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Malnutrition Clinical Characteristics Validation Study (MCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182427
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : January 27, 2016
Sponsor:
Collaborator:
American Society for Parenteral and Enteral Nutrition
Information provided by (Responsible Party):
Alison Steiber, Academy of Nutrition and Dietetics

Brief Summary:
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.

Condition or disease
Malnutrition

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Study Type : Observational [Patient Registry]
Actual Enrollment : 54 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Malnutrition Clinical Characteristics Validation Study
Study Start Date : April 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition




Primary Outcome Measures :
  1. Number of participants diagnosed with and without malnutrition using the MCC. [ Time Frame: 30-days post-discharge ]

Secondary Outcome Measures :
  1. 30-day readmission rate among study participants [ Time Frame: Within 90 days after data collection is complete ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

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): NCT02182427


Locations
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United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
St. John's West Shore Hospital
Westlake, Ohio, United States, 44145
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Sponsors and Collaborators
Academy of Nutrition and Dietetics
American Society for Parenteral and Enteral Nutrition
Investigators
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Principal Investigator: Alison Steiber Academy of Nutrition and Dietetics
Study Chair: Maree Ferguson Princess Alexandra Hospital

Additional Information:

Publications:
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Responsible Party: Alison Steiber, Chief Science Officer, Academy of Nutrition and Dietetics
ClinicalTrials.gov Identifier: NCT02182427    
Other Study ID Numbers: 2014-Pilot
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders