MEDPass Trial: MedPass Versus Conventional Administration of Oral Nutritional Supplements

MEDPass Trial: MEDPass Versus Conventional Administration of Oral Nutritional Supplements: A RCT Comparing Energy and Protein Intake

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Dietary supplement: MEDPass mode of administration; Dietary supplement: Control Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • BE
    • Bern, BE, Switzerland, 3004
      • University Hospital Inselspital, Berne, Facility Tiefenau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MEDPass Group; Allocation of ONS in the MEDPass mode	Dietary supplement: MEDPass mode of administration; Allocation of 50 ml of ONS four times per day distributed with the medication rounds
Active Comparator: Control Group; Patients receive ONS between meals or at their request as usual	Dietary supplement: Control Intervention; Patients receive ONS between meals or at their request as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average intake of energy / day (kcal, % of calculated daily requirement)	throughout the hospitalization: min. 3 to max. 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		30 days
Average intake of protein /day (g, % of calculated daily requirement)		throughout the hospitalization: min. 3 to max. 30 days
Average intake of ONS / day (ml)		throughout the hospitalisation: min. 3 to max. 30 days
Development of hand grip strength (kg)	Monitored at day 1, day 8, day 15, 22 and 29 or at discharge if at least 5 days after the last measurement have past. Evaluated with the JAMAR® Hydraulic Hand Dynamometer (Patterson Medical, Warrenville, IL, USA). If possible, measurements are conducted on the dominant hand, three times with a break of at least 30 seconds between the measurements. The highest value is noted. Accuracy: 0.5 kg. Range: 0.0 - 90.0 kg	throughout the hospitalisation: min. 3 to max. 30 days
Changes in body weight (kg)	Monitored at day 1, day 8, day 15, 22 and 29 or at discharge if at least 5 days after the last measurement have past. Accuracy: 0.1 kg.	throughout the hospitalisation: min. 3 to max. 30 days
Development of appetite visual analogue scale (VAS)-score (cm)	Monitored at day 1, day 8, day 15, 22 and 29 or at discharge if at least 5 days after the last measurement have past. The present day is the focus of the assessment. On the front of the scale which is visible to the patient, only smileys are shown. The scale on the back ranges from 0-10 cm to objectify the measurement with 10 cm being the most desirable. Accuracy:0.1 cm.	throughout the hospitalisation: min. 3 to max. 30 days
Development of nausea visual analogue scale (VAS)-score (cm)	Monitored at day 1, day 8, day 15, 22 and 29 or at discharge if at least 5 days after the last measurement have past. The present day is the focus of the assessment. On the front of the scale which is visible to the patient, only smileys are shown. The scale on the back ranges from 0-10 cm to objectify the measurement with 10 cm being the most desirable. Accuracy: 0.1 cm.	throughout the hospitalisation: min. 3 to max. 30 days
Hospital length of stay (LOS)		hospitalization, max. 30 days

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: Bern University of Applied Sciences
• Investigators: Study Chair: Zeno Stanga, Prof.Dr.med., University Hospital Inselspital, Berne

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2018
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: November 23, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Malnutrition
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 3804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No