- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02585245
Comparison of Nutrition Risk Screens
November 2, 2017 updated by: ThedaCare
Comparison of Nutrition Risk Screens in Identification of Hospitalized Patients at Nutrition Risk and/or With Malnutrition.
This research study will compare two different screens for nutrition risk in patients who are in the hospital.
We will be comparing the ThedaCare Nutrition Risk Screen to see if it is as good and consistent as the standard NRS 2002 Nutrition Risk Screen.
Study Overview
Status
Completed
Conditions
Detailed Description
This research study comparing the ThedaCare screen against the NRS 2002 screen will validate the accuracy and reliability of the ThedaCare Screen and the timeliness of nutrition intervention of patients with a diagnosis of malnutrition.
Early nutrition intervention will positively affect the patient's clinical complication, LOS, and readmission.
Study Type
Observational
Enrollment (Actual)
607
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Appleton, Wisconsin, United States, 54911
- ThedaCare Regional Medical Center- Appleton
-
Neenah, Wisconsin, United States, 54956
- ThedaCare Regional Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 110 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult Hospitalized patients that can consent
Description
Inclusion Criteria:
- 18 yrs of age
- Hopitalized
Exclusion Criteria:
- Positve for Pregnancy
- Inability to give Consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
NRS2002 Nutrition Risk Screen
Patients identified at HIgh, medium or Low Risk in Hospitalized patients.
Determining accuracy of identifiying patients affected by malnutrition.
|
|
ThedaCare RD/RN Nutrition Risk Screen
Patients identified at HIgh, medium or Low Risk in Hospitalized patients.
Determining accuracy of identifiying patients affected by malnutrition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Percent of Participants Identified With Malnutrition Using the NRS 2002 and ThedaCare Nutrition Risk Screen
Time Frame: 24 hr within admission to the hospital
|
Sensitivity: True Positives/ (True Positives +False Negatives) Specificity: True Negatives/ (True Negatives + False Positives)
|
24 hr within admission to the hospital
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lori LK Hartz, MS, RDN, ThedaCare
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Corkins MR, Guenter P, DiMaria-Ghalili RA, Jensen GL, Malone A, Miller S, Patel V, Plogsted S, Resnick HE; American Society for Parenteral and Enteral Nutrition. Malnutrition diagnoses in hospitalized patients: United States, 2010. JPEN J Parenter Enteral Nutr. 2014 Feb;38(2):186-95. doi: 10.1177/0148607113512154. Epub 2013 Nov 18.
- Kondrup J, Allison SP, Elia M, Vellas B, Plauth M; Educational and Clinical Practice Committee, European Society of Parenteral and Enteral Nutrition (ESPEN). ESPEN guidelines for nutrition screening 2002. Clin Nutr. 2003 Aug;22(4):415-21. doi: 10.1016/s0261-5614(03)00098-0.
- Malone A, Hamilton C. The Academy of Nutrition and Dietetics/the American Society for Parenteral and Enteral Nutrition consensus malnutrition characteristics: application in practice. Nutr Clin Pract. 2013 Dec;28(6):639-50. doi: 10.1177/0884533613508435. Epub 2013 Oct 31.
- Kyle UG, Kossovsky MP, Karsegard VL, Pichard C. Comparison of tools for nutritional assessment and screening at hospital admission: a population study. Clin Nutr. 2006 Jun;25(3):409-17. doi: 10.1016/j.clnu.2005.11.001. Epub 2005 Dec 13.
- Makhija S, Baker J. The Subjective Global Assessment: a review of its use in clinical practice. Nutr Clin Pract. 2008 Aug-Sep;23(4):405-9. doi: 10.1177/0884533608321214.
- Hartz LLK, Stroup BM, Bibelnieks TA, Shockey C, Ney DM. ThedaCare Nutrition Risk Screen Improves the Identification of Non-Intensive Care Unit Patients at Risk for Malnutrition Compared With the Nutrition Risk Screen 2002. JPEN J Parenter Enteral Nutr. 2019 Jan;43(1):70-80. doi: 10.1002/jpen.1315. Epub 2018 Jun 30.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
October 21, 2015
First Submitted That Met QC Criteria
October 22, 2015
First Posted (Estimate)
October 23, 2015
Study Record Updates
Last Update Posted (Actual)
November 6, 2017
Last Update Submitted That Met QC Criteria
November 2, 2017
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TC0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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