NCT02585245

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
607

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 6, 2017

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2016

Enrollment Period

8 months

First QC Date

October 21, 2015

Results QC Date

May 25, 2017

Last Update Submit

November 2, 2017

Conditions

Malnutrition

Keywords

Hospital Nutrition screens

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult Hospitalized patients that can consent

You may qualify if:

  • yrs of age
  • Hopitalized

You may not qualify if:

  • Positve for Pregnancy
  • Inability to give Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ThedaCare Regional Medical Center- Appleton

Appleton, Wisconsin, 54911, United States

Location

ThedaCare Regional Medical Center

Neenah, Wisconsin, 54956, United States

Location

Related Publications (6)

  • 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.

    PMID: 24177285BACKGROUND

  • 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.

    PMID: 16356595BACKGROUND

  • 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.

    PMID: 12880610BACKGROUND

  • 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.

    PMID: 24247093BACKGROUND

  • 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.

    PMID: 18682592BACKGROUND

  • 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.

    PMID: 29959847DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Results Point of Contact

Title
Lori Hartz MS, RDN Manager of Nutrition and Diabetes Education
Organization
ThedaCare
lori.hartz@thedacare.org
920 831-5077

Study Officials

  • Lori LK Hartz, MS, RDN

    ThedaCare

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2015

First Posted

October 23, 2015

Study Start

October 1, 2015

Primary Completion

June 1, 2016

Study Completion

October 1, 2016

Last Updated

November 6, 2017

Results First Posted

November 6, 2017

Record last verified: 2016-10

Locations

US(2)