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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
Allocation of 50 ml of ONS four times per day distributed with the medication rounds
Patients receive ONS between meals or at their request as usual
University Hospital Inselspital, Berne, Facility Tiefenau
Bern, Canton of Bern, Switzerland
Average intake of energy / day (kcal, % of calculated daily requirement)
Time frame: throughout the hospitalization: min. 3 to max. 30 days
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)
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
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.
Time frame: 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.
Time frame: throughout the hospitalisation: min. 3 to max. 30 days
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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.
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