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

Completed

• Conditions: Malnutrition

• Registration Number: NCT03928548
• Lead Sponsor: Academy of Nutrition and Dietetics

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-26
• Study Start: 2019-06-24
• Primary Completion: 2022-08-01
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 887

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Length of stay	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 emergency department (ED) visits	90 Days	Number of times a participant visits the ED after the initial discharge as measured by the existing medical record
Mortality	90 Days	Participant death as measured by the existing medical record
Post-discharge readmissions	90 Days	Number of times a participant is readmitted to the hospital after the initial discharge as measured by the existing medical record

Trial Locations

Locations (2)

The Children's Mercy Hospital; 🇺🇸 Kansas City, Kansas, United States

AdventHealth; 🇺🇸 Daytona Beach, Florida, United States