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

Academy of Nutrition and Dietetics

Status: Completed

Conditions: Malnutrition

Study type: Observational

Funder types: Other

Identifiers

NCT03928548

18-594

Details and patient eligibility

About

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.

Enrollment: 887 patients

Sex: All

Ages: 1+ month old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

887 participants in 2 patient groups

Low Risk Malnutrition

Description:

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

Description:

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