MalnutritionNCT03761680
MEDPass Trial: MedPass Versus Conventional Administration of Oral Nutritional Supplements
A study testing MEDPass mode of administration in people with Malnutrition, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- MEDPass mode of administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Nov 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Inselspital, Berne, Facility Tiefenau
Bern, Canton of Bern, 3004
About this study
Official title: 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.
Read the 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
- Being tested
- MEDPass mode of administration, Control Intervention
- Keywords
- Malnutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDPass mode of administrationDietary supplement
Allocation of 50 ml of ONS four times per day distributed with the medication rounds
Control InterventionDietary supplement
Patients receive ONS between meals or at their request as usual
| Study group | Role | What they receive |
|---|---|---|
| MEDPass Group | Experimental | Allocation of ONS in the MEDPass mode Receives: Dietary Supplement: MEDPass mode of administration |
| Control Group | Active comparator | Patients receive ONS between meals or at their request as usual Receives: Dietary Supplement: Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average intake of energy / day (kcal, % of calculated daily requirement)
Measured: throughout the hospitalization: min. 3 to max. 30 days
Secondary outcomes (8)
Average intake of protein /day (g, % of calculated daily requirement)
Measured: throughout the hospitalization: min. 3 to max. 30 days
Average intake of ONS / day (ml)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: throughout the hospitalisation: min. 3 to max. 30 days
Hospital length of stay (LOS)
Measured: hospitalization, max. 30 days
Mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start22 Nov 2018
- Primary completion30 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, open-label, clinical trial
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Zeno Stanga, Prof.Dr.med., Study chair, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761680
- Sponsor's protocol ID
- 3804
- Status last verified
- Mar 2023
- First submitted
- 23 Nov 2018
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36525797Kurmann 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.
PubMed 33726841
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEDPass Trial: MEDPass Versus Conventional Administration of Oral Nutritional Supplements: A RCT Comparing Energy and Protein Intake
- ClinicalTrials.gov ID
- NCT03761680
- Acronym / sponsor ID
- 3804
- Conditions
- Malnutrition
- Keywords
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, open-label, clinical trial
| Arm | Type | Receives |
|---|---|---|
| MEDPass Group | Experimental | Dietary Supplement: MEDPass mode of administrationAllocation of ONS in the MEDPass mode |
| Control Group | Active comparator | Dietary Supplement: Control InterventionPatients receive ONS between meals or at their request as usual |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDPass mode of administrationAllocation of 50 ml of ONS four times per day distributed with the medication rounds | Dietary supplement | MEDPass Group |
| Control InterventionPatients receive ONS between meals or at their request as usual | Dietary supplement | Control Group |
Primary outcome
Average intake of energy / day (kcal, % of calculated daily requirement)
Time frame: throughout the hospitalization: min. 3 to max. 30 days
8 secondary outcomes
Average intake of protein /day (g, % of calculated daily requirement)
Time frame: throughout the hospitalization: min. 3 to max. 30 days
Average intake of ONS / day (ml)
Time frame: throughout the hospitalisation: min. 3 to max. 30 days
Development of hand grip strength (kg)
Time frame: throughout the hospitalisation: min. 3 to max. 30 days
Changes in body weight (kg)
Time frame: throughout the hospitalisation: min. 3 to max. 30 days
Development of appetite visual analogue scale (VAS)-score (cm)
Time frame: throughout the hospitalisation: min. 3 to max. 30 days
Development of nausea visual analogue scale (VAS)-score (cm)
Time frame: throughout the hospitalisation: min. 3 to max. 30 days
Hospital length of stay (LOS)
Time frame: hospitalization, max. 30 days
Mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Derived from this study: PubMed 36525797Kurmann 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.
- Derived from this study: PubMed 33726841Kurmann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeno Stanga, Prof.Dr.med. study chair
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEDPass mode of administration in people with Malnutrition, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average intake of energy / day (kcal, % of calculated daily requirement) (time frame: throughout the hospitalization: min. 3 to max. 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03761680, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.