NCT03928548

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

Malnutrition Clinical Characteristics Validation and Staffing Optimization Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 887 (actual)
• Sponsor: Academy of Nutrition and Dietetics · Academic / Other
• Sex: All
• Age: 1 Month
• Healthy volunteers: Accepted

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

Timeline

• Start date: 2019-06-24
• Primary completion: 2022-08-01
• Completion: 2022-12-31
• First posted: 2019-04-26
• Last updated: 2023-01-31

Locations

2 sites across 1 country: United States