Clinical Nutrition Concept for Hospitalized Patients With Malnutrition

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Behavioral: evidence based clinical nutrition concept; Behavioral: care as usual

• Registration Number: NCT00673530
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2007-12
• Study Completion: 2008-03
• Study First Submitted: 2008-05-01
• Study First Submitted QC: 2008-05-06
• Study First Posted: 2008-05-07
• Status Verified: 2009-02
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10242

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	evidence based clinical nutrition concept	evidence based clinical nutrition concept
2	care as usual	care as usual

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	At least 3 months each group, 6 months for both groups

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Evangelische und Johanniter Kliniken; 🇩🇪 Duisburg, Germany

Kliniken Südliche Weinstraße Landau; 🇩🇪 Bad Bergzabern, Germany

Städtisches Klinikum Ansbach; 🇩🇪 Ansbach, Germany

Kreiskrankenhaus Hameln; 🇩🇪 Hameln, Germany