Clinical trial NCT04926597: Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery
Official title: Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery Trial: The EFFORT II Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malnutrition
Keywords: Nutritional Support
Oral Nutritional Supplements
Frailty
Mortality
Morbidity
Lead sponsor: Kantonsspital Aarau
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic, single blinded, open label randomised-controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 .

Exclusion Criteria:

* 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

Primary outcomes:
measure: time to death from any cause (i.e., all-cause mortality)
timeFrame: Enrollment to 3 years
Secondary outcomes:
measure: Time to non-elective hospital readmission after discharge from the index hospital stay
timeFrame: assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]
measure: Time to the first major complication
timeFrame: assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]
measure: Changes in functional status measured by the Barthel's index
timeFrame: assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]
measure: Changes in quality of life measured with the European Quality of Life 5 Dimensions index (German Version, EQ-5D index)
timeFrame: assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]
measure: Changes in quality of life measured with the visual-analogue scale (EQ-5D VAS)
timeFrame: assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]
Other outcomes:
measure: Change in body weight
timeFrame: assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits
measure: Change in calf circumference to assess muscle mass
timeFrame: assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits
measure: Change in bioelectrical impedance analysis (BIA) to assess body composition
timeFrame: assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits
measure: Change in hand grip by means of handgrip strength through dynamometry (North Coast Medical Exacta™ Hydraulic Hand Dynamometer) to assess muscle strength
timeFrame: assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall Hebron de Barcelona
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
city: León
country: Spain
facility: Complejo AComplejo Asistencial Universitario de León
city: Madrid
country: Spain
facility: Hospital U. Gregorio Marañón de Madrid
city: Málaga
country: Spain
facility: Hospital Universitario Regional de Málaga
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Zofingen
country: Switzerland
facility: Spital Zofingen
state: Aargau
city: Burgdorf
country: Switzerland
facility: Spital Emmental Burgdorf
state: Bern
city: Thun
country: Switzerland
facility: Spital Thun
state: Bern
city: Lachen
country: Switzerland
facility: Spital Lachen
state: Schwyz
city: Münsterlingen
country: Switzerland
facility: Kantonsspital Münsterlingen
state: Thurgau
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau, University Department of Internal Medicine
city: Bern
country: Switzerland
facility: Bern University Hospital, Department of General Internal Medicine
city: Lucerne
country: Switzerland
facility: Kantonsspital Lucerne, Department of Internal Medicine
city: Sankt Gallen
country: Switzerland
facility: Kantonsspital Sankt Gallen
city: Zürich
country: Switzerland
facility: Klinik Hirslanden Zürich
city: Zürich
country: Switzerland
facility: Stadtspital Zürich
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Kantonsspital Aarau, University Department of Internal Medicine
name: Philipp Schuetz, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: