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

Abstract Background Disease-related malnutrition is highly prevalent in hospitalized medical and geriatric inpatients. It is associated with negative outcomes such as muscle wasting, decline of functional status, and increased morbidity and mortality. Oral nutritional supplements (ONS) are frequently used in nutritional therapy to increase intake. However, compliance to ONS is often limited and maybe improved by prescribing ONS in small portions timed with the medication (MEDPass). However, it is unknown whether the MEDPass administration enhances patients’ total energy and protein intake. Methods The MEDPass Trial is a randomized, controlled, open-label superiority trial. Patients in the MEDPass group receive 50 ml of ONS four times per day, distributed with the medication rounds. Patients in the control group receive ONS between meals. The primary outcome is average daily energy intake (% of calculated daily requirement). For our power analysis, we assumed that administration of ONS in the MEDPass administration mode increases energy intake by at least 10% (i.e., by 200 kcal for an average energy requirement of 2200 kcal/day). Thus, with the inclusion of 200 patients, this trial has 80% power to demonstrate that intervention group patients have an average intake of 2200 kcal/day (SD 500 kcal) versus 2000 kcal/day (SD 500 kcal) in control group patients. Energy and protein intakes from ONS and all food consumed are monitored continuously throughout the hospital stay and are statistically compared to the patient’s requirements. Secondary outcomes include average daily protein intake (% of calculated daily requirement), average intake of ONS/day, the course of body weight, handgrip strength, appetite, and nausea. Furthermore, hospital length of stay and 30-day mortality are assessed. The primary statistical analysis will be performed as an intention-to-treat analysis adjusted for the stratification factors used in randomization. Discussion To our knowledge, this is the first randomized controlled trial assessing total energy and protein intake for the entire hospitalization period in patients receiving MEDPass versus conventional ONS administration. Thus, the MEDPass Trial will fill a gap and answer this relevant clinical question

MEDPass versus conventional administration of oral nutritional supplements - A randomized controlled trial comparing coverage of energy and protein requirements.

BACKGROUND & AIMS The use of oral nutritional supplements (ONS) in the hospital setting is important to reach individual protein and energy goals in patients at risk for malnutrition. Compliance with ONS can be challenging but may be improved by prescribing ONS in smaller portions with medication rounds (MEDPass). We compared the likelihood of meeting energy and protein requirements in patients receiving ONS with MEDPass versus conventional ONS administration. METHODS The MEDPass Trial is a randomized, controlled, open-label superiority trial conducted on medical and geriatric wards in a University Hospital in Switzerland. The MEDPass group was allocated to receive 50 ml of ONS four times per day with the medication rounds. The control group received ONS per conventional care between the meals. The primary outcome was the percentage of energy in relation to the individual requirement. Secondary outcomes included the coverage of protein intake in relation to the individual requirement, the amount of daily consumed ONS, the course of handgrip strength (HGS), body weight appetite and nausea. Furthermore, we compared 30-day mortality and hospital length of stay (LOS) was studied in medical patients. RESULTS From November 22nd, 2018 until November 30th, 2021, 204 patients were included in the trial (MEDPass group n = 100, control group n = 104). A total of 203 patients at nutritional risk were analyzed in the intention-to-treat analysis (ITT). Regarding the primary endpoint, there was no difference in the coverage of energy requirement between the MEDPass and control group (82 vs. 85% (Δ -3%, 95%CI -11 to 4%), p = 0.38). Similarly, no differences were found for the secondary outcomes including coverage of protein requirement (101 vs. 104% (Δ -3%, 95% CI -12 -7%), p = 0.57, average daily intake of ONS (170 vs 173 ml (Δ - 3 ml, 95% CI -14 to 8 ml), p = 0.58) and 30-day mortality (3 vs. 8 patients, OR 0.4 (95% CI 0.1-1.4), p = 0.15). The course of HGS, body weight, appetite and nausea did not differ between the groups (p = 0.29, p = 0.14, p = 0.65 and p = 0.94, respectively). The per protocol analysis including 178 patients showed similar results. CONCLUSION Within this controlled trial setting, we found a high compliance for ONS intake and high coverage of protein requirements but no further improvement when ONS was administered using MEDPass compared to conventional care. MEDPass administration may provide an alternative that is easy to integrate into nursing routines, which may lead to lower workload with cost benefits and reduction of food waste. TRIAL REGISTRATION ClinicalTrials.gov: NCT03761680

Mangelernährung im Zeitalter von DRG

Malnutrition in hospital patients is of important medical and economic significance. The adverse consequences of malnutrition on quality of life and many more factors such as morbidity, mortality, tolerance of treatments and length of hospital stay are well documented in the medical literature. Nevertheless, the effects of malnutrition are still often underestimated and hence malnutrition is not recognised as a distinct diagnosis. Moreover, malnutrition is rarely documented in medical reports and often not adequately treated with adverse effects. The reason for this neglectfulness are diverse, e. g. inadequate training of doctors and nurses in clinical nutrition and lack of sensibilisation of the hospital staff for the problem of malnutrition. Therefore, a systematic screening for malnutrition is rarely undertaken in Swiss hospitals. The introduction of the Swiss-DRG system (DRG, diagnosis related groups) in January 2012 gave the chance to boost recording and to document malnutrition in a standardised way in the patient history, and to code precisely malnutrition as a distinct diagnosis. Moreover, this approach allowed to document the specific nutritional therapy. Here, we describe the way of documenting and coding malnutrition in the Swiss-DRG system and the medical and economic consequences of this procedure

Challenges and Efficacy of a Clinical Nutrition Support Team

Ernährungsteams sind Einrichtungen in Krankenhäusern, die sowohl für den fachgerechten Einsatz von enteralen und parenteralen stationären Ernährungstherapien als auch für die Beratung zur ambulanten Ernährung zuständig sind. Im vorliegenden Beitrag wird näher auf die Organisation, die Zusammensetzung, die Aufgaben und Herausforderungen eines klinischen Ernährungsteams betreffend Patienten-Outcome und Kosten eingegangen.Many patients are malnourished at hospital admission. This condition further worsens improve during the hospitalisation. Malnutrition itself prolongs the length of hospital stay and the rehabilitation time, increases complication rates, morbidity, and mortality. Prompt reaction is needed to prevent these negative consequences, to maximise the success of therapy and to offer patients a better quality of life and a maintained autonomy. The early recognition of a poor nutritional status is therefore indispensable to initiate an efficient and timely nutritional therapy, according to individual needs. Multidisciplinary knowledge is needed to avoid potential complications as well as clearly defined responsibilities and structured processes. Thus, inter- and multiprofessional efforts clinical nutrition support teams have been created since the 70ies, mainly in the larger hospitals, to manage nutritional therapies. The main task of a clinical nutrition support team is to detect the risk for malnutrition, to prevent malnutrition by targeted measures and, when appropriate, to adequately treat it quickest possible. In the following, we will provide more details about organisation, composition, tasks, challenges of clinical nutrition support teams as wells as efficacy regarding patients’ outcome and briefly about costs

KODIERUNG DER MANGELERNÄHRUNG IN DER CH: WIRKSAM UND EFFIZIENT

Introduction: Die krankheitsassoziierte Mangelernährung (KAM) ist in Schweizer Spitälern ein häufiges Problem (20 – 50% der Hospitalisierten[i]) mit weitreichenden medizinischen und ökonomischen Folgen. Im SwissDRG-System erbringt die Kodierung der KAM nur bei gewissen Fällen einen Mehrerlös; bei der Mehrheit gibt es trotz ernährungstherapeutischem Aufwand keinen. Objectives: Die vorliegende 4-Jahres-Analyse soll zeigen, ob der Mehrerlös durch die Kodierung der KAM resp. einer E4_ Diagnose kostendeckend ist. Dazu wird dargelegt, bei welchen Patientengruppen besonders oft eine KAM-Diagnose vorliegt. Methods: In dieser retrospektiven Datenerhebung wurden alle stationären Patienten im Inselspital Bern mit einer E4_ Diagnose (E40 – E46) in den Jahren 2013 bis 2016 analysiert. Betrachtet wurden die Hauptdiagnose, die Hospitalisationsdauer, die Art der KAM-Therapie, der Mehrerlös und die Kosten. Der Aufwand für die Ernährungsberatung, Pflege und Ernährungstherapie (Zwischenmahlzeiten, orale Nahrungssupplemente (ONS), Sondenkost, parenterale Nährlösungen, Material etc.) wurde hochgerechnet. Die Patienten wurden aufgrund ihrer Haupt-Diagnose in 12 Gruppen eingeteilt, die auf der ICD-10 Klassifikation der WHO beruhen. Neugeborene und Kinder wurden separat eingeteilt. Results: Von den stationären Patienten (n = 169.515) in den 4 Jahren wurden insgesamt 5.442 Fälle (3,2%) mit KAM kodiert. Davon waren 462 Fälle (8,5%) erlösrelevant. Von den 5.442 Patienten erhielten 3.211 (59%) ONS, 1.578 (29%) enterale Ernährung und 653 (12%) parenterale Ernährung. Die Kodierung der KAM ergab einen Mehrerlös von EUR 3.283.700 und einen Aufwand von EUR 2.634.600. Die erlösrelevanten Fälle wurden mehrheitlich mit leichter und mittelschwerer KAM kodiert. Die durchschnittliche Hospitalisationsdauer betrug 20,4 (± 19,8) Tage, diejenige der DRG-relevanten nur 11,8 (± 7,3) Tage. Am häufigsten mit KAM kodiert wurden onkologische Patienten (n = 1708, 31,4%), gefolgt von Patienten mit Krankheiten des Verdauungssystems (n = 671, 12,3%) und des Kreislaufsystems (n = 609, 11,2%). Der Anteil der Kinder betrug 4,9% (n = 267). Conclusion: Diese Analyse zeigt, dass der Mehrerlös durch die Kodierung der KAM im SwissDRG-System den finanziellen Aufwand für die ernährungstherapeutischen Behandlungen deckt. Die konsequente Erfassung, Behandlung und Kodierung der KAM führt zu einer hohen Behandlungsqualität und ist zudem kosteneffizient

Auswirkung der Kodierung der Mangelernährung im SwissDRG-System

Abstract Background Disease-related malnutrition (DRM) in hospitals is a frequent problem with medical and economic consequences. The present four-years-analysis shows whether the expenses for nutritional therapies of malnourished patients get covered by the surplus, which is attained from the encoding of DRM in the SwissDRG-system. Material and Methods All inpatients with an E 4-diagnosis of the University Hospital of Bern were analyzed in this data collection (2013 – 2016). The E-diagnosis, diagnosis, length of hospital stay, age, type of nutritional therapy, surplus and costs generated by the nutritional treatment were considered. The expenses for the nutrition counseling, care and nutritional therapies were extrapolated. Further, the patients were divided into 12 groups (based on the ICD-10 classification of the WHO), due to their principal diagnosis. Results Of the 169515 inpatients in the observed four years, 5442 cases (3.2 %) were coded as malnourished. Only 462 cases (8.5 %) increased the relative weight, and hence, the amount of total reimbursement of the assigned DRM. Of the 5442 patients, 3211 (59 %) received oral nutritional supplements, 1578 (29 %) enteral nutrition and 654 (12 %) parenteral nutrition. The encoding of DRM amounted to a surplus of total CHF 3 494 081 and an effort of extrapolated CHF 2 803 432. Oncological patients were most often encoded with DRM (n = 1708, 31.4 %), followed by patients with diseases of the digestive system (n = 671, 12.3 %) and of the circulatory system (n = 609, 11.2 %). Conclusion This analysis shows, that the surplus generated by the encoding of DRM in the SwissDRG-system, covers the financial effort resulting from nutritional therapies. The consequent and early assessment, treatment and encoding of DRM lead to a high treatment quality and patient safety and is economically viable for the hospital

Individualized Nutritional Support versus Usual Care in Medical Inpatients at Risk of Malnutrition: Randomized Trial

Objective To evaluate if medical inpatients at risk of malnutrition benefit from an individualized nutritional intervention in terms of clinical outcome Design Single-centre randomized controlled trial Setting All inpatients admitted to the Division of General Internal Medicine at a Swiss University Hospital Participants Screened patients with risk of malnutrition defined by a Nutritional Risk Screening (NRS 2002) total score of ≥3. Patients with severe organ malfunction or short life expectancy were excluded. Interventions Enrolled patients were randomly allocated (1:1) to receive individualized nutritional support or usual care. Both groups received standard hospital meals. In the intervention group, the target was to ensure an oral, enteral or parenteral intake above 75% of the estimated energy requirements. Outcome measures Length of hospital stay was the powered primary endpoint. Pre-specified secondary endpoints included quality of life, readmissions, death, and the composite of death or protocol-specified complications. Results A total of 2207 admitted patients were screened and 263 randomized, 121 patients to the intervention, and 142 to usual care. In the intervention group, 59% of patients reached their caloric goals, compared to 40% in the control group. There were no significant differences between groups in length of hospital stay (HR 0.94, 95% CI 0.72, 1.22), death (HR 1.07, 95% CI 0.54, 2.09), readmissions (HR 1.09, 95% CI 0.61, 1.98), the composite of death or protocol-specified complications up to 8 weeks (HR 0.88, CI 95% 0.49, 1.58) or quality of life. Conclusions We found no evidence for a benefit of individualized nutritional support on length of stay, quality of life, death, readmissions, or the composite of death or protocol-specified complications up to 8 weeks in medical inpatients at risk of malnutrition admitted to a university hospital