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MEDPass Trial: MedPass Versus Conventional Administration of Oral Nutritional Supplements

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
MEDPass mode of administration
Control Intervention
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Malnutrition

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital Inselspital, Berne, Facility Tiefenau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MEDPass Group

Control Group

Arm Description

Allocation of ONS in the MEDPass mode

Patients receive ONS between meals or at their request as usual

Outcomes

Primary Outcome Measures

Average intake of energy / day (kcal, % of calculated daily requirement)

Secondary Outcome Measures

Average intake of protein /day (g, % of calculated daily requirement)
Average intake of ONS / day (ml)
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
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.
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.
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.
Hospital length of stay (LOS)
Mortality

Full Information

First Posted
November 23, 2018
Last Updated
March 13, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Bern University of Applied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03761680
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 22, 2018 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Bern University of Applied Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Malnutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled, open-label, clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MEDPass Group
Arm Type
Experimental
Arm Description
Allocation of ONS in the MEDPass mode
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients receive ONS between meals or at their request as usual
Intervention Type
Dietary Supplement
Intervention Name(s)
MEDPass mode of administration
Intervention Description
Allocation of 50 ml of ONS four times per day distributed with the medication rounds
Intervention Type
Dietary Supplement
Intervention Name(s)
Control Intervention
Intervention Description
Patients receive ONS between meals or at their request as usual
Primary Outcome Measure Information:
Title
Average intake of energy / day (kcal, % of calculated daily requirement)
Time Frame
throughout the hospitalization: min. 3 to max. 30 days
Secondary Outcome Measure Information:
Title
Average intake of protein /day (g, % of calculated daily requirement)
Time Frame
throughout the hospitalization: min. 3 to max. 30 days
Title
Average intake of ONS / day (ml)
Time Frame
throughout the hospitalisation: min. 3 to max. 30 days
Title
Development of hand grip strength (kg)
Description
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
Time Frame
throughout the hospitalisation: min. 3 to max. 30 days
Title
Changes in body weight (kg)
Description
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.
Time Frame
throughout the hospitalisation: min. 3 to max. 30 days
Title
Development of appetite visual analogue scale (VAS)-score (cm)
Description
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.
Time Frame
throughout the hospitalisation: min. 3 to max. 30 days
Title
Development of nausea visual analogue scale (VAS)-score (cm)
Description
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.
Time Frame
throughout the hospitalisation: min. 3 to max. 30 days
Title
Hospital length of stay (LOS)
Time Frame
hospitalization, max. 30 days
Title
Mortality
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeno Stanga, Prof.Dr.med.
Organizational Affiliation
Insel Gruppe AG, University Hospital Bern
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Inselspital, Berne, Facility Tiefenau
City
Bern
State/Province
BE
ZIP/Postal Code
3004
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33726841
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.
Results Reference
derived

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MEDPass Trial: MedPass Versus Conventional Administration of Oral Nutritional Supplements

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