Clinical trial NCT02200874: Investigation of the Effectiveness and Efficiency of a Structural Clinical Nutrition Support
Official title: Investigation of the Effectiveness and Efficiency of a Structural Clinical Nutrition Support by an Interdisciplinary Nutrition Support Team at the University Hospital Tübingen
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malnutrition
Keywords: disease related malnutrition
influence of Nutrition Support Team
length of hospital stay
quality of life
body composition
health care costs
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
Collaborators: name: Center for Nutritional Medicine Tuebingen/Hohenheim
name: University Hospital Tuebingen
First posted: 2014-07-25
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: length of hospital stay
timeFrame: Patients will be followed for the duration of hospital stay. Average hospital stay is about 7 days.
Secondary outcomes:
measure: case-related total costs of length of hospital stay
timeFrame: At time of hospital discharge.Average hospital stay is about 7 days.
measure: Score (points) of Nutritional risk Screening
timeFrame: Within the first 3 days after admittance
measure: Score (points) of Nutritional risk Screening
timeFrame: Every 7th day after admittance- until discharge. Average hospital stay is about 7 days.
Other outcomes:
measure: body composition
timeFrame: Within the first 3 days after admittance
measure: case-individual costs of hospital stay
timeFrame: At time of hospital discharge.Average hospital stay is about 7 days.
measure: BMI
timeFrame: Within the first 3 days after admittance
measure: body composition
timeFrame: Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.
measure: mortality risk
timeFrame: Within the first 3 days after admittance
measure: severity of illness and organ function
timeFrame: Every day -from first day of hospital stay to discharge.Average hospital stay is about 7 days.
measure: decubitus risk
timeFrame: within the first 3 days after admittance
measure: decubitus risk
timeFrame: Every 7th day after admittance- until discharge. Average hospital stay is about 7 days.
measure: nosocomial infection
timeFrame: At time of hospital discharge.Average hospital stay is about 7 days.
measure: quality of life
timeFrame: within 3 days after admittance
measure: quality of life
timeFrame: Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.
measure: mortality
timeFrame: From day 1 to discharge.Average hospital stay is about 7 days.
measure: BMI
timeFrame: Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.
Locations:
city: Tübingen
country: Germany
facility: University Hospital of Tübingen
Study officials:
affiliation: Departement of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany
name: Stephan C. Bischoff, Professor
role: STUDY_DIRECTOR
References:
citation: Gonzalez-Granda A, Schollenberger A, Thorsteinsson R, Haap M, Bischoff SC. Impact of an interdisciplinary nutrition support team (NST) on the clinical outcome of critically ill patients. A pre/post NST intervention study. Clin Nutr ESPEN. 2021 Oct;45:486-491. doi: 10.1016/j.clnesp.2021.06.018. Epub 2021 Jun 26.