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

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ClinicalTrials.gov Identifier: NCT03928548
Recruitment Status : Not yet recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Academy of Nutrition and Dietetics

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.

Condition or disease
Malnutrition

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Study Type : Observational
Estimated Enrollment : 9600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Malnutrition Clinical Characteristics Validation and Staffing Optimization Study
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Group/Cohort
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).



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Mortality [ Time Frame: 90 Days ]
    Participant death as measured by the existing medical record



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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)

Information from the National Library of Medicine

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


Contacts
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Contact: Elizabeth Y. Jimenez, PhD, RDN, LD 312-899-4720 bjimenez@eatright.org
Contact: Erin Lamers-Johnson, MS, RDN elamersjohnson@eatright.org

Sponsors and Collaborators
Academy of Nutrition and Dietetics
Investigators
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Principal Investigator: Alison Steiber, PhD, RDN Academy of Nutrition and Dietetics

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Responsible Party: Academy of Nutrition and Dietetics
ClinicalTrials.gov Identifier: NCT03928548     History of Changes
Other Study ID Numbers: 18-594
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders