Malnutrition Clinical Characteristics Validation and Staffing Optimization Study (MCC Study)

Malnutrition Clinical Characteristics Validation and Staffing Optimization Study

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. Assess the interrater reliability of the MCC.
2. Determine the predictive validity of the adult and pediatric MCC relative to a portfolio of patient medical outcomes.
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. Identify the utility of BIA for body composition analysis in clinical settings.
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. Identify the additional level of RDN care necessary to improve the medical outcomes in patients who have been identified as malnourished using the MCC.

Study Overview

• Status: Completed
• Conditions: Malnutrition

• Study Type: Observational
• Enrollment (Actual): 887

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • AdventHealth
  • Kansas
    • Kansas City, Kansas, United States, 64108
      • The Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Academy of Nutrition and Dietetics
• Investigators: Principal Investigator: Alison Steiber, PhD, RDN, Academy of Nutrition and Dietetics

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 24, 2019
• Primary Completion (ACTUAL): August 1, 2022
• Study Completion (ACTUAL): December 31, 2022

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (ACTUAL): April 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 18-594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No