Clinical Nutrition Concept for Hospitalized Patients With Malnutrition

NCT ID: NCT00673530

Last Updated: 2016-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2008-03-31

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.

Conditions

Malnutrition

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

evidence based clinical nutrition concept

Group Type: EXPERIMENTAL

evidence based clinical nutrition concept

Intervention Type: BEHAVIORAL

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.

2

care as usual

Group Type: OTHER

care as usual

Intervention Type: BEHAVIORAL

Unchanged treatment of hospital patients without interference by the study.

Interventions

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.

Intervention Type: BEHAVIORAL

care as usual

Unchanged treatment of hospital patients without interference by the study.

Intervention Type: BEHAVIORAL

Other Intervention Names

Optimized clinical nutrition concept

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Charité University Medical Center, Berlin, Germany

Principal Investigators

Stefan N Willich, Prof. Dr.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

Städtisches Klinikum Ansbach

Ansbach, , Germany

Kliniken Südliche Weinstraße Landau

Bad Bergzaben, , Germany

Evangelische und Johanniter Kliniken

Duisburg, , Germany

Kreiskrankenhaus Hameln

Hamelin, , Germany

Countries

Germany

Other Identifiers

NUTRICORE

Identifier Type: -

Identifier Source: org_study_id