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

Malnutrition Clinical Characteristics Validation and Staffing Optimization Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03928548
Enrollment
887
Registered
2019-04-26
Start date
2019-06-24
Completion date
2022-12-31
Last updated
2023-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

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.

Interventions

None listed

Sponsors

Academy of Nutrition and Dietetics
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Length of stay90 DaysNumber 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 readmissions90 DaysNumber 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) visits90 DaysNumber of times a participant visits the ED after the initial discharge as measured by the existing medical record
Mortality90 DaysParticipant death as measured by the existing medical record

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026