Energy and protein intake in medical and geriatric inpatients with MEDPass versus conventional administration of oral nutritional supplements: study protocol for the randomized controlled MEDPass Trial

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

MEDPass versus conventional administration of oral nutritional supplements – A randomized controlled trial comparing coverage of energy and protein requirements

“…The MEDPass Trial is a randomized, controlled, open-label clinical superiority trial (RCT) conducted with parallel groups. The design details are published elsewhere [26]. The MEDPass Trial included medical as well as geriatric inpatients at the Tiefenau facility of the University Hospital of Bern.…”

“…Furthermore, patients unable to eat orally or supplemented with or scheduled for enteral or parenteral nutrition were excluded. Lastly, patients with mini mental state examination <16 points, poor German skills or with terminal medical conditions were also excluded [26]. Informed consent for participation in this trial was obtained from all patients by a registered dietitians (RD) [28].…”

“…One of the reasons for liking the MEDPass administration was the fact that medication is easier to swallow with the ONS [15]. However, taking ONS directly with medication was not allowed in the MEDPass Trial to avoid possible foodemedication interactions [26]. Overall, patient preferences trend towards MEDPass administration although individual preferences should be considered whenever possible in clinical practice [50].…”