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PEU in Elderly TCU Residents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00242684
First received: October 18, 2005
Last updated: September 24, 2014
Last verified: September 2014

October 18, 2005
September 24, 2014
March 2006
April 2012   (final data collection date for primary outcome measure)
adverse clinical event [ Time Frame: post TCU admission ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00242684 on ClinicalTrials.gov Archive Site
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PEU in Elderly TCU Residents
Manifestations, Causes, and Consequences of PEU in Elderly TCU Residents

Background: There is tremendous controversy regarding the adequacy/effectiveness of the nutritional care provided in VA Transitional Care Units (TCUs). The interrelationship between concurrent inflammatory disease, the adequacy of a resident's nutrient consumption, the development or resolution of putative nutritional deficits, and clinical outcomes is not established. Given the known obstacles to increasing nutrient intake (e.g. cost, resident acceptance, associated morbidity) and the lack of proven effectiveness of all forms of nutrition support and nutritional supplementation to improve clinical outcomes, a better understanding of these interrelationships is needed and will be the focus of this study.

Objectives: The primary objective of this study is to determine how best to define nutritional risk (i.e., risk for adverse clinical outcomes due to inadequate nutrient intake) among older VA TCU residents. As part of this objective, we will seek to develop a better understanding of the interrelationship between nutrient intake, weight change, serum concentration of albumins, health status/illness severity, and mortality. The secondary objective is to develop a prediction model for identifying which TCU residents are likely to have ongoing problems with low nutrient intake. The ultimate objective is to develop a clinically useful system to identify residents who are likely to benefit from specific interventions aimed at improving nutritional risk.

Background: There is tremendous controversy regarding the adequacy/effectiveness of the nutritional care provided in VA Transitional Care Units (TCUs). The interrelationship between concurrent inflammatory disease, the adequacy of a resident's nutrient consumption, the development or resolution of putative nutritional deficits, and clinical outcomes is not established. Given the known obstacles to increasing nutrient intake (e.g. cost, resident acceptance, associated morbidity) and the lack of proven effectiveness of all forms of nutrition support and nutritional supplementation to improve clinical outcomes, a better understanding of these interrelationships is needed and will be the focus of this study.

Objectives: The primary objective of this study is to determine how best to define nutritional risk (i.e., risk for adverse clinical outcomes due to inadequate nutrient intake) among older VA TCU residents. As part of this objective, we will seek to develop a better understanding of the interrelationship between nutrient intake, weight change, serum concentration of albumins, health status/illness severity, and mortality. The secondary objective is to develop a prediction model for identifying which TCU residents are likely to have ongoing problems with low nutrient intake. The ultimate objective is to develop a clinically useful system to identify residents who are likely to benefit from specific interventions aimed at improving nutritional risk.

Methods: To meet these objectives, 400 older, non-terminally ill veterans admitted to a VA TCU (where average length of stay is approx 90 days) will be prospectively studied using the same methodologic approach validated in prior VA hospital-based investigations. After completing a comprehensive admission assessment, each subject will be monitored closely throughout his/her TCU stay with serial nutrient intake and recurring metabolic, functional, neuropsychological, cognitive, nutritional, and medical assessments. Weights, anthropometrics, and blood for serum proteins, inflammatory markers (e.g., cytokines), and other select lab indices will be obtained at least monthly until discharged. Resting metabolic rate (by indirect calorimetry) will be obtained on select residents. Each subject will remain in the study for 12 months. From discharge through the end of the subject's study year, each subject will be monitored by phone to determine survival and days of institutional (e.g., hospital, NH) care. At study's end, strengths of associations will be assessed using univariable and multivariable analytic techniques including logistic and Cox Proportional-Hazards analyses.

Findings: See citations linked.

Status: Status: Funding began 9-1-2005. Subject recruitment began 3-1-2006. To date, we have recruited 446 subjects into the study. 446 subjects have been discharged from the inpatient phase of the study. The average length of stay for these subjects is 32 days.

Impact: Our study will provide a clearer understanding of what factors contribute to the apparent nutritional deficits seen in many older veterans residing in VA nursing home TCUs. The study will also lead to the development of a clinically useful system to identify TCU residents who are likely to benefit from specific interventions aimed at improving nutritional risk and thus clinical outcomes.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum and plasma samples

Probability Sample

non-terminally ill adults admitted to the TCU

Aging
Not Provided
Group 1
older patients admitted to a TCU unit

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
446
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

> 64 years of age, admitted to the TCU

Exclusion Criteria:

If they: have a terminal disease (eg end-stage organ failure refractory to medical management receiving palliate care).

Both
64 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00242684
IIR 04-298
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Dennis H. Sullivan, MD Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
Department of Veterans Affairs
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP