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Completed

NCT Number: NCT03761680

MEDPass Trial: MedPass Versus Conventional Administration of Oral Nutritional Supplements

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Inselspital, Berne, Facility Tiefenau

Bern, Canton of Bern, 3004, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MEDPass mode of administration

Dietary Supplement

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

Control Intervention

Dietary Supplement

Patients receive ONS between meals or at their request as usual

Primary outcomes

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

    Time frame: throughout the hospitalization: min. 3 to max. 30 days

Secondary outcomes

  1. Average intake of protein /day (g, % of calculated daily requirement)

    Time frame: throughout the hospitalization: min. 3 to max. 30 days

  2. Average intake of ONS / day (ml)

    Time frame: throughout the hospitalisation: min. 3 to max. 30 days

  3. Development of hand grip strength (kg)

    Time frame: throughout the hospitalisation: min. 3 to max. 30 days

    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

  4. Changes in body weight (kg)

    Time frame: throughout the hospitalisation: min. 3 to max. 30 days

    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.

  5. Development of appetite visual analogue scale (VAS)-score (cm)

    Time frame: throughout the hospitalisation: min. 3 to max. 30 days

    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.

  6. Development of nausea visual analogue scale (VAS)-score (cm)

    Time frame: throughout the hospitalisation: min. 3 to max. 30 days

    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.

  7. Hospital length of stay (LOS)

    Time frame: hospitalization, max. 30 days

  8. Mortality

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Bern University of Applied Sciences

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 3, 2018
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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