MEDPass Trial: MedPass Versus Conventional Administration of Oral Nutritional Supplements

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: Control Intervention; Dietary Supplement: MEDPass mode of administration

Study type: Interventional

Funder types: Other

Identifiers

NCT03761680

3804

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

MEDPass Group

Experimental group

Description:

Allocation of ONS in the MEDPass mode

Treatment:

Dietary Supplement: MEDPass mode of administration

Control Group

Active Comparator group

Description:

Patients receive ONS between meals or at their request as usual

Treatment:

Dietary Supplement: Control Intervention