- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02517476
Effect of Early Nutritional Therapy on Frailty, Functional Outcomes and Recovery of Undernourished Medical Inpatients Trial (EFFORT)
Effect of Early Nutritional Therapy on Frailty, Functional Outcomes and Recovery of Undernourished Medical Inpatients Trial: The EFFORT Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aims of the randomized-controlled, multicenter EFFORT trial are to test the hypothesis that in medical inpatients at risk for undernutrition defined by the nutritional risk score (NRS 2002), early tailored nutritional therapy to reach nutritional targets based on individualized nutritional counseling is a cost-effective strategy to prevent mortality, morbidity and functional decline.
The primary composite endpoint is combined adverse outcome within 30 days defined as (a) all-cause mortality, (b) admission to the intensive care unit from the medical ward, (c) major complications, (d) unplanned hospital readmissions and (d) decline in functional outcome from admission to day 30 assessed by Barthel's index (-10%). Secondary endpoints include (a) each single component of the primary endpoint (b) short-term nutritional and functional outcomes from inclusion to day 10 or hospital discharge; (c) hospital outcomes; (d) 30-day and 180-day outcomes (e) Other safety endpoints including adverse gastrointestinal effects associated with nutritional therapy assessed daily until hospital discharge.
The investigators will include unselected adult medical inpatients at risk of undernutrition [NRS≥3 points] and an expected hospital stay of ≥5 days who are willing to provide informed consent. The investigators will exclude patients in critical care or post-operative state, unable to swallow, at long-term need for parenteral/enteral nutrition, in terminal condition, pregnant, with acute pancreatitis or acute liver failure, with anorexia nervosa, that were earlier included into the trial Patients in the intervention group will receive individualized nutritional therapy to reach nutritional targets (caloric, protein, micronutrients, other) based on a predefined nutritional strategy. In control patients, according to patients' appetite, standard hospital nutrition will be served. Nutritional therapy may be started in control patients, if any sort of swallowing disorders develops or if patients need to be prepared for operation. All patients will be re-assessed daily during the hospital stay for nutritional intake and nutritional therapy may be escalated every 24-48 hours (food fortification, oral supplements, enteral, parenteral nutrition) if targets are not met (at least 75% of targets).
The targeted sample size is 2000 - 3000 patients. The inclusion of 2000 - 3000 patients will provide between 76% and 91% power to detect a reduction in the primary endpoint of 15% (from 40% to 34%) assuming a lost to follow up rate of 10%.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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AG
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Aarau, AG, Switzerland, 5000
- University Clinic, Kantonsspital Aarau
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- NRS ≥3 points
- expected hospital LOS ≥5 days (as estimated by the treating physician team)
- willingness to provide informed consent (see informed consent statement)
Exclusion criteria
- initially admitted to critical care units (except intermediate care)
- scheduled for surgery or in an immediate post-operative state
- unable to ingest oral nutrition and thus need for enteral or parenteral nutrition
- admitted with, or scheduled for, total parenteral nutrition or tube feeding
- currently under nutritional therapy (defined by at least one visit with a dietician in the last month)
- who are hospitalized because of anorexia nervosa
- in terminal condition (end of life situation)
- hospitalized due to acute pancreatitis
- hospitalized due to acute liver failure
- earlier inclusion into this trial
- cystic fibrosis
- patients after gastric bypass operations
- stem cell transplantation
- any contraindication against nutritional therapy (i.e., enteral and/or parenteral)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nutritional support
For the purpose of this study, we have developed nutritional guidelines by consensus and adapted to current guidelines (e.g., ESPEN, ASPEN).
These guidelines specify a reinforced nutritional therapy strategy to cover nutritional requirements, focusing on nutritional targets based on the specific nutritional diagnoses defined by the IDNT.
The nutritional guidelines may vary according to important medical diagnoses (i.e.
renal failure).
They specify not only nutritional targets, but also escalation of the route (i.e.
food fortification, oral, enteral, parenteral) if targets cannot be achieved (≤75%) every 5 hours.
Nutritional goals are being assessed daily in patients in the intervention group.
|
Any nutritional product and route (i.e.
food fortification, oral, enteral, parenteral) is possible to reach goals
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No Intervention: Usual care ("appetite-guided") controls
In control patients, we will use conventional nutrition according to the ability and desire of the patient to eat, using standard care food provided by the hospital kitchen ("appetite-guided").
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
primary composite endpoint
Time Frame: measured at day 30 by telephone interview
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Number of participants with adverse events including
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measured at day 30 by telephone interview
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight change
Time Frame: measured at day 30 by telephone interview
|
change in weight and BMI from inclusion to day 30 by patient interview and medical chart review
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measured at day 30 by telephone interview
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lenght of hospital stay
Time Frame: participants will be followed for the duration of hospital stay with an expected average of 10 days
|
days in the hospital within index hospitalisation and within the 30 days of follow up measured by patient interview and medical chart review
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participants will be followed for the duration of hospital stay with an expected average of 10 days
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Improvement in quality of life
Time Frame: measured at days 30 and 180 by telephone interview
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Improvement in quality of life measured with the EuroQol Group 5-Dimension Self-Report Questionnaire on admission and during follow up measured by patient interview
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measured at days 30 and 180 by telephone interview
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Combined safety endpoints in regard to side effects from nutritional therapy
Time Frame: measured at day 30
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Number of participants with side effects from nutritional therapy including (a) adverse gastrointestinal effects (diarrhea, nausea, vomiting, abdominal pain) assessed by patient interview (yes/no) b) Complications due to tube feeding or center catheter for parenteral nutrition assessed by medical chart review (c) Refeeding syndrome assessed by chart review (d) Acute pancreatitis defined as 2 out of 3 criteria: abdominal pain, 3-fold increase in lipase or amylase, characteristic imaging findings assessed by chart review (e) Liver or gall bladder dysfunction assessed by chart review (f) Hyperglycemia (defined as glucose levels >12mmol/l or persistent levels >10mmol/l in patients without diabetes or well controlled diabetes) assessed by medical chart review |
measured at day 30
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new decubital ulcer
Time Frame: assessed on the day of hospital discharge after an expected average of 10 days
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Clinical diagnosis of decubital ulcer with onset after study inclusion measured by patient interview and medical chart review
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assessed on the day of hospital discharge after an expected average of 10 days
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Discharge location
Time Frame: assessed on the day of hospital discharge after an expected average of 10 days
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proportion discharge home or to a rehab facility measured by patient interview and medical chart review
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assessed on the day of hospital discharge after an expected average of 10 days
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Philipp Schuetz, Prof. Dr., University Clinic, Kantonsspital Aarau
Publications and helpful links
General Publications
- Schuetz P. "Eat your lunch!" - controversies in the nutrition of the acutely, non-critically ill medical inpatient. Swiss Med Wkly. 2015 Apr 23;145:w14132. doi: 10.4414/smw.2015.14132. eCollection 2015.
- Schutz P, Bally M, Stanga Z, Keller U. Loss of appetite in acutely ill medical inpatients: physiological response or therapeutic target? Swiss Med Wkly. 2014 Apr 29;144:w13957. doi: 10.4414/smw.2014.13957. eCollection 2014.
- Stalder L, Kaegi-Braun N, Gressies C, Gregoriano C, Tribolet P, Lobo DN, Gomes F, Hoess C, Pavlicek V, Bilz S, Sigrist S, Brandle M, Henzen C, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B, Schuetz P. Prospective validation of five malnutrition screening and assessment instruments among medical inpatients: Secondary analysis of a randomized clinical trial. Clin Nutr. 2022 Jun;41(6):1307-1315. doi: 10.1016/j.clnu.2022.04.025. Epub 2022 Apr 26.
- Struja T, Laczko E, Wolski W, Schlapbach R, Mueller B, Roschitzki B, Schuetz P. Association of proteomic markers with nutritional risk and response to nutritional support: A secondary pilot study of the EFFORT trial using an untargeted proteomics approach. Clin Nutr ESPEN. 2022 Apr;48:282-290. doi: 10.1016/j.clnesp.2022.01.035. Epub 2022 Feb 2.
- Kaegi-Braun N, Boesiger F, Tribolet P, Gomes F, Kutz A, Hoess C, Pavlicek V, Bilz S, Sigrist S, Brandle M, Henzen C, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Lobo DN, Cederholm T, Mueller B, Schuetz P. Validation of modified GLIM criteria to predict adverse clinical outcome and response to nutritional treatment: A secondary analysis of a randomized clinical trial. Clin Nutr. 2022 Apr;41(4):795-804. doi: 10.1016/j.clnu.2022.02.009. Epub 2022 Feb 17.
- Bretschera C, Boesiger F, Kaegi-Braun N, Hersberger L, Lobo DN, Evans DC, Tribolet P, Gomes F, Hoess C, Pavlicek V, Bilz S, Sigrist S, Brandle M, Henzen C, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B, Schuetz P. Admission serum albumin concentrations and response to nutritional therapy in hospitalised patients at malnutrition risk: Secondary analysis of a randomised clinical trial. EClinicalMedicine. 2022 Feb 11;45:101301. doi: 10.1016/j.eclinm.2022.101301. eCollection 2022 Mar.
- Hersberger L, Dietz A, Burgler H, Bargetzi A, Bargetzi L, Kagi-Braun N, Tribolet P, Gomes F, Hoess C, Pavlicek V, Bilz S, Sigrist S, Brandle M, Henzen C, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B, Schuetz P. Individualized Nutritional Support for Hospitalized Patients With Chronic Heart Failure. J Am Coll Cardiol. 2021 May 11;77(18):2307-2319. doi: 10.1016/j.jacc.2021.03.232.
- Bargetzi A, Emmenegger N, Wildisen S, Nickler M, Bargetzi L, Hersberger L, Segerer S, Kaegi-Braun N, Tribolet P, Gomes F, Hoess C, Pavlicek V, Bilz S, Sigrist S, Brandle M, Henzen C, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B, Schuetz P. Admission kidney function is a strong predictor for the response to nutritional support in patients at nutritional risk. Clin Nutr. 2021 May;40(5):2762-2771. doi: 10.1016/j.clnu.2021.03.013. Epub 2021 Mar 15.
- Kaegi-Braun N, Tribolet P, Baumgartner A, Fehr R, Baechli V, Geiser M, Deiss M, Gomes F, Kutz A, Hoess C, Pavlicek V, Schmid S, Bilz S, Sigrist S, Brandle M, Benz C, Henzen C, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B, Schuetz P. Value of handgrip strength to predict clinical outcomes and therapeutic response in malnourished medical inpatients: Secondary analysis of a randomized controlled trial. Am J Clin Nutr. 2021 Aug 2;114(2):731-740. doi: 10.1093/ajcn/nqab042. Erratum In: Am J Clin Nutr. 2021 Aug 2;114(2):826-827.
- Baumgartner A, Hasenboehler F, Cantone J, Hersberger L, Bargetzi A, Bargetzi L, Kaegi-Braun N, Tribolet P, Gomes F, Hoess C, Pavlicek V, Bilz S, Sigrist S, Brandle M, Henzen C, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B, Schuetz P. Effect of nutritional support in patients with lower respiratory tract infection: Secondary analysis of a randomized clinical trial. Clin Nutr. 2021 Apr;40(4):1843-1850. doi: 10.1016/j.clnu.2020.10.009. Epub 2020 Oct 10.
- Kaegi-Braun N, Tribolet P, Gomes F, Fehr R, Baechli V, Geiser M, Deiss M, Kutz A, Bregenzer T, Hoess C, Pavlicek V, Schmid S, Bilz S, Sigrist S, Brandle M, Benz C, Henzen C, Mattmann S, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B, Schuetz P. Six-month outcomes after individualized nutritional support during the hospital stay in medical patients at nutritional risk: Secondary analysis of a prospective randomized trial. Clin Nutr. 2021 Mar;40(3):812-819. doi: 10.1016/j.clnu.2020.08.019. Epub 2020 Sep 5.
- Merker M, Felder M, Gueissaz L, Bolliger R, Tribolet P, Kagi-Braun N, Gomes F, Hoess C, Pavlicek V, Bilz S, Sigrist S, Brandle M, Henzen C, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B, Schuetz P. Association of Baseline Inflammation With Effectiveness of Nutritional Support Among Patients With Disease-Related Malnutrition: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e200663. doi: 10.1001/jamanetworkopen.2020.0663.
- Schuetz P, Sulo S, Walzer S, Vollmer L, Stanga Z, Gomes F, Rueda R, Mueller B, Partridge J; EFFORT trial collaborators. Economic evaluation of individualized nutritional support in medical inpatients: Secondary analysis of the EFFORT trial. Clin Nutr. 2020 Nov;39(11):3361-3368. doi: 10.1016/j.clnu.2020.02.023. Epub 2020 Feb 25.
- Schuetz P, Fehr R, Baechli V, Geiser M, Deiss M, Gomes F, Kutz A, Tribolet P, Bregenzer T, Braun N, Hoess C, Pavlicek V, Schmid S, Bilz S, Sigrist S, Brandle M, Benz C, Henzen C, Mattmann S, Thomann R, Brand C, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B. Individualised nutritional support in medical inpatients at nutritional risk: a randomised clinical trial. Lancet. 2019 Jun 8;393(10188):2312-2321. doi: 10.1016/S0140-6736(18)32776-4. Epub 2019 Apr 25.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EKNZ 2014-001
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