<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02200874</url>
  </required_header>
  <id_info>
    <org_study_id>ZEM_NST_KET</org_study_id>
    <nct_id>NCT02200874</nct_id>
  </id_info>
  <brief_title>Investigation of the Effectiveness and Efficiency of a Structural Clinical Nutrition Support</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Hohenheim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Center for Nutritional Medicine Tuebingen/Hohenheim</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Hohenheim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effectiveness and efficiency of a structural&#xD;
      clinical nutrition support by an interdisciplinary Nutrition Support Team. To do this we&#xD;
      examine nutritional management and its economic impact as well as the nutritional status of&#xD;
      patients of University Hospital Tübingen before and after the implementation of a Nutritional&#xD;
      Support Team.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In German hospitals disease related malnutrition is a major problem. Malnutrition is known to&#xD;
      be associated with decreased quality of life, altered body composition as well as increased&#xD;
      length of hospital stay. Guidelines recommend the installation of Nutrition Support Teams&#xD;
      (NST) to combat this situation. However, the majority of German hospitals lacks a NST.&#xD;
&#xD;
      In the present study, we want to examine the effectiveness and efficiency of a Nutrition&#xD;
      Support Team (NST) in an University hospital with 1500 beds. To do this we investigate the&#xD;
      nutritional management, its economic impact and patient related data before and after&#xD;
      NST-implementation. Examinations include a structural analysis of the hospital with regard to&#xD;
      nutritional procedures and a patient-based analysis.&#xD;
&#xD;
      Patients are recruited from three representative normal wards and two intensive care units.&#xD;
      Here we identify patients with risk for malnutrition with the help of nutritional screening&#xD;
      tools (NRS 2002 [Nutritional Risk Screening]; NUTRIC [Nutritional Risk in the critically ill]&#xD;
      Score).This is performed within the first three days after admittance. The patients with risk&#xD;
      for malnutrition (NRS 2002 of 3 or more than 3, NUTRIC Score of 4 or more than 4) are&#xD;
      included for further investigations. These include anthropometric measurements , assessment&#xD;
      of body composition, evaluation of nosocomial infection and decubitus rate, quality of life&#xD;
      (SF-12 questionnaire), length of hospital stay, evaluation of mortality risk, organ function&#xD;
      and severity of illness as well as economic factors. Most examinations are repeated weekly&#xD;
      depending from the length of stay in hospital.&#xD;
&#xD;
      All this examinations and evaluations will be collected at two time points. Before and after&#xD;
      the implementation of a nutritional support team. That means we have two groups: group A-&#xD;
      before NST-implementation (n=420) and group B - after NST-implementation (n=420).&#xD;
&#xD;
      After the whole data collection we want to compare the results of the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>Patients will be followed for the duration of hospital stay. Average hospital stay is about 7 days.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>case-related total costs of length of hospital stay</measure>
    <time_frame>At time of hospital discharge.Average hospital stay is about 7 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score (points) of Nutritional risk Screening</measure>
    <time_frame>Within the first 3 days after admittance</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score (points) of Nutritional risk Screening</measure>
    <time_frame>Every 7th day after admittance- until discharge. Average hospital stay is about 7 days.</time_frame>
    <description>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.&#xD;
The screening is repeated weekly.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>body composition</measure>
    <time_frame>Within the first 3 days after admittance</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>case-individual costs of hospital stay</measure>
    <time_frame>At time of hospital discharge.Average hospital stay is about 7 days.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>BMI</measure>
    <time_frame>Within the first 3 days after admittance</time_frame>
    <description>To asses the BMI we measure the height and weight of the patients and calculate the BMI.</description>
  </other_outcome>
  <other_outcome>
    <measure>body composition</measure>
    <time_frame>Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>mortality risk</measure>
    <time_frame>Within the first 3 days after admittance</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>severity of illness and organ function</measure>
    <time_frame>Every day -from first day of hospital stay to discharge.Average hospital stay is about 7 days.</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>decubitus risk</measure>
    <time_frame>within the first 3 days after admittance</time_frame>
    <description>We evaluate decubitus-risk by using Braden-Scale.</description>
  </other_outcome>
  <other_outcome>
    <measure>decubitus risk</measure>
    <time_frame>Every 7th day after admittance- until discharge. Average hospital stay is about 7 days.</time_frame>
    <description>We evaluate decubitus-risk by using Braden-Scale.</description>
  </other_outcome>
  <other_outcome>
    <measure>nosocomial infection</measure>
    <time_frame>At time of hospital discharge.Average hospital stay is about 7 days.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>quality of life</measure>
    <time_frame>within 3 days after admittance</time_frame>
    <description>Quality of life is assessed by using the standardized questionnaire &quot;short-form&quot; 12 ( SF-12).</description>
  </other_outcome>
  <other_outcome>
    <measure>quality of life</measure>
    <time_frame>Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.</time_frame>
    <description>Quality of life is assessed by using the standardized questionnaire &quot;short-form 12&quot; (SF-12).</description>
  </other_outcome>
  <other_outcome>
    <measure>mortality</measure>
    <time_frame>From day 1 to discharge.Average hospital stay is about 7 days.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>BMI</measure>
    <time_frame>Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.</time_frame>
    <description>To asses the BMI we measure the height and weight of the patients and calculate the BMI.&#xD;
The calculation is repeated weekly.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">840</enrollment>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>before NST-implementation (group A)</arm_group_label>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>After NST-implementation (group B)</arm_group_label>
    <description>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).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from University Hospital Tübingen. 420 patiens in each group. Patients from three&#xD;
        general wards and two intensive care units. From all patients written informed consent is&#xD;
        needed. From sedated and/or ventilated patients, consent from their advisor is needed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient of University Hospital Tübingen&#xD;
&#xD;
          -  patient of one of the study-wards: Gastroenterology, Otolaryngology, Visceral and&#xD;
             transplantation surgery, Internal intensive care unit, Surgery intensive care unit&#xD;
&#xD;
          -  written informed consent of the patient/advisor&#xD;
&#xD;
          -  risk of malnutrition: NRS Score of 3 or more than 3, NUTRIC Score of 4 or more than 4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age under 18 years&#xD;
&#xD;
          -  withdrawn of written informed consent&#xD;
&#xD;
          -  length of hospital stay shorter than 2 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephan C. Bischoff, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Departement of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stephan C. Bischoff, Professor</last_name>
    <phone>0049 711 45924101</phone>
    <email>bischoff.stephan@uni-hohenheim.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Katrin Mannsdoerfer</last_name>
    <phone>0049 7071 29 86403</phone>
    <email>katrin.mannsdoerfer@med.uni-tuebingen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital of Tübingen</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephan C. Bischoff, Professor</last_name>
      <email>bischoff.stephan@uni-hohenheim.de</email>
    </contact>
    <investigator>
      <last_name>Stephan C. Bischoff, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katrin Mannsdörfer</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>October 25, 2016</last_update_submitted>
  <last_update_submitted_qc>October 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Hohenheim</investigator_affiliation>
    <investigator_full_name>Stephan C. Bischoff, MD, Professor</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>disease related malnutrition</keyword>
  <keyword>influence of Nutrition Support Team</keyword>
  <keyword>length of hospital stay</keyword>
  <keyword>quality of life</keyword>
  <keyword>body composition</keyword>
  <keyword>health care costs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02200874
org study id: ZEM_NST_KET
nct id: NCT02200874
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
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.
observational model: Case-Control
time perspective: Prospective
measure: length of hospital stay
time frame: Patients will be followed for the duration of hospital stay. Average hospital stay is about 7 days.
measure: case-related total costs of length of hospital stay
time frame: At time of hospital discharge.Average hospital stay is about 7 days.
measure: Score (points) of Nutritional risk Screening
time frame: Within the first 3 days after admittance
description: 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.
measure: Score (points) of Nutritional risk Screening
time frame: Every 7th day after admittance- until discharge. Average hospital stay is about 7 days.
description: 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.
measure: body composition
time frame: Within the first 3 days after admittance
description: 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.
measure: case-individual costs of hospital stay
time frame: At time of hospital discharge.Average hospital stay is about 7 days.
measure: BMI
time frame: Within the first 3 days after admittance
description: To asses the BMI we measure the height and weight of the patients and calculate the BMI.
measure: body composition
time frame: Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.
description: 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.
measure: mortality risk
time frame: Within the first 3 days after admittance
description: 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.
measure: 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.
description: 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.
measure: decubitus risk
time frame: within the first 3 days after admittance
description: We evaluate decubitus-risk by using Braden-Scale.
measure: decubitus risk
time frame: Every 7th day after admittance- until discharge. Average hospital stay is about 7 days.
description: We evaluate decubitus-risk by using Braden-Scale.
measure: nosocomial infection
time frame: At time of hospital discharge.Average hospital stay is about 7 days.
measure: quality of life
time frame: within 3 days after admittance
description: Quality of life is assessed by using the standardized questionnaire "short-form" 12 ( SF-12).
measure: quality of life
time frame: Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.
description: Quality of life is assessed by using the standardized questionnaire "short-form 12" (SF-12).
measure: mortality
time frame: From day 1 to discharge.Average hospital stay is about 7 days.
measure: BMI
time frame: Every 7th day after admittance -until discharge. Average hospital stay is about 7 days.
description: To asses the BMI we measure the height and weight of the patients and calculate the BMI.
The calculation is repeated weekly.
arm group label: before NST-implementation (group A)
description: 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).
arm group label: After NST-implementation (group B)
description: 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).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephan C. Bischoff, Professor
role: Study Director
affiliation: Departement of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany
last name: Stephan C. Bischoff, Professor
phone: 0049 711 45924101
email: bischoff.stephan@uni-hohenheim.de
last name: Katrin Mannsdoerfer
phone: 0049 7071 29 86403
email: katrin.mannsdoerfer@med.uni-tuebingen.de
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Hohenheim
investigator full name: Stephan C. Bischoff, MD, Professor
investigator title: Prof. Dr.
mesh term: Malnutrition