Malnutrition Clinical Characteristics Validation Study

Malnutrition Clinical Trial

— MCC  

Official title:

Malnutrition Clinical Characteristics Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02182427
• Other study ID #: 2014-Pilot
• Status: Completed
• Phase: N/A
• First received: July 1, 2014
• Last updated: January 26, 2016
• Start date: April 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Academy of Nutrition and Dietetics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malnutrition

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Brisbane	Queensland
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	St. John's West Shore Hospital	Westlake	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Academy of Nutrition and Dietetics	American Society for Parenteral and Enteral Nutrition

Countries where clinical trial is conducted

United States,  Australia, 

References & Publications (1)

White JV, Guenter P, Jensen G, Malone A, Schofield M; Academy of Nutrition and Dietetics Malnutrition Work Group; A.S.P.E.N. Malnutrition Task Force; A.S.P.E.N. Board of Directors. Consensus statement of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition: characteristics recommended for the identification and documentation of adult malnutrition (undernutrition). J Acad Nutr Diet. 2012 May;112(5):730-8. doi: 10.1016/j.jand.2012.03.012. Epub 2012 Apr 25. Erratum in: J Acad Nutr Diet. 2012 Nov;112(11):1899. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants diagnosed with and without malnutrition using the MCC.		30-days post-discharge	No
Secondary	30-day readmission rate among study participants		Within 90 days after data collection is complete	No