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

Study Overview
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Brief Summary
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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: Assess the interrater reliability of the MCC. Determine the predictive validity of the adult and pediatric MCC relative to a portfolio of patient medical outcomes. Determine the relationship between the adult and pediatric MCC and body composition measurements conducted via bioelectrical impedance analysis (BIA) in a subset of patients. Identify the utility of BIA for body composition analysis in clinical settings. 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. Identify the additional level of RDN care necessary to improve the medical outcomes in patients who have been identified as malnourished using the MCC.

Official Title
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Malnutrition Clinical Characteristics Validation and Staffing Optimization Study

Conditions
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Malnutrition

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low Risk Malnutrition<br>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<br>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?
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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 |