Malnutrition Clinical Characteristics Validation and Staffing Optimization Study (MCC 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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

1 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AdventHealth, Daytona Beach, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

Length of stay

Time frame: 90 Days

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

Time frame: 90 Days

Number of times a participant is readmitted to the hospital after the initial discharge as measured by the existing medical record
Post discharge emergency department (ED) visits

Time frame: 90 Days

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

Time frame: 90 Days

Participant death as measured by the existing medical record

Sponsors and collaborators

Lead sponsor

Academy of Nutrition and Dietetics

Other

Registry information

Official study title

Malnutrition Clinical Characteristics Validation and Staffing Optimization Study

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Apr 26, 2019
Registry last updated: Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed