Clinical trial NCT03928548: Malnutrition Clinical Characteristics Validation and Staffing Optimization Study (MCC Study)
Official title: Malnutrition Clinical Characteristics Validation and Staffing Optimization Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Lead sponsor: Academy of Nutrition and Dietetics
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 887
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All eligible patients (according to the inclusion and exclusion criteria seen below) who are admitted to the participating hospitals in the United States.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Length of stay
timeFrame: 90 Days
measure: Post-discharge readmissions
timeFrame: 90 Days
measure: Post discharge emergency department (ED) visits
timeFrame: 90 Days
measure: Mortality
timeFrame: 90 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: AdventHealth
state: Florida
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Kansas
Study officials:
affiliation: Academy of Nutrition and Dietetics
name: Alison Steiber, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jimenez EY, Long JM, Lamers-Johnson E, Woodcock L, Bliss C, Lee J, Scott Parrott J, Hand RK, Kelley K, Abram JK, Steiber A. Academy of Nutrition and Dietetics Nutrition Research Network: Rationale and Protocol for a Study to Validate the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition Consensus-Derived Diagnostic Indicators For Adult And Pediatric Malnutrition and to Determine Optimal Registered Dietitian Nutritionist Staffing in Acute Care Hospital Settings. J Acad Nutr Diet. 2022 Mar;122(3):630-639. doi: 10.1016/j.jand.2021.03.017. Epub 2021 May 4.