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.

Condition
Aging

Further study details as provided by Department of Veterans Affairs:

Expected Total Enrollment:  400

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 protiens, 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:

No results at this time.

Status:

Funding began 9-1-2005. Subject recruitment is scheduled to begin 1-1-2006.

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.

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

greater than 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).

Please refer to this study by ClinicalTrials.gov identifier  NCT00242684

Lena Inoue      (415) 221-4810  Ext. 2590    lena.inoue@va.gov
Claudine Catledge, MA      (415) 221-4810  Ext. 4954    claudine.catledge@va.gov

Arkansas
      Little Rock, AR, Little Rock,  Arkansas,  72205,  United States

Study chairs or principal investigators

Dennis Sullivan, MD,  Principal Investigator,  Little Rock, AR   

Study ID Numbers:  IIR 04-298
Last Updated:  December 8, 2005
Record first received:  October 18, 2005
ClinicalTrials.gov Identifier:  NCT00242684
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10