Malnutrition Clinical Characteristics Validation Study (MCC)

January 26, 2016 updated by: Alison Steiber, Academy of Nutrition and Dietetics
Malnutrition (under-nutrition) occurs in approximately 30% of hospitalized adults worldwide and results in poor outcomes. However there is no universal method for diagnosing malnutrition. A group of experts created a set of 6 characteristics to identify malnutrition. The goal of this project is to determine whether these characteristics are the best indicators to identify malnutrition or if there are other factors that may better identify malnutrition. Because there is no gold standard definition for malnutrition, the investigators will compare the characteristics against outcomes such as length of stay, hospital readmission and death. Outcomes are also influenced by disease state, therefore, information on what brought the patient to the hospital and what happened to them in the hospital will be collected that allows the investigators to separate the effect of malnutrition from disease. The hypothesis for this study is that the malnutrition clinical characteristics and diagnosis criteria, as presented by the experts, are valid and reliable principles for the diagnosis of adult under-nutrition.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Princess Alexandra Hospital
  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
      • Westlake, Ohio, United States, 44145
        • St. John's West Shore Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All eligible patients (according to the inclusion and exclusion criteria seen below) who are admitted to one of the following acute care facilities: University Hospitals Case Medical Center, Cleveland Clinic, and St. John's Westshore in Cleveland, Ohio, United States, and Princess Alexandra Hospital in Brisbane, Queensland, Australia.

Description

Inclusion Criteria:

  • Patient on inpatient dietitian consult list
  • Able to speak English to answer questions
  • Ability to provide informed consent (or provided by family member)
  • Expected remaining admission time > 24 hours (determined by no mention of pending discharge in physicians notes)
  • Age ≥ 18 years

Exclusion Criteria:

  • Seen previously by Registered Dietitian during current admission
  • Patient on hospice or palliative care, in a psychiatric, maternity, pediatric or day surgery area, or in dedicated trauma or burn unit.
  • Life expectancy <7 days per physician note or Registered Dietitian (RD) judgment
  • Participated in the study during a previous admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants diagnosed with and without malnutrition using the MCC.
Time Frame: 30-days post-discharge
30-days post-discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
30-day readmission rate among study participants
Time Frame: Within 90 days after data collection is complete
Within 90 days after data collection is complete

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academy of Nutrition and Dietetics

Collaborators

American Society for Parenteral and Enteral Nutrition

Investigators

  • Principal Investigator: Alison Steiber, Academy of Nutrition and Dietetics
  • Study Chair: Maree Ferguson, Princess Alexandra Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

July 1, 2014

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-Pilot

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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