Clinical Nutrition Concept for Hospitalized Patients With Malnutrition (NUTRICORE)

March 7, 2016 updated by: Charite University, Berlin, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

10242

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ansbach, Germany
        • Städtisches Klinikum Ansbach
      • Bad Bergzabern, Germany
        • Kliniken Südliche Weinstraße Landau
      • Duisburg, Germany
        • Evangelische und Johanniter Kliniken
      • Hameln, Germany
        • Kreiskrankenhaus Hameln

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
evidence based clinical nutrition concept
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.
Other Names:
  • Optimized clinical nutrition concept
Other: 2
care as usual
Behavioral: care as usual
Unchanged treatment of hospital patients without interference by the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: At least 3 months each group, 6 months for both groups
At least 3 months each group, 6 months for both groups

Secondary Outcome Measures

Outcome Measure
Time Frame
all cause hospital mortality
Time Frame: At least 3 months each group, 6 months for both groups
At least 3 months each group, 6 months for both groups
complication rate
Time Frame: 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
Time Frame: 1 Month each group
1 Month each group
Economic devices (direct costs of inpatient care and reimbursement)
Time Frame: At least 4 months each group, 7 months for both groups
At least 4 months each group, 7 months for both groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Study Director: Stefan N Willich, Prof. Dr., Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

May 1, 2008

First Submitted That Met QC Criteria

May 6, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUTRICORE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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