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

Malnutrition Clinical Trial

Official title:

Malnutrition Clinical Characteristics Validation and Staffing Optimization Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03928548
• Other study ID #: 18-594
• Status: Completed
• Start date: June 24, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Academy of Nutrition and Dietetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 887
• Est. completion date: December 31, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month and older

Eligibility

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)

Related Conditions & MeSH terms

• Malnutrition

Locations

Country	Name	City	State
United States	AdventHealth	Daytona Beach	Florida
United States	The Children's Mercy Hospital	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Academy of Nutrition and Dietetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Mortality	Participant death as measured by the existing medical record	90 Days