Clinical trial NCT03761680: MEDPass Trial: MedPass Versus Conventional Administration of Oral Nutritional Supplements
Official title: MEDPass Trial: MEDPass Versus Conventional Administration of Oral Nutritional Supplements: A RCT Comparing Energy and Protein Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Malnutrition
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Bern University of Applied Sciences
First posted: 2018-12-03
Enrollment: 204
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, open-label, clinical trial
Primary purpose: TREATMENT

Brief summary: The aim of the randomized-controlled, single-center MEDPass trial is to assess the effects of MEDPass versus conventional administration of oral nutritional supplements (ONS) on energy and protein intake in medical and geriatric inpatients.

Detailed description: Disease related malnutrition (DRM) in hospitalized patients is a common problem.The oral nutritional support with ONS is one of the first and most common treatment approach in the patients at nutritional risk. Treatment with ONS may reduce mortality and complications in hospitalized patients.

There are no standards on the type of administration of ONS in terms of timing throughout the day leading to individual approaches. ONS are conventionally served as snacks by nurses, nursing aids or gastronomy personnel between the main meals. The MEDPass-mode offers a different approach by serving ONS together with the medication, three or four times per day, in unusually small portions. Preliminary trials suggest that compliance and cost effectiveness may be improved with the MEDPass-mode.

Enhancing compliance to ONS may not consequently lead to improved total energy and protein intake throughout the day. There has never been a large trial in which total energy- and protein intake of the subjects was studied consequently and systematically throughout the hospitalization. Therefore, this trial will bridge this gap by studying total energy- and protein intake as primary outcomes.

Eligibility criteria: Inclusion Criteria:

* Nutritional risk screening (NRS-2002) total score ≥3 points according to routine screening at admission within 72 hours
* Expected hospital LOS ≥3 days after screening (as estimated by the treating physician)
* Patient qualifies for ONS and approves prescription
* Age \>18 years
* Willingness and ability to provide informed consent

Exclusion Criteria:

* Initially admitted to critical care unit
* Immediate post-operative phase (\<7 days post-surgery)
* Dysphagia with the inability to swallow liquids
* Supplemental enteral and/or parenteral nutrition
* Admitted with, or scheduled for, total parenteral nutrition or tube feeding
* Mini Mental State examination \< 16 points
* hospitalized due to anorexia nervosa
* hospitalized due to acute pancreatitis
* hospitalized due to acute liver failure
* cystic fibrosis
* patients after gastric bypass surgery
* patients with short bowel syndrome
* terminal condition (end of life situation)
* poor skills in German language (study language)

Primary outcomes:
measure: Average intake of energy / day (kcal, % of calculated daily requirement)
timeFrame: throughout the hospitalization: min. 3 to max. 30 days
Secondary outcomes:
measure: Average intake of protein /day (g, % of calculated daily requirement)
timeFrame: throughout the hospitalization: min. 3 to max. 30 days
measure: Average intake of ONS / day (ml)
timeFrame: throughout the hospitalisation: min. 3 to max. 30 days
measure: Development of hand grip strength (kg)
timeFrame: throughout the hospitalisation: min. 3 to max. 30 days
measure: Changes in body weight (kg)
timeFrame: throughout the hospitalisation: min. 3 to max. 30 days
measure: Development of appetite visual analogue scale (VAS)-score (cm)
timeFrame: throughout the hospitalisation: min. 3 to max. 30 days
measure: Development of nausea visual analogue scale (VAS)-score (cm)
timeFrame: throughout the hospitalisation: min. 3 to max. 30 days
measure: Hospital length of stay (LOS)
timeFrame: hospitalization, max. 30 days
measure: Mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Inselspital, Berne, Facility Tiefenau
state: BE
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Zeno Stanga, Prof.Dr.med.
role: STUDY_CHAIR
References:
citation: Kurmann S, Reber E, Vasiloglou MF, Schuetz P, Schoenenberger AW, Uhlmann K, Sterchi AB, Stanga Z. 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. 2021 Mar 16;22(1):210. doi: 10.1186/s13063-021-05145-4.