Investigation of the Effectiveness and Efficiency of a Structural Clinical Nutrition Support

October 25, 2016 updated by: Stephan C. Bischoff, MD, Professor, University of Hohenheim

Investigation of the Effectiveness and Efficiency of a Structural Clinical Nutrition Support by an Interdisciplinary Nutrition Support Team at the University Hospital Tübingen

The purpose of this study is to investigate the effectiveness and efficiency of a structural clinical nutrition support by an interdisciplinary Nutrition Support Team. To do this we examine nutritional management and its economic impact as well as the nutritional status of patients of University Hospital Tübingen before and after the implementation of a Nutritional Support Team.

Study Overview

Status

Unknown

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

Observational

Enrollment (Anticipated)

840

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Tübingen, Germany, 72076
        • Recruiting
        • University Hospital of Tübingen
        • Contact:
        • Principal Investigator:
          • Stephan C. Bischoff, Professor
        • Sub-Investigator:
          • Katrin Mannsdörfer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from University Hospital Tübingen. 420 patiens in each group. Patients from three general wards and two intensive care units. From all patients written informed consent is needed. From sedated and/or ventilated patients, consent from their advisor is needed.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).

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.
Patients will be followed for the duration of hospital stay. Average hospital stay is about 7 days.

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.
At time of hospital discharge.Average hospital stay is about 7 days.
Score (points) of Nutritional risk Screening
Time Frame: Within the first 3 days after admittance
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.
Within the first 3 days after admittance
Score (points) of Nutritional risk Screening
Time Frame: Every 7th day after admittance- until discharge. Average hospital stay is about 7 days.

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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
body composition
Time Frame: Within the first 3 days after admittance
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.
Within the first 3 days after admittance
case-individual costs of hospital stay
Time Frame: At time of hospital discharge.Average hospital stay is about 7 days.
At time of hospital discharge.Average hospital stay is about 7 days.
BMI
Time Frame: Within the first 3 days after admittance
To asses the BMI we measure the height and weight of the patients and calculate the BMI.
Within the first 3 days after admittance
body composition
Time Frame: Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.
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.
mortality risk
Time Frame: Within the first 3 days after admittance
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.
Within the first 3 days after admittance
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.
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.
Every day -from first day of hospital stay to discharge.Average hospital stay is about 7 days.
decubitus risk
Time Frame: within the first 3 days after admittance
We evaluate decubitus-risk by using Braden-Scale.
within the first 3 days after admittance
decubitus risk
Time Frame: Every 7th day after admittance- until discharge. Average hospital stay is about 7 days.
We evaluate decubitus-risk by using Braden-Scale.
Every 7th day after admittance- until discharge. Average hospital stay is about 7 days.
nosocomial infection
Time Frame: At time of hospital discharge.Average hospital stay is about 7 days.
At time of hospital discharge.Average hospital stay is about 7 days.
quality of life
Time Frame: within 3 days after admittance
Quality of life is assessed by using the standardized questionnaire "short-form" 12 ( SF-12).
within 3 days after admittance
quality of life
Time Frame: Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.
Quality of life is assessed by using the standardized questionnaire "short-form 12" (SF-12).
Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.
mortality
Time Frame: From day 1 to discharge.Average hospital stay is about 7 days.
From day 1 to discharge.Average hospital stay is about 7 days.
BMI
Time Frame: Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Stephan C. Bischoff, Professor, Departement of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

July 23, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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