Silvia Kurmann1, Emilie Reber2, Maria F Vasiloglou3, Philipp Schuetz4, Andreas W Schoenenberger5, Katja Uhlmann6, Anna-Barbara Sterchi2, Zeno Stanga2. 1. Health Division, Department of Nutrition and Dietetics, Research and Development, Bern University of Applied Sciences, Murtenstrasse 10, CH-3010, Bern, Switzerland. silvia.kurmann@bfh.ch. 2. Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, and University of Bern, Freiburgstrasse 15, CH-3010, Bern, Switzerland. 3. AI in Health and Nutrition Laboratory, ARTORG Center for Biomedical Engineering Research, University of Bern, Murtenstrasse 50, CH-3008, Bern, Switzerland. 4. Medical University Department, Clinic for Endocrinology, Diabetes and Metabolism, Division of General Internal and Emergency Medicine, Kantonsspital Aarau and Medical Faculty of the University of Basel, Tellstrasse H7, CH-5001, Aarau, Switzerland. 5. Department of Geriatrics, Inselspital, Bern University Hospital, and University of Bern, Tiefenaustrasse 112, CH-3004, Bern, Switzerland. 6. Health Division, Department of Nutrition and Dietetics, Research and Development, Bern University of Applied Sciences, Murtenstrasse 10, CH-3010, Bern, Switzerland.
Abstract
BACKGROUND: Disease-related malnutrition is highly prevalent in hospitalized medical and geriatric inpatients. It is associated with negative outcomes such as muscle wasting, decline of functional status, and increased morbidity and mortality. Oral nutritional supplements (ONS) are frequently used in nutritional therapy to increase intake. However, compliance to ONS is often limited and maybe improved by prescribing ONS in small portions timed with the medication (MEDPass). However, it is unknown whether the MEDPass administration enhances patients' total energy and protein intake. METHODS: The MEDPass Trial is a randomized, controlled, open-label superiority trial. Patients in the MEDPass group receive 50 ml of ONS four times per day, distributed with the medication rounds. Patients in the control group receive ONS between meals. The primary outcome is average daily energy intake (% of calculated daily requirement). For our power analysis, we assumed that administration of ONS in the MEDPass administration mode increases energy intake by at least 10% (i.e., by 200 kcal for an average energy requirement of 2200 kcal/day). Thus, with the inclusion of 200 patients, this trial has 80% power to demonstrate that intervention group patients have an average intake of 2200 kcal/day (SD 500 kcal) versus 2000 kcal/day (SD 500 kcal) in control group patients. Energy and protein intakes from ONS and all food consumed are monitored continuously throughout the hospital stay and are statistically compared to the patient's requirements. Secondary outcomes include average daily protein intake (% of calculated daily requirement), average intake of ONS/day, the course of body weight, handgrip strength, appetite, and nausea. Furthermore, hospital length of stay and 30-day mortality are assessed. The primary statistical analysis will be performed as an intention-to-treat analysis adjusted for the stratification factors used in randomization. DISCUSSION: To our knowledge, this is the first randomized controlled trial assessing total energy and protein intake for the entire hospitalization period in patients receiving MEDPass versus conventional ONS administration. Thus, the MEDPass Trial will fill a gap and answer this relevant clinical question. TRIAL REGISTRATION: ClinicalTrials.gov NCT03761680 . Registered on 3 December 2018. Kofam.ch SNCTP000003191 . Registered on 15 October 2018.
RCT Entities:
BACKGROUND: Disease-related malnutrition is highly prevalent in hospitalized medical and geriatric inpatients. It is associated with negative outcomes such as muscle wasting, decline of functional status, and increased morbidity and mortality. Oral nutritional supplements (ONS) are frequently used in nutritional therapy to increase intake. However, compliance to ONS is often limited and maybe improved by prescribing ONS in small portions timed with the medication (MEDPass). However, it is unknown whether the MEDPass administration enhances patients' total energy and protein intake. METHODS: The MEDPass Trial is a randomized, controlled, open-label superiority trial. Patients in the MEDPass group receive 50 ml of ONS four times per day, distributed with the medication rounds. Patients in the control group receive ONS between meals. The primary outcome is average daily energy intake (% of calculated daily requirement). For our power analysis, we assumed that administration of ONS in the MEDPass administration mode increases energy intake by at least 10% (i.e., by 200 kcal for an average energy requirement of 2200 kcal/day). Thus, with the inclusion of 200 patients, this trial has 80% power to demonstrate that intervention group patients have an average intake of 2200 kcal/day (SD 500 kcal) versus 2000 kcal/day (SD 500 kcal) in control group patients. Energy and protein intakes from ONS and all food consumed are monitored continuously throughout the hospital stay and are statistically compared to the patient's requirements. Secondary outcomes include average daily protein intake (% of calculated daily requirement), average intake of ONS/day, the course of body weight, handgrip strength, appetite, and nausea. Furthermore, hospital length of stay and 30-day mortality are assessed. The primary statistical analysis will be performed as an intention-to-treat analysis adjusted for the stratification factors used in randomization. DISCUSSION: To our knowledge, this is the first randomized controlled trial assessing total energy and protein intake for the entire hospitalization period in patients receiving MEDPass versus conventional ONS administration. Thus, the MEDPass Trial will fill a gap and answer this relevant clinical question. TRIAL REGISTRATION: ClinicalTrials.gov NCT03761680 . Registered on 3 December 2018. Kofam.ch SNCTP000003191 . Registered on 15 October 2018.
Entities:
Keywords:
Energy intake; MEDPass; Malnutrition; Medication rounds; Nutrition as medication; Oral nutritional supplements; Protein intake
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