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. CONCLUSION: 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. TRIAL REGISTRATION: Netherlands Trial Register (ISRCTN29617677, registered 14-Sep-2005)

Prevention of malnutrition in older people during and after hospitalisation: results from a randomised controlled clinical trial

Objective: to prevent the occurrence of weight loss during hospitalisation and following discharge by daily oral supplementation. Design: in a prospective, randomised, controlled study of 80 patients aged 75 or more, and at risk of undernutrition based on their initial Mini Nutritional Assessment score, patients were randomised into a control group or one receiving oral supplementation. The intervention was a prescription of 200 ml sweet or salty sip feed twice daily (500 kcal, 21 g protein per day) throughout hospitalisation and convalescence. Nutritional status was assessed at baseline and after 2 months using Mini Nutritional Assessment and body weight record. Results: compliance with oral supplementation was good and daily extra energy intake was 407+/-184 kcal. On day 60, significant weight loss from upon admission was observed in the control group (-1.23+/-2.5 kg; P=0.01), but not in the supplemented group (0.28+/-3.8 kg; NS). At the end of the study, Mini Nutritional Assessment scores were higher in the supplemented group than in the control group (23.5+/-3.9 versus 20.8+/-3.6; P<0.01). Conclusion: use of daily oral supplementation during and after hospitalisation maintains body weight and increases Mini Nutritional Assessment score in patients at risk of undernutrition