MalnutritionNCT02200874
Investigation of the Effectiveness and Efficiency of a Structural Clinical Nutrition Support
An observational study of Malnutrition, run by University of Hohenheim at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- How many people
- 840 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2012to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- age under 18 years
- withdrawn of written informed consent
- length of hospital stay shorter than 2 days
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Tübingen
Tübingen, 72076
Stephan C. Bischoff, Professor, bischoff.stephan@uni-hohenheim.de
Stephan C. Bischoff, Professor
About this study
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
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.
Read the 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.
- Conditions
- Malnutrition
- Keywords
- disease related malnutrition, influence of Nutrition Support Team, length of hospital stay, quality of life, body composition, health care costs
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
length of hospital stay
Measured: 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
Measured: At time of hospital discharge.Average hospital stay is about 7 days.
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.
Measured: Within the first 3 days after admittance
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.
Measured: Every 7th day after admittance- until discharge. Average hospital stay is about 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startNov 2012
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Nutritional Medicine Tuebingen/Hohenheim, University Hospital Tuebingen
- Responsible party
- Principal investigator, Stephan C. Bischoff, MD, Professor, University of Hohenheim
- Investigators
- Stephan C. Bischoff, Professor, Study director, Departement of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200874
- Sponsor's protocol ID
- ZEM_NST_KET
- Status last verified
- Oct 2016
- First submitted
- 23 Jul 2014
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34620359
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02200874
- Acronym / sponsor ID
- ZEM_NST_KET
- Conditions
- Malnutrition
- Keywords
- disease related malnutrition, influence of Nutrition Support Team, length of hospital stay, quality of life, body composition, health care costs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Collaborators
- Center for Nutritional Medicine Tuebingen/Hohenheim, University Hospital Tuebingen
- Study start
- Nov 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- age under 18 years
- withdrawn of written informed consent
- length of hospital stay shorter than 2 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
length of hospital stay
Time frame: Patients will be followed for the duration of hospital stay. Average hospital stay is about 7 days.
3 secondary outcomes
case-related total costs of length of hospital stay
Time frame: 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
Score (points) of Nutritional risk Screening
Time frame: Every 7th day after admittance- until discharge. Average hospital stay is about 7 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 34620359Gonzalez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan C. Bischoff, Professor study director
Departement of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by University of Hohenheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephan C. Bischoff, Professor (0049 711 45924101, bischoff.stephan@uni-hohenheim.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of hospital stay (time frame: Patients will be followed for the duration of hospital stay. Average hospital stay is about 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02200874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.