NCT02182427

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

July 1, 2014

Last Update Submit

January 26, 2016

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

  • Number of participants diagnosed with and without malnutrition using the MCC.

    30-days post-discharge

Secondary Outcomes (1)

  • 30-day readmission rate among study participants

    Within 90 days after data collection is complete

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

St. John's West Shore Hospital

Westlake, Ohio, 44145, United States

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Related 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.

    PMID: 22709779BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Alison Steiber

    Academy of Nutrition and Dietetics

    PRINCIPAL INVESTIGATOR

  • Maree Ferguson

    Princess Alexandra Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Science Officer

Study Record Dates

First Submitted

July 1, 2014

First Posted

July 8, 2014

Study Start

April 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

AU(1)US(3)