Malnutrition Clinical Characteristics Validation and Staffing Optimization Study (MCC Study)
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|ClinicalTrials.gov Identifier: NCT03928548|
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : February 2, 2021
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:
- Assess the interrater reliability of the MCC.
- Determine the predictive validity of the adult and pediatric MCC relative to a portfolio of patient medical outcomes.
- Determine the relationship between the adult and pediatric MCC and body composition measurements conducted via bioelectrical impedance analysis (BIA) in a subset of patients.
- Identify the utility of BIA for body composition analysis in clinical settings.
- 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.
- Identify the additional level of RDN care necessary to improve the medical outcomes in patients who have been identified as malnourished using the MCC.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||9600 participants|
|Official Title:||Malnutrition Clinical Characteristics Validation and Staffing Optimization Study|
|Actual Study Start Date :||June 24, 2019|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||December 2022|
Low Risk Malnutrition
Participants who are determined to be at low risk for malnutrition based on the Malnutrition Screening Tool (adults) or the STRONGkids (pediatrics).
High Risk Malnutrition
Participants who are determined to be at high risk for malnutrition based on the Malnutrition Screening Tool (adults) or the STRONGkids (pediatrics).
- Length of stay [ Time Frame: 90 Days ]Number 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 readmissions [ Time Frame: 90 Days ]Number 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) visits [ Time Frame: 90 Days ]Number of times a participant visits the ED after the initial discharge as measured by the existing medical record
- Mortality [ Time Frame: 90 Days ]Participant death as measured by the existing medical record
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928548
|Contact: Elizabeth Y. Jimenez, PhD, RDN, LDfirstname.lastname@example.org|
|Contact: Erin Lamers-Johnson, MS, RDNemail@example.com|
|United States, Florida|
|Daytona Beach, Florida, United States, 32117|
|Contact: Teresa Lutin, MEd, RDN 386-231-3174|
|United States, Kansas|
|The Children's Mercy Hospital||Recruiting|
|Kansas City, Kansas, United States, 64108|
|Contact: Manager, Research Contract Admin 816-701-1345|
|Principal Investigator:||Alison Steiber, PhD, RDN||Academy of Nutrition and Dietetics|