Study protocol: cost-effectiveness of transmural nutritional support in malnourished elderly patients in comparison with usual care.
BACKGROUND
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. 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.


METHODS
This 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 > or = 60 years old and malnourished according to the following objective standards: Body Mass Index (BMI in kg/m2) < 20 and/or > or = 5% unintentional weight loss in the previous month and/or > 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.


CONCLUSIONS
In 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.


BACKGROUND
Netherlands Trial Register (ISRCTN29617677, registered 14-Sep-2005).
Neelemaat
Floor
F
Departments of Nutrition and Dietetics, Internal Medicine and EMGO+ institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands. F.Neelemaat@vumc.nl
Thijs
Abel
A
Seidell
Jaap C
JC
Bosmans
Judith E
JE
van Bokhorst-de van der Schueren
Marian A E
MA
D000203:Activities of Daily Living; D000368:Aged; D001823:Body Composition; D015992:Body Mass Index; D001835:Body Weight; D002118:Calcium / Q000008:administration & dosage; D003362:Cost-Benefit Analysis; D004044:Dietary Proteins / Q000008:administration & dosage; D017097:Electric Impedance; D002149:Energy Intake; D015444:Exercise; D006760:Hospitalization; D006801:Humans; D044342:Malnutrition / Q000628:therapy*; D008875:Middle Aged; D053580:Muscle Strength; D018529:Nutritional Support / Q000191:economics*; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome; D014807:Vitamin D / Q000008:administration & dosage; D015431:Weight Loss
D004044:Dietary Proteins; D014807:Vitamin D; D002118:Calcium