Clinical Nutrition Concept for Hospitalized Patients With Malnutrition

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malnutrition

Intervention / Treatment
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* Behavioral: evidence based clinical nutrition concept
* Behavioral: care as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>evidence based clinical nutrition concept | Behavioral: evidence based clinical nutrition concept<br>* 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.<br>* Other names: Optimized clinical nutrition concept;|
| Other: 2<br>care as usual | Behavioral: care as usual<br>* Unchanged treatment of hospital patients without interference by the study.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause hospital mortality |  | At least 3 months each group, 6 months for both groups | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hospital malnutrition, Nutritional Status, Nutrition Assessment, Enteral Nutrition, Parenteral Nutrition, Severity of illness index, cost analysis