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.

Kurmann, Silvia; Reber, Emilie; Vasiloglou, Maria; Schuetz, Philipp; Schoenenberger, Andreas W.; Uhlmann, Katja; Sterchi, Anna-Barbara; Stanga, Zeno (2021). 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. Trials, 22(1), p. 210. BioMed Central 10.1186/s13063-021-05145-4

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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.

Item Type:

Journal Article (Further Contribution)

Division/Institute:

04 Faculty of Medicine > Department of Gynaecology, Paediatrics and Endocrinology (DFKE) > Clinic of Endocrinology, Diabetology and Clinical Nutrition
10 Strategic Research Centers > ARTORG Center for Biomedical Engineering Research > ARTORG Center - AI in Health and Nutrition
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Geriatric Clinic

UniBE Contributor:

Reber, Emilie; Vasiloglou, Maria; Schoenenberger, Andreas; Sterchi, Anna-Barbara and Stanga, Zeno

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1745-6215

Publisher:

BioMed Central

Language:

English

Submitter:

Rebecca Rufer

Date Deposited:

22 Jul 2021 11:23

Last Modified:

25 Feb 2022 12:48

Publisher DOI:

10.1186/s13063-021-05145-4

PubMed ID:

33726841

Uncontrolled Keywords:

Energy intake MEDPass Malnutrition Medication rounds Nutrition as medication Oral nutritional supplements Protein intake

BORIS DOI:

10.48350/157610

URI:

https://boris.unibe.ch/id/eprint/157610

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