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Comparison of Nutrition Risk Screens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02585245
Recruitment Status : Completed
First Posted : October 23, 2015
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
ThedaCare

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Malnutrition
Enrollment 607
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description All patients received both the NRS 2002 and the ThedaCare Nutrition Risk Screen. Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
Period Title: Overall Study
Started 607
Completed 594
Not Completed 13
Arm/Group Title All Participants
Hide Arm/Group Description All patients received both the NRS 2002 and the ThedaCare Nutrition Risk Screen. Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
Overall Number of Baseline Participants 594
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 594 participants
63  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 594 participants
Female
318
  53.5%
Male
276
  46.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 594 participants
594
 100.0%
1.Primary Outcome
Title The Percent of Participants Identified With Malnutrition Using the NRS 2002 and ThedaCare Nutrition Risk Screen
Hide Description Sensitivity: True Positives/ (True Positives +False Negatives) Specificity: True Negatives/ (True Negatives + False Positives)
Time Frame 24 hr within admission to the hospital
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NRS2002 Nutrition Risk Screen ThedaCare RD/RN Nutrition Risk Screen
Hide Arm/Group Description:
Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
Overall Number of Participants Analyzed 594 594
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Sensitivity
63.5
(58.3 to 68.7)
98.8
(97.6 to 99.9)
Specificity
94.3
(91.5 to 97.1)
74
(68.7 to 79.2)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not assessed.
 
Arm/Group Title All Participants
Hide Arm/Group Description All patients received both the NRS 2002 and the ThedaCare Nutrition Risk Screen. Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   113/594 (19.02%) 
Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lori Hartz MS, RDN Manager of Nutrition and Diabetes Education
Organization: ThedaCare
Phone: 920 831-5077
EMail: lori.hartz@thedacare.org
Layout table for additonal information
Responsible Party: ThedaCare
ClinicalTrials.gov Identifier: NCT02585245    
Other Study ID Numbers: TC0001
First Submitted: October 21, 2015
First Posted: October 23, 2015
Results First Submitted: May 25, 2017
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017