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

Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02200874
• Other study ID #: ZEM_NST_KET
• Status: Recruiting
• Phase: N/A
• First received: July 23, 2014
• Last updated: October 25, 2016
• Start date: November 2012
• Est. completion date: June 2017

Study information

• Verified date: October 2016
• Source: University of Hohenheim
• Contact: Stephan C. Bischoff, Professor
• Phone: 0049 711 45924101
• Email: bischoff.stephan[@]uni-hohenheim.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 840
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malnutrition

Locations

Country	Name	City	State
Germany	University Hospital of Tübingen	Tübingen

Sponsors (3)

Lead Sponsor	Collaborator
University of Hohenheim	Center for Nutritional Medicine Tuebingen/Hohenheim, University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	body composition	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	No
Other	case-individual costs of hospital stay		At time of hospital discharge.Average hospital stay is about 7 days.	No
Other	BMI	To asses the BMI we measure the height and weight of the patients and calculate the BMI.	Within the first 3 days after admittance	No
Other	body composition	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.	No
Other	mortality risk	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	No
Other	severity of illness and organ function	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.	No
Other	decubitus risk	We evaluate decubitus-risk by using Braden-Scale.	within the first 3 days after admittance	No
Other	decubitus risk	We evaluate decubitus-risk by using Braden-Scale.	Every 7th day after admittance- until discharge. Average hospital stay is about 7 days.	No
Other	nosocomial infection		At time of hospital discharge.Average hospital stay is about 7 days.	No
Other	quality of life	Quality of life is assessed by using the standardized questionnaire "short-form" 12 ( SF-12).	within 3 days after admittance	No
Other	quality of life	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.	No
Other	mortality		From day 1 to discharge.Average hospital stay is about 7 days.	No
Other	BMI	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.	No
Primary	length of hospital stay		Patients will be followed for the duration of hospital stay. Average hospital stay is about 7 days.	No
Secondary	case-related total costs of length of hospital stay		At time of hospital discharge.Average hospital stay is about 7 days.	No
Secondary	Score (points) of Nutritional risk Screening	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	No
Secondary	Score (points) of Nutritional risk Screening	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.	No