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

Not Applicable

Recruiting

• Conditions: Malnutrition
• Interventions: Dietary Supplement: nutritional supplement; Other: general nutritional information; Other: individualized nutritional guidelines

• Registration Number: NCT04926597
• Lead Sponsor: Philipp Schuetz

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.

Study Timeline

• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-08
• Study First Posted: 2021-06-15
• Study Start: 2021-08-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group: individualized nutritional support	individualized nutritional guidelines	Intervention group patients will receive individualized nutritional support to reach energy and protein goals with the support of an experienced, unblinded dietician and with use of oral nutritional supplements (ONS) as needed
Intervention group: individualized nutritional support	nutritional supplement	Intervention group patients will receive individualized nutritional support to reach energy and protein goals with the support of an experienced, unblinded dietician and with use of oral nutritional supplements (ONS) as needed
Control group: general information on healthy food habits	general nutritional information	Control group patients will receive nutritional counselling (general information on healthy food habits) at discharge, but no nutritional support strategy will be used during follow-up

Primary Outcome Measures

Name	Time	Method
time to death from any cause (i.e., all-cause mortality)	Enrollment to 3 years	time to death from any cause (i.e., all-cause mortality)

Secondary Outcome Measures

Name	Time	Method
Time to non-elective hospital readmission after discharge from the index hospital stay	assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]	Time to non-elective hospital readmission after discharge from the index hospital stay
Time to the first major complication	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 including death, bacterial infection with need for antibiotic treatment, major cardiovascular event (i.e., stroke, intracranial bleeding, cardiac arrest, myocardial infarction) or pulmonary embolism, acute renal failure, gastro-intestinal events (including hemorrhage, intestinal perforation, acute pancreatitis)
Changes in functional status measured by the Barthel's index	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 (scores range from 0 to 100, with higher scores indicating better functional status)
Changes in quality of life measured with the European Quality of Life 5 Dimensions index (German Version, EQ-5D index)	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 values range from 0 to 1, with higher scores indicating better quality of life)
Changes in quality of life measured with the visual-analogue scale (EQ-5D VAS)	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) (scores range from 0 to 100, with higher scores indicating better health status).

Trial Locations

Locations (18)

Hospital Universitari Vall Hebron de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario de Getafe; 🇪🇸 Getafe, Spain

Complejo AComplejo Asistencial Universitario de León; 🇪🇸 León, Spain

Hospital U. Gregorio Marañón de Madrid; 🇪🇸 Madrid, Spain

Hospital Universitario Regional de Málaga; 🇪🇸 Málaga, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Spital Zofingen; 🇨🇭 Zofingen, Aargau, Switzerland

Spital Emmental Burgdorf; 🇨🇭 Burgdorf, Bern, Switzerland

Spital Thun; 🇨🇭 Thun, Bern, Switzerland

Spital Lachen; 🇨🇭 Lachen, Schwyz, Switzerland

Kantonsspital Münsterlingen; 🇨🇭 Münsterlingen, Thurgau, Switzerland

Kantonsspital Aarau, University Department of Internal Medicine; 🇨🇭 Aarau, Switzerland

Bern University Hospital, Department of General Internal Medicine; 🇨🇭 Bern, Switzerland

Kantonsspital Lucerne, Department of Internal Medicine; 🇨🇭 Lucerne, Switzerland

Kantonsspital Sankt Gallen; 🇨🇭 Sankt Gallen, Switzerland

Klinik Hirslanden Zürich; 🇨🇭 Zürich, Switzerland

Stadtspital Zürich; 🇨🇭 Zürich, Switzerland

Universitätsspital Zürich; 🇨🇭 Zürich, Switzerland