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

Malnutrition Clinical Trial

— EFFORT II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04926597
• Other study ID #: 2021-00278; ex20Schuetz
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2021
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Kantonsspital Aarau
• Contact: Philipp Schuetz, Prof. Dr. med.
• Phone: +41 (0) 62 838 9524
• Email: Philipp.Schuetz[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 802
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Malnutrition

Intervention

Dietary Supplement:
• 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).

Other:
• 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.
• general nutritional information
general information about health food behavior upon hospital discharge

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau, University Department of Internal Medicine	Aarau
Switzerland	Bern University Hospital, Department of General Internal Medicine	Bern
Switzerland	Spital Emmental Burgdorf	Burgdorf	Bern
Switzerland	Spital Lachen	Lachen	Schwyz
Switzerland	Kantonsspital Lucerne, Department of Internal Medicine	Lucerne
Switzerland	Kantonsspital Münsterlingen	Münsterlingen	Thurgau
Switzerland	Kantonsspital Sankt Gallen	Sankt Gallen
Switzerland	Spital Thun	Thun	Bern
Switzerland	Spital Zofingen	Zofingen	Aargau
Switzerland	Klinik Hirslanden Zürich	Zürich
Switzerland	Stadtspital Zürich	Zürich
Switzerland	Universitätsspital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Philipp Schuetz

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in body weight	Change in body weight	assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits
Other	Change in calf circumference to assess muscle mass	Change in calf circumference to assess muscle mass	assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits
Other	Change in bioelectrical impedance analysis (BIA) to assess body composition	Change in bioelectrical impedance analysis (BIA) to assess body composition	assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits
Other	Change in hand grip by means of handgrip strength through dynamometry (North Coast Medical Exacta™ Hydraulic Hand Dynamometer) to assess muscle strength	Change in hand grip by means of handgrip strength through dynamometry (North Coast Medical Exacta™ Hydraulic Hand Dynamometer) to assess muscle strength	assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits
Primary	time to death from any cause (i.e., all-cause mortality)	time to death from any cause (i.e., all-cause mortality)	Enrollment to 3 years
Secondary	Time to non-elective hospital readmission after discharge from the index hospital stay	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)]
Secondary	Time to the first major complication	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)	assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]
Secondary	Changes in functional status measured by the Barthel's index	Changes in functional status measured by the Barthel's index (scores range from 0 to 100, with higher scores indicating better functional status)	assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]
Secondary	Changes in quality of life measured with the European Quality of Life 5 Dimensions index (German Version, EQ-5D index)	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)	assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]
Secondary	Changes in quality of life measured with the visual-analogue scale (EQ-5D VAS)	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).	assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]