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Clinical Nutrition Concept for Hospitalized Patients With Malnutrition (NUTRICORE)

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
evidence based clinical nutrition concept
care as usual
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Hospital malnutrition, Nutritional Status, Nutrition Assessment, Enteral Nutrition, Parenteral Nutrition, Severity of illness index, cost analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Städtisches Klinikum Ansbach
  • Kliniken Südliche Weinstraße Landau
  • Evangelische und Johanniter Kliniken
  • Kreiskrankenhaus Hameln

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

evidence based clinical nutrition concept

care as usual

Outcomes

Primary Outcome Measures

Length of hospital stay

Secondary Outcome Measures

all cause hospital mortality
complication rate
hospital readmission rate
Economic devices (direct costs of inpatient care and reimbursement)

Full Information

First Posted
May 1, 2008
Last Updated
March 7, 2016
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00673530
Brief Title
Clinical Nutrition Concept for Hospitalized Patients With Malnutrition
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Hospital malnutrition, Nutritional Status, Nutrition Assessment, Enteral Nutrition, Parenteral Nutrition, Severity of illness index, cost analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
evidence based clinical nutrition concept
Arm Title
2
Arm Type
Other
Arm Description
care as usual
Intervention Type
Behavioral
Intervention Name(s)
evidence based clinical nutrition concept
Other Intervention Name(s)
Optimized clinical nutrition concept
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
care as usual
Intervention Description
Unchanged treatment of hospital patients without interference by the study.
Primary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
At least 3 months each group, 6 months for both groups
Secondary Outcome Measure Information:
Title
all cause hospital mortality
Time Frame
At least 3 months each group, 6 months for both groups
Title
complication rate
Time Frame
At least 3 months each group, 6 months for both groups
Title
hospital readmission rate
Time Frame
1 Month each group
Title
Economic devices (direct costs of inpatient care and reimbursement)
Time Frame
At least 4 months each group, 7 months for both groups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan N Willich, Prof. Dr.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Städtisches Klinikum Ansbach
City
Ansbach
Country
Germany
Facility Name
Kliniken Südliche Weinstraße Landau
City
Bad Bergzabern
Country
Germany
Facility Name
Evangelische und Johanniter Kliniken
City
Duisburg
Country
Germany
Facility Name
Kreiskrankenhaus Hameln
City
Hameln
Country
Germany

12. IPD Sharing Statement

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Clinical Nutrition Concept for Hospitalized Patients With Malnutrition

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