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

Silvia Kurmann,Maria F. Vasiloglou,Andreas W. Schoenenberger,Philipp Schuetz,Zeno Stanga,Anna-Barbara Sterchi,Katja Uhlmann,Emilie Reber

doi:10.1186/s13063-021-05145-4

Abstract

BackgroundDisease-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.MethodsThe 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.DiscussionTo 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 registrationClinicalTrials.gov NCT03761680. Registered on 3 December 2018. Kofam.ch SNCTP000003191. Registered on 15 October 2018

Highlights

Disease-related malnutrition is highly prevalent in hospitalized medical and geriatric inpatients
The European Society of Clinical Nutrition and Metabolism (ESPEN) recommends the use of Oral nutritional supplements (ONS) for medical and geriatric patients at nutritional risk [10, 14]. These patients often live with chronic illness, which is associated with appetite and body weight loss
The Registered dietitian (RD) calculate daily energy and protein requirements according to relevant current clinical nutrition guidelines that apply to the patients in the MEDPass Trial [10, 14, 33]

Summary

Methods

Study design The MEDPass Trial is a randomized, controlled, clinical trial (RCT) conducted with parallel groups. Study intervention and comparator Every patient in the MEDPass group receives 50 ml of ONS four times per day distributed by the registered nurses (RN) on the ward during medication rounds. Source data is collected mostly from the electronic health record (EHR) This includes the NRS 2002, inand exclusion criteria, patient characteristics, ONS intake, body weight, LOS, and safety outcomes. Forms for collecting data on food intake between the meals and protein and energy intake calculations, are printed out and input manually into REDCap by the RDs. All trial-related paper documents are locked in a specific cabinet in the RD’s office during the whole study period. The RDs calculate daily energy and protein requirements according to relevant current clinical nutrition guidelines that apply to the patients in the MEDPass Trial [10, 14, 33].

Discussion

Background

Evaluation