervention

Behavioral:
• 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.
• care as usual
Unchanged treatment of hospital patients without interference by the study.

Locations

Country	Name	City	State
Germany	Städtisches Klinikum Ansbach	Ansbach
Germany	Kliniken Südliche Weinstraße Landau	Bad Bergzabern
Germany	Evangelische und Johanniter Kliniken	Duisburg
Germany	Kreiskrankenhaus Hameln	Hameln

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay		At least 3 months each group, 6 months for both groups	Yes
Secondary	all cause hospital mortality		At least 3 months each group, 6 months for both groups	Yes
Secondary	complication rate		At least 3 months each group, 6 months for both groups	Yes
Secondary	hospital readmission rate		1 Month each group	Yes
Secondary	Economic devices (direct costs of inpatient care and reimbursement)		At least 4 months each group, 7 months for both groups	No