NCT02200874

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
840

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

4.1 years

First QC Date

July 23, 2014

Last Update Submit

October 25, 2016

Conditions

Malnutrition

Keywords

disease related malnutritioninfluence of Nutrition Support Teamlength of hospital stayquality of lifebody compositionhealth care costs

Outcome Measures

Primary Outcomes (1)

  • length of hospital stay

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

Secondary Outcomes (3)

  • case-related total costs of length of hospital stay

    At time of hospital discharge.Average hospital stay is about 7 days.

  • Score (points) of Nutritional risk Screening

    Within the first 3 days after admittance

  • Score (points) of Nutritional risk Screening

    Every 7th day after admittance- until discharge. Average hospital stay is about 7 days.

Other Outcomes (13)

  • body composition

    Within the first 3 days after admittance

  • case-individual costs of hospital stay

    At time of hospital discharge.Average hospital stay is about 7 days.

  • BMI

    Within the first 3 days after admittance

  • +10 more other outcomes

Study Arms (2)

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).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • age under 18 years
  • withdrawn of written informed consent
  • length of hospital stay shorter than 2 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Tübingen

Tübingen, 72076, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34620359DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Stephan C. Bischoff, Professor

    Departement of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany

    STUDY DIRECTOR

Central Study Contacts

Stephan C. Bischoff, Professor

CONTACT

0049 711 45924101bischoff.stephan@uni-hohenheim.de

Katrin Mannsdoerfer

CONTACT

0049 7071 29 86403katrin.mannsdoerfer@med.uni-tuebingen.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

July 23, 2014

First Posted

July 25, 2014

Study Start

November 1, 2012

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

DE(1)