Design and rationale of the effect of early nutritional therapy on frailty, functional outcomes and recovery of malnourished medical inpatients (EFFORT): a pragmatic, multicenter, randomized-controlled trial - Protocol.

Schuetz, Philipp; Fehr, Rebecca; Baechli, Valerie; Geiser, Martina; Gomes, Filomena; Kutz, Alexander; Tribolet, Pascal; Bregenzer, Thomas; Hoess, Claus; Pavlicek, Vojtech; Schmid, Sarah; Bilz, Stefan; Sigrist, Sarah; Brändle, Michael; Benz, Carmen; Henzen, Christoph; Mattmann, Silvia; Thomann, Robert; Brand, Claudia; Rutishauser, Jonas; ... (2018). Design and rationale of the effect of early nutritional therapy on frailty, functional outcomes and recovery of malnourished medical inpatients (EFFORT): a pragmatic, multicenter, randomized-controlled trial - Protocol. International Journal of Clinical Trials, 5(3), pp. 142-50. Medip Academy 10.18203/2349-3259.ijct20182085

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Background: Malnutrition is highly prevalent and strongly associated with clincial outcomes of medical inpatients. Still, the benefit of nutritional treatment to prevent adverse outcomes in medical inpatients at risk for malnutrition remains unproven. We describe the trial methods of the largest yet nutritional trial in medical inpatients including the rationale for key design decisions regarding the nutritional strategy, eligibility criteria, choice of control arm, and endpoints. Methods: The Effect of early nutritional therapy on Frailty, Functional Outcomes and Recovery of malnourished medical inpatients Trial (EFFORT) is an investigator-initiated, non-commercial, open-label RCT to compare the effects of an intensified nutritional therapy (intervention group) with a control group on medical outcomes. We include adult medical inpatients at risk of malnutrition based on a Nutritional Risk Screening 2002 (NRS) score of ≥3 points with an expected length of stay of ≥5 days. An individualized systematic nutritional assessment by study dieticians is done to define nutritional targets and to establish an implementation plan. Patients in the intervention group receive individualized early nutritional therapy based on a previously published consensus algorithm, while control group patients receive standard hospital nutrition. The study is powered to compare clinical outcomes (composite adverse outcome and mortality) in the 2 study arms as well as to address several mechanistical questions. Conclusion: EFFORT aims to close important gaps in the literature regarding the controversy about benefit and possible harm of nutritional therapy in medical inpatients at risk for malnutrition.

Item Type:

Journal Article (Further Contribution)

Division/Institute:

04 Faculty of Medicine > Department of Gynaecology, Paediatrics and Endocrinology (DFKE) > Clinic of Endocrinology, Diabetology and Clinical Nutrition
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine > Centre of Competence for General Internal Medicine
04 Faculty of Medicine > Medical Education > Institute of General Practice and Primary Care (BIHAM)

UniBE Contributor:

Aujesky, Drahomir; Rodondi, Nicolas; Donzé, Jacques and Stanga, Zeno

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

2349-3240

Publisher:

Medip Academy

Language:

English

Submitter:

Doris Kopp Heim

Date Deposited:

12 Jun 2018 11:09

Last Modified:

07 Feb 2019 13:21

Publisher DOI:

10.18203/2349-3259.ijct20182085

BORIS DOI:

10.7892/boris.117157

URI:

https://boris.unibe.ch/id/eprint/117157

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