NCT03928548

Brief Summary

The purpose of this study is to establish the validity of the adult and pediatric Malnutrition Clinical Characteristics (MCC). In addition, this project will: examine the relationship between the MCC and an objective measure of body composition; and establish the relationship between in-patient Registered Dietitian Nutritionist (RDN) care and medical outcomes for all in-patients requiring nutrition care, and specifically for malnourished patients. Sixty pediatric and 60 adult in-patient acute care facilities will participate in this research study. The total number of participants enrolled across the 120 facilities will be between 2400-9600. The aims of the study include:

  1. 1.Assess the interrater reliability of the MCC.
  2. 2.Determine the predictive validity of the adult and pediatric MCC relative to a portfolio of patient medical outcomes.
  3. 3.Determine the relationship between the adult and pediatric MCC and body composition measurements conducted via bioelectrical impedance analysis (BIA) in a subset of patients.
  4. 4.Identify the utility of BIA for body composition analysis in clinical settings.
  5. 5.Estimate the level of RDN care necessary to improve patient outcomes within the portfolio of outcomes. Specifically: quantify the dose (minutes of care and frequency of encounters) of RDN care that is associated with improved medical outcomes in patients already identified as requiring nutrition care, after adjusting for disease severity and other potential confounders.
  6. 6.Identify the additional level of RDN care necessary to improve the medical outcomes in patients who have been identified as malnourished using the MCC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
887

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration 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

First Submitted

Initial submission to the registry

April 10, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 24, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

3.1 years

First QC Date

April 10, 2019

Last Update Submit

January 30, 2023

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (4)

  • Length of stay

    Number of days a participant is in-patient at an acute care hospital (discharge date - admission date) as measured by the existing medical record

    90 Days

  • Post-discharge readmissions

    Number of times a participant is readmitted to the hospital after the initial discharge as measured by the existing medical record

    90 Days

  • Post discharge emergency department (ED) visits

    Number of times a participant visits the ED after the initial discharge as measured by the existing medical record

    90 Days

  • Mortality

    Participant death as measured by the existing medical record

    90 Days

Study Arms (2)

Low Risk Malnutrition

Participants who are determined to be at low risk for malnutrition based on the Malnutrition Screening Tool (adults) or the STRONGkids (pediatrics).

High Risk Malnutrition

Participants who are determined to be at high risk for malnutrition based on the Malnutrition Screening Tool (adults) or the STRONGkids (pediatrics).

Eligibility Criteria

Age1 Month+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All eligible patients (according to the inclusion and exclusion criteria seen below) who are admitted to the participating hospitals in the United States.

You may qualify if:

  • Adult and pediatric acute care patients at participating facility
  • Newly identified as needing in-patient nutrition care through current facility policy
  • Receive initial nutrition care one day before study enrollment day
  • Patient is over one month of age, including infants, children, teenagers and adult patients who are intubated and/or sedated
  • Patient, parent, legal guardian or legally authorized representative provide informed consent; children 7 and older provide assent
  • Patient and/or parent, legal guardian or legally authorized representative are fluent in English or Spanish

You may not qualify if:

  • Received nutrition care previously during current admission
  • Pregnant women
  • Prisoners
  • Infants currently in the neonatal intensive care unit (NICU) with a diagnosis of prematurity
  • Neonates of uncertain viability or non-viable neonates
  • Patients receiving palliative/hospice care
  • Patient admitted for long-term acute care (LTAC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AdventHealth

Daytona Beach, Florida, 32117, United States

Location

The Children's Mercy Hospital

Kansas City, Kansas, 64108, United States

Location

Related Publications (4)

  • Jimenez EY, Lamers-Johnson E, Long JM, McCabe G, Ma X, Woodcock L, Bliss C, Abram JK, Steiber AL. Predictive validity of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition indicators to diagnose malnutrition tool in hospitalized adults: a cohort study. Am J Clin Nutr. 2024 Mar;119(3):779-787. doi: 10.1016/j.ajcnut.2023.12.012. Epub 2024 Feb 12.

    PMID: 38432715DERIVED

  • Jimenez EY, Lamers-Johnson E, Long JM, Mordarski BA, Ma X, Steiber A. Completion of a Nutrition-Focused Physical Exam with hospitalized adults and pediatric patients: Secondary analysis of a prospective cohort study. Nutr Clin Pract. 2024 Aug;39(4):888-902. doi: 10.1002/ncp.11137. Epub 2024 Feb 19.

    PMID: 38372592DERIVED

  • Lamers-Johnson E, Will VK, Long JM, Woodcock L, Kelley K, Steiber AL, Jimenez EY. Factors Associated with IRB Review Time in a Non-Federally Funded Study Using an sIRB of Record. Ethics Hum Res. 2023 Jul-Aug;45(4):16-29. doi: 10.1002/eahr.500173.

    PMID: 37368522DERIVED

  • Jimenez EY, Long JM, Lamers-Johnson E, Woodcock L, Bliss C, Lee J, Scott Parrott J, Hand RK, Kelley K, Abram JK, Steiber A. Academy of Nutrition and Dietetics Nutrition Research Network: Rationale and Protocol for a Study to Validate the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition Consensus-Derived Diagnostic Indicators For Adult And Pediatric Malnutrition and to Determine Optimal Registered Dietitian Nutritionist Staffing in Acute Care Hospital Settings. J Acad Nutr Diet. 2022 Mar;122(3):630-639. doi: 10.1016/j.jand.2021.03.017. Epub 2021 May 4.

    PMID: 33962901DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Alison Steiber, PhD, RDN

    Academy of Nutrition and Dietetics

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 10, 2019

First Posted

April 26, 2019

Study Start

June 24, 2019

Primary Completion

August 1, 2022

Study Completion

December 31, 2022

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)