MEDPass Trial: MedPass Versus Conventional Administration of Oral Nutritional Supplements

NCT ID: NCT03761680

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-22
• Study Completion Date: 2021-12-31

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.

Conditions

Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MEDPass Group

Allocation of ONS in the MEDPass mode

Group Type: EXPERIMENTAL

MEDPass mode of administration

Intervention Type: DIETARY_SUPPLEMENT

Allocation of 50 ml of ONS four times per day distributed with the medication rounds

Control Group

Patients receive ONS between meals or at their request as usual

Group Type: ACTIVE_COMPARATOR

Control Intervention

Intervention Type: DIETARY_SUPPLEMENT

Patients receive ONS between meals or at their request as usual

Interventions

MEDPass mode of administration

Allocation of 50 ml of ONS four times per day distributed with the medication rounds

Intervention Type: DIETARY_SUPPLEMENT

Control Intervention

Patients receive ONS between meals or at their request as usual

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bern University of Applied Sciences

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zeno Stanga, Prof.Dr.med.

Role: STUDY_CHAIR

Insel Gruppe AG, University Hospital Bern

Locations

University Hospital Inselspital, Berne, Facility Tiefenau

Bern, Canton of Bern, Switzerland

Countries

Switzerland

References

Kurmann S, Reber E, Schonenberger KA, Schuetz P, Uhlmann K, Vasiloglou MF, Schoenenberger AW, Bertschi D, Sterchi AB, Stanga Z. MEDPass versus conventional administration of oral nutritional supplements - A randomized controlled trial comparing coverage of energy and protein requirements. Clin Nutr. 2023 Feb;42(2):108-115. doi: 10.1016/j.clnu.2022.11.015. Epub 2022 Dec 5.

Reference Type: DERIVED

PMID: 36525797 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33726841 (View on PubMed)

Other Identifiers

3804

Identifier Type: -

Identifier Source: org_study_id