MalnutritionNCT02585245
Comparison of Nutrition Risk Screens
An observational study of Malnutrition, run by ThedaCare at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Malnutrition
- How many people
- 607 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2015to Oct 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Hospitalized patients that can consent
Who may be able to join
- 18 yrs of age
- Hopitalized
Who cannot join
- Positve for Pregnancy
- Inability to give Consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ThedaCare Regional Medical Center- Appleton
Appleton, Wisconsin, 54911
ThedaCare Regional Medical Center
Neenah, Wisconsin, 54956
About this study
Official title: 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.
Read the 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.
- Conditions
- Malnutrition
- Keywords
- Hospital Nutrition screens
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 hr within admission to the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThedaCare
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Lori LK Hartz, MS, RDN, Principal investigator, ThedaCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585245
- Sponsor's protocol ID
- TC0001
- Status last verified
- Oct 2016
- First submitted
- 21 Oct 2015
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24177285Kyle 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.
PubMed 16356595Kondrup 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.
PubMed 12880610Corkins 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.
PubMed 24247093Makhija 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.
PubMed 18682592Hartz 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.
PubMed 29959847
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nutrition Risk Screens in Identification of Hospitalized Patients at Nutrition Risk and/or With Malnutrition.
- ClinicalTrials.gov ID
- NCT02585245
- Acronym / sponsor ID
- TC0001
- Conditions
- Malnutrition
- Keywords
- Hospital Nutrition screens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- ThedaCareUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Hospitalized patients that can consent
Key inclusion criteria (2 listed)
- 18 yrs of age
- Hopitalized
Key exclusion criteria (2 listed)
- Positve for Pregnancy
- Inability to give Consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24177285Malone 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.
- Background: PubMed 16356595Kyle 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.
- Background: PubMed 12880610Kondrup 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.
- Background: PubMed 24247093Corkins 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.
- Background: PubMed 18682592Makhija 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.
- Derived from this study: PubMed 29959847Hartz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori LK Hartz, MS, RDN principal investigator
ThedaCare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by ThedaCare at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02585245, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.