Abstract
BackgroundMalnutrition is a common consequence of disease in older patients. Both in hospital setting and in community setting oral nutritional support has proven to be effective. However, cost-effectiveness studies are scarce. Therefore, the aim of our study is to investigate the effectiveness and cost-effectiveness of transmural nutritional support in malnourished elderly patients, starting at hospital admission until three months after discharge.MethodsThis study is a randomized controlled trial. Patients are included at hospital admission and followed until three months after discharge. Patients are eligible to be included when they are ≥ 60 years old and malnourished according to the following objective standards: Body Mass Index (BMI in kg/m2) < 20 and/or ≥ 5% unintentional weight loss in the previous month and/or ≥ 10% unintentional weight loss in the previous six months. We will compare usual nutritional care with transmural nutritional support (energy and protein enriched diet, two additional servings of an oral nutritional supplement, vitamin D and calcium supplementation, and consultations by a dietitian). Each study arm will consist of 100 patients. The primary outcome parameters will be changes in activities of daily living (determined as functional limitations and physical activity) between intervention and control group. Secondary outcomes will be changes in body weight, body composition, quality of life, and muscle strength. An economic evaluation from a societal perspective will be conducted alongside the randomised trial to evaluate the cost-effectiveness of the intervention in comparison with usual care.ConclusionIn this randomized controlled trial we will evaluate the effect of transmural nutritional support in malnourished elderly patients after hospital discharge, compared to usual care. Primary endpoints of the study are changes in activities of daily living, body weight, body composition, quality of life, and muscle strength. An economic evaluation will be performed to evaluate the cost-effectiveness of the intervention in comparison with usual care.Trial registrationNetherlands Trial Register (ISRCTN29617677, registered 14-Sep-2005)
Highlights
Malnutrition is a common consequence of disease in older patients
The aim of this study is to investigate the cost-effectiveness of transmural nutritional support in malnourished elderly patients after hospital discharge as compared to usual care on changes in activities of daily living
The study design is in accordance with the Declaration of Helsinki and has been approved by the Medical Ethics Committee (METC) of VU University Medical Center
Summary
Malnutrition is a common consequence of disease in older patients Both in hospital setting and in community setting oral nutritional support has proven to be effective. The aim of our study is to investigate the effectiveness and cost-effectiveness of transmural nutritional support in malnourished elderly patients, starting at hospital admission until three months after discharge. Disease related malnutrition is associated with adverse effects on clinical outcome, as has been shown in a large number of studies. These adverse effects vary from impaired wound healing and postoperative complications to mortality [3]. Poor nutritional status has been associated with in-hospital adverse effects, and with adverse effects both pre-admission and postdischarge. These effects include a trend for increased need for re-hospitalization, significantly higher total mortality, a higher general practitioner consultation rate, higher medication prescription rate, longer rehabilitation, an increased need for nursing home admission, increased likelihood of requiring home health care after discharge and early institutionalization [4,5]
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