Clinical trial NCT00242684: PEU in Elderly TCU Residents
Official title: Manifestations, Causes, and Consequences of PEU in Elderly TCU Residents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Keywords: Aging
Undernutrition
Inflammation
Frail Elderly
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-10-20
Enrollment: 446
Sex: ALL
Minimum age (years): 64
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: non-terminally ill adults admitted to the TCU

Brief summary: 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.

Detailed description: 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 approximately 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Subjects With Average Daily Nutrient Intake <70% of Predicted Needs
timeFrame: While hospitalized on TCU, for up to 40 days
Secondary outcomes:
Other outcomes:
Locations:
city: No. Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
state: Arkansas
Study officials:
affiliation: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
name: Dennis H. Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sullivan DH, Johnson LE, Dennis RA, Roberson PK, Garner KK, Padala PR, Padala KP, Bopp MM. Nutrient intake, peripheral edema, and weight change in elderly recuperative care patients. J Gerontol A Biol Sci Med Sci. 2013 Jun;68(6):712-8. doi: 10.1093/gerona/gls234. Epub 2012 Nov 26.
citation: Dennis RA, Johnson LE, Roberson PK, Heif M, Bopp MM, Garner KK, Padala KP, Padala PR, Dubbert PM, Sullivan DH. Changes in activities of daily living, nutrient intake, and systemic inflammation in elderly adults receiving recuperative care. J Am Geriatr Soc. 2012 Dec;60(12):2246-53. doi: 10.1111/jgs.12007. Epub 2012 Nov 23.
citation: Sullivan DH, Roberson PK, Johnson LE, Mendiratta P, Bopp MM, Bishara O. Association between inflammation-associated cytokines, serum albumins, and mortality in the elderly. J Am Med Dir Assoc. 2007 Sep;8(7):458-63. doi: 10.1016/j.jamda.2007.04.004. Epub 2007 Aug 13.
citation: Sullivan DH, Johnson LE, Dennis RA, Roberson PK, Heif M, Garner KK, Bopp MM. The Interrelationships among albumin, nutrient intake, and inflammation in elderly recuperative care patients. J Nutr Health Aging. 2011 Apr;15(4):311-5. doi: 10.1007/s12603-010-0297-1.
citation: Dennis RA, Johnson LE, Roberson PK, Heif M, Bopp MM, Cook J, Sullivan DH. Changes in prealbumin, nutrient intake, and systemic inflammation in elderly recuperative care patients. J Am Geriatr Soc. 2008 Jul;56(7):1270-5. doi: 10.1111/j.1532-5415.2008.01789.x. Epub 2008 Jun 10.