MEDPass Trial: MedPass Versus Conventional Administration of Oral Nutritional Supplements

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: MEDPass mode of administration
* Dietary Supplement: Control Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled, open-label, clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEDPass Group<br>Allocation of ONS in the MEDPass mode | Dietary Supplement: MEDPass mode of administration<br>* Allocation of 50 ml of ONS four times per day distributed with the medication rounds<br>|
| Active Comparator: Control Group<br>Patients receive ONS between meals or at their request as usual | Dietary Supplement: Control Intervention<br>* Patients receive ONS between meals or at their request as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average intake of energy / day (kcal, % of calculated daily requirement) |  | throughout the hospitalization: min. 3 to max. 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average intake of protein /day (g, % of calculated daily requirement) |  | throughout the hospitalization: min. 3 to max. 30 days | 
| Average intake of ONS / day (ml) |  | 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 | 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. | 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. | 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. | throughout the hospitalisation: min. 3 to max. 30 days | 
| Hospital length of stay (LOS) |  | hospitalization, max. 30 days | 
| Mortality |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnutrition