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Clinical Nutrition Concept for Hospitalized Patients With Malnutrition (NUTRICORE)

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00673530
First received: May 1, 2008
Last updated: February 2, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention
Malnutrition
Behavioral: evidence based clinical nutrition concept
Behavioral: care as usual

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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: At least 3 months each group, 6 months for both groups ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • all cause hospital mortality [ Time Frame: At least 3 months each group, 6 months for both groups ] [ Designated as safety issue: Yes ]
  • complication rate [ Time Frame: At least 3 months each group, 6 months for both groups ] [ Designated as safety issue: Yes ]
  • hospital readmission rate [ Time Frame: 1 Month each group ] [ Designated as safety issue: Yes ]
  • Economic devices (direct costs of inpatient care and reimbursement) [ Time Frame: At least 4 months each group, 7 months for both groups ] [ Designated as safety issue: No ]

Enrollment: 10242
Study Start Date: July 2006
Study Completion Date: March 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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 Name: Optimized clinical nutrition concept
No Intervention: 2 Behavioral: care as usual
Unchanged treatment of hospital patients without interference by the study.
Other Name: care as usual

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673530

Locations
Germany
Städtisches Klinikum Ansbach
Ansbach, Germany
Kliniken Südliche Weinstraße Landau
Bad Bergzabern, Germany
Evangelische und Johanniter Kliniken
Duisburg, Germany
Kreiskrankenhaus Hameln
Hameln, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Director: Stefan N Willich, Prof. Dr. Charite University, Berlin, Germany
  More Information

Additional Information:
No publications provided

Responsible Party: Stefan N. Willich, Charité University Medical Center, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00673530     History of Changes
Other Study ID Numbers: NUTRICORE
Study First Received: May 1, 2008
Last Updated: February 2, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Hospital malnutrition
Nutritional Status
Nutrition Assessment
Enteral Nutrition
Parenteral Nutrition
Severity of illness index
cost analysis

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on November 25, 2014