Clinical trial NCT00673530: Clinical Nutrition Concept for Hospitalized Patients With Malnutrition
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
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Hospital malnutrition
Nutritional Status
Nutrition Assessment
Enteral Nutrition
Parenteral Nutrition
Severity of illness index
cost analysis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 10242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Length of hospital stay
timeFrame: At least 3 months each group, 6 months for both groups
Secondary outcomes:
measure: all cause hospital mortality
timeFrame: At least 3 months each group, 6 months for both groups
measure: complication rate
timeFrame: At least 3 months each group, 6 months for both groups
measure: hospital readmission rate
timeFrame: 1 Month each group
measure: Economic devices (direct costs of inpatient care and reimbursement)
timeFrame: At least 4 months each group, 7 months for both groups
Other outcomes:
Locations:
city: Ansbach
country: Germany
facility: Städtisches Klinikum Ansbach
city: Bad Bergzabern
country: Germany
facility: Kliniken Südliche Weinstraße Landau
city: Duisburg
country: Germany
facility: Evangelische und Johanniter Kliniken
city: Hameln
country: Germany
facility: Kreiskrankenhaus Hameln
Study officials:
affiliation: Charite University, Berlin, Germany
name: Stefan N Willich, Prof. Dr.
role: STUDY_DIRECTOR
References: