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

NCT03928548 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 887

Last updated 2023-01-31

No results posted yet for this study

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.

Conditions

  • Malnutrition

Sponsors & Collaborators

  • Academy of Nutrition and Dietetics

    lead OTHER

Principal Investigators

  • Alison Steiber, PhD, RDN · Academy of Nutrition and Dietetics

Eligibility

Min Age
1 Month
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2022-08-01
Completion
2022-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03928548 on ClinicalTrials.gov