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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02585245
Other study ID # TC0001
Secondary ID
Status Completed
Phase N/A
First received October 21, 2015
Last updated November 2, 2017
Start date October 2015
Est. completion date October 2016

Study information

Verified date October 2016
Source ThedaCare
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 607
Est. completion date October 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 110 Years
Eligibility Inclusion Criteria:

- 18 yrs of age

- Hopitalized

Exclusion Criteria:

- Positve for Pregnancy

- Inability to give Consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States ThedaCare Regional Medical Center- Appleton Appleton Wisconsin
United States ThedaCare Regional Medical Center Neenah Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
ThedaCare University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Epub 2005 Dec 13. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The Percent of Participants Identified With Malnutrition Using the NRS 2002 and ThedaCare Nutrition Risk Screen Sensitivity: True Positives/ (True Positives +False Negatives) Specificity: True Negatives/ (True Negatives + False Positives) 24 hr within admission to the hospital
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