Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery

Официальное название

Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery Trial: The EFFORT II Project

Обзор

This study is to compare the sustained post-discharge nutritional support to reach individual energy and protein goals to usual care home nutrition in medical patients at nutritional risk.

Подробное описание

Malnutrition is a strong and independent long-term risk factor for mortality, rehospitalisation and functional decline, particularly in the elderly, polymorbid medical patient population. The randomized-controlled Effect of early nutritional support on Frailty, Functional Outcomes and Recovery of malnourished medical inpatients Trial (EFFORT, Lancet 2019) included 2028 patients in eight Swiss hospitals and found that nutritional support during the inhospital stay reduces very efficiently the risk for complications and mortality with numbers needed to treat (NNT) of 23 and 37, respectively.

Yet, the nutritional intervention was not continued after hospital discharge of patients and long-term follow-up data of patients showed a lack of sustained effect of the initial nutritional support strategy. There is a current lack of trial data investigating whether long-term use of nutritional support has a sustained effect on clinical outcomes in this patient population. This study is to compare the continuous use of nutritional support with the use of approved oral nutritional supplements to reach protein and energy goals and to analyze whether medical patients at nutritional risk show a sustained benefit from long-term nutritional support after hospital discharge, and why and how nutritional support affects the course of disease from a mechanistic physio-pathological standpoint.

Вмешательства

• Пищевая добавка nutritional supplement
  daily use of one or more specific oral nutritional supplement with high energy/protein content (i.e., Resource Ultra, Resource 2.0 (Fibre), Resource Ultra Fruit).
• Другое individualized nutritional guidelines
  nutritional plan supervised by an experienced study dietician based on the usual home nutrition with possibility to increase intake by adaptation to patient preferences, between meal snaking and food enrichment/fortification. Every 2-4 weeks phone call by unblinded study dietician to follow nutritional intervention.
• Другое general nutritional information
  general information about health food behavior upon hospital discharge

Первичные конечные точки

• time to death from any cause (i.e., all-cause mortality) [Срок оценки: Enrollment to 3 years]

Вторичные конечные точки (5)

• Time to non-elective hospital readmission after discharge from the index hospital stay [Срок оценки: assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]]
• Time to the first major complication [Срок оценки: assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]]
• Changes in functional status measured by the Barthel's index [Срок оценки: assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]]
• Changes in quality of life measured with the European Quality of Life 5 Dimensions index (German Version, EQ-5D index) [Срок оценки: assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]]
• Changes in quality of life measured with the visual-analogue scale (EQ-5D VAS) [Срок оценки: assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]]

Критерии участия

Критерии включения

• Informed Consent as documented by signature
• Adult (age ≥18 years), medical patients
• Nutritional risk screening using the Nutritional Risk Screening (NRS): total score ≥3 points consisting of ≥1 points for impairment of the nutritional status \[weight loss >5% in 3 month or food intake of 50-75% in the last week before hospital admission\] plus ≥1 for the severity of the disease (i.e., cancer, chronic kidney disease, chronic heart failure, COPD) and other chronic diseases according to the definition of the "National Center for Chronic Disease Prevention and Health Promotion": Chronic diseases are defined broadly as conditions that last 1 year or more and require ongoing medical attention or limit activities of daily living or both .

Критерии исключения

• after surgery
• unable to ingest oral nutrition
• need for long-term nutrition,
• terminal condition
• acute pancreatitis or acute liver failure
• patients discharged to a nursing home
• patients unlikely to comply with nutritional support treatment (e.g., dementia)
• COVID-Hospitalisation requiring intensive care

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Швейцария · 12 центров

• Spital Zofingen — Zofingen
• Spital Emmental Burgdorf — Burgdorf
• Spital Thun — Thun
• Spital Lachen — Lachen
• Kantonsspital Münsterlingen — Münsterlingen
• Kantonsspital Aarau, University Department of Internal Medicine — Aarau
• Bern University Hospital, Department of General Internal Medicine — Bern
• Kantonsspital Lucerne, Department of Internal Medicine — Lucerne
• … и ещё 4 центра

Испания · 6 центров

• Hospital Universitari Vall Hebron de Barcelona — Barcelona
• Hospital Universitario de Getafe — Getafe
• Complejo AComplejo Asistencial Universitario de León — León
• Hospital U. Gregorio Marañón de Madrid — Madrid
• Hospital Universitario Regional de Málaga — Málaga
• Hospital Clínico Universitario de Valladolid — Valladolid

Публикации

• Wunderle C, Tribolet P, Kaegi-Braun N, Haller V, Escher R, Aujesky D, Trennepohl Da Costa Heinen G, Brandle M, Bregenzer T, Henzen C, Zehnder T, Schait S, Gassmann C, Dorfschmid M, Ballesteros-Pomar MD, Cuerda C, Burgos R, De Luis D, Olveira G, Rodriguez-Manas L, Stanga Z, Mueller B, Schuetz P. Design and rationale of the EFFORTII project: a multicentric randomised-controlled trial on the impact o PMID 41857825

Идентификаторы

NCT: NCT04926597 · 2021-00278; ex20Schuetz

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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