- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02200874
Investigation of the Effectiveness and Efficiency of a Structural Clinical Nutrition Support
Investigation of the Effectiveness and Efficiency of a Structural Clinical Nutrition Support by an Interdisciplinary Nutrition Support Team at the University Hospital Tübingen
Study Overview
Status
Conditions
Detailed Description
In German hospitals disease related malnutrition is a major problem. Malnutrition is known to be associated with decreased quality of life, altered body composition as well as increased length of hospital stay. Guidelines recommend the installation of Nutrition Support Teams (NST) to combat this situation. However, the majority of German hospitals lacks a NST.
In the present study, we want to examine the effectiveness and efficiency of a Nutrition Support Team (NST) in an University hospital with 1500 beds. To do this we investigate the nutritional management, its economic impact and patient related data before and after NST-implementation. Examinations include a structural analysis of the hospital with regard to nutritional procedures and a patient-based analysis.
Patients are recruited from three representative normal wards and two intensive care units. Here we identify patients with risk for malnutrition with the help of nutritional screening tools (NRS 2002 [Nutritional Risk Screening]; NUTRIC [Nutritional Risk in the critically ill] Score).This is performed within the first three days after admittance. The patients with risk for malnutrition (NRS 2002 of 3 or more than 3, NUTRIC Score of 4 or more than 4) are included for further investigations. These include anthropometric measurements , assessment of body composition, evaluation of nosocomial infection and decubitus rate, quality of life (SF-12 questionnaire), length of hospital stay, evaluation of mortality risk, organ function and severity of illness as well as economic factors. Most examinations are repeated weekly depending from the length of stay in hospital.
All this examinations and evaluations will be collected at two time points. Before and after the implementation of a nutritional support team. That means we have two groups: group A- before NST-implementation (n=420) and group B - after NST-implementation (n=420).
After the whole data collection we want to compare the results of the two groups.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Stephan C. Bischoff, Professor
- Phone Number: 0049 711 45924101
- Email: bischoff.stephan@uni-hohenheim.de
Study Contact Backup
- Name: Katrin Mannsdoerfer
- Phone Number: 0049 7071 29 86403
- Email: katrin.mannsdoerfer@med.uni-tuebingen.de
Study Locations
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Tübingen, Germany, 72076
- Recruiting
- University Hospital of Tübingen
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Contact:
- Stephan C. Bischoff, Professor
- Email: bischoff.stephan@uni-hohenheim.de
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Principal Investigator:
- Stephan C. Bischoff, Professor
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Sub-Investigator:
- Katrin Mannsdörfer
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patient of University Hospital Tübingen
- patient of one of the study-wards: Gastroenterology, Otolaryngology, Visceral and transplantation surgery, Internal intensive care unit, Surgery intensive care unit
- written informed consent of the patient/advisor
- risk of malnutrition: NRS Score of 3 or more than 3, NUTRIC Score of 4 or more than 4
Exclusion Criteria:
- age under 18 years
- withdrawn of written informed consent
- length of hospital stay shorter than 2 days
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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before NST-implementation (group A)
Patients with a NRS of 3 or more than 3 or NUTRIC score of 4 or more than 4 within the first three days after admittance to hospital.
Time point: Before implementation of Nutrition Support Team (NST).
|
After NST-implementation (group B)
Patients with a NRS of 3 or more than 3 or NUTRIC score of 4 or more than 4 within the first three days after admittance to hospital.
Time point: After implementation of Nutrition Support Team (NST).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
length of hospital stay
Time Frame: Patients will be followed for the duration of hospital stay. Average hospital stay is about 7 days.
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Patients will be followed for the duration of hospital stay. Average hospital stay is about 7 days.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
case-related total costs of length of hospital stay
Time Frame: At time of hospital discharge.Average hospital stay is about 7 days.
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At time of hospital discharge.Average hospital stay is about 7 days.
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Score (points) of Nutritional risk Screening
Time Frame: Within the first 3 days after admittance
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Patients at normal wards are screened with NRS 2002 (Nutritional Risk Screening 2002).
Patients at intensive care units are screened with NUTRIC (Nutritional Risk in the critically ill) Score.
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Within the first 3 days after admittance
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Score (points) of Nutritional risk Screening
Time Frame: Every 7th day after admittance- until discharge. Average hospital stay is about 7 days.
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Patients on normal wards are screened with NRS 2002 (Nutritional Risk Screening 2002). Patients on intensive care units are screened with NUTRIC (Nutritional Risk in the critically ill) Score. The screening is repeated weekly. |
Every 7th day after admittance- until discharge. Average hospital stay is about 7 days.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
body composition
Time Frame: Within the first 3 days after admittance
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To measure the body composition we use the bioelectrical impedance analysis.
We evaluate the phase angle and ECM (extracellular cell mass)/BCM (body cell mass) ratio.
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Within the first 3 days after admittance
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case-individual costs of hospital stay
Time Frame: At time of hospital discharge.Average hospital stay is about 7 days.
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At time of hospital discharge.Average hospital stay is about 7 days.
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BMI
Time Frame: Within the first 3 days after admittance
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To asses the BMI we measure the height and weight of the patients and calculate the BMI.
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Within the first 3 days after admittance
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body composition
Time Frame: Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.
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To measure the body composition we use the bioelectrical impedance analysis.
We evaluate the phase angle and ECM (extracellular cell mass)/BCM (body cell mass) ratio.
|
Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.
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mortality risk
Time Frame: Within the first 3 days after admittance
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We evaluate the mortality risk by using SAP II (Simplified Acute Physiology) Score.
The SAP II Score is only used on patients at intensive care units.
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Within the first 3 days after admittance
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severity of illness and organ function
Time Frame: Every day -from first day of hospital stay to discharge.Average hospital stay is about 7 days.
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We evaluate the severity of illness and organ function by using SOFA (Sequential Organ Failure Assessment) Score.
The SOFA Score is only used on patients at intensive care units.
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Every day -from first day of hospital stay to discharge.Average hospital stay is about 7 days.
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decubitus risk
Time Frame: within the first 3 days after admittance
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We evaluate decubitus-risk by using Braden-Scale.
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within the first 3 days after admittance
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decubitus risk
Time Frame: Every 7th day after admittance- until discharge. Average hospital stay is about 7 days.
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We evaluate decubitus-risk by using Braden-Scale.
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Every 7th day after admittance- until discharge. Average hospital stay is about 7 days.
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nosocomial infection
Time Frame: At time of hospital discharge.Average hospital stay is about 7 days.
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At time of hospital discharge.Average hospital stay is about 7 days.
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quality of life
Time Frame: within 3 days after admittance
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Quality of life is assessed by using the standardized questionnaire "short-form" 12 ( SF-12).
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within 3 days after admittance
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quality of life
Time Frame: Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.
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Quality of life is assessed by using the standardized questionnaire "short-form 12" (SF-12).
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Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.
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mortality
Time Frame: From day 1 to discharge.Average hospital stay is about 7 days.
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From day 1 to discharge.Average hospital stay is about 7 days.
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BMI
Time Frame: Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.
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To asses the BMI we measure the height and weight of the patients and calculate the BMI. The calculation is repeated weekly. |
Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Stephan C. Bischoff, Professor, Departement of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZEM_NST_KET
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