Effect of Early Nutritional Therapy on Frailty, Functional Outcomes and Recovery of Undernourished Medical Inpatients Trial: The EFFORT Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Malnutrition
- Sponsor
- University Hospital, Basel, Switzerland
- Enrollment
- 2088
- Locations
- 1
- Primary Endpoint
- primary composite endpoint
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The aims of the randomized-controlled, multicenter EFFORT trial are to assess the effects of early nutritional therapy in regard to effectiveness, safety and costs when applied to the heterogenous, polymorbid medical inpatient population. EFFORT will not only answer the question about overall benefit or harm, but using a physio-pathological mechanistic approach, it also will explore and provide conclusive answers about whether, why, how, and in which patient populations nutritional therapy does and does not works.
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%.
Investigators
Philipp Schuetz
Prof. Dr. med.
University Hospital, Basel, Switzerland
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
primary composite endpoint
Time Frame: measured at day 30 by telephone interview
Number of participants with adverse events including 1. All-cause mortality 2. Admission to the intensive care unit 3. Unplanned hospital readmission after hospital discharge 4. Major complications including nosocomial infection or abscess requiring antibiotic treatment, respiratory failure with need for invasive or non-invasive ventilation, major cardiovascular event or pulmonary embolism, acute renal failure (defined by 2x increase of baseline creatinine or new requirement of dialysis), gastro-intestinal hemorrhage or intestinal perforation assessed by medical chart review and telephone interview 5. decline in functional status of 10% or more from admission to day 30 measured by the Barthel's index assessed by patient interview on admission and after 30 days
Secondary Outcomes
- Weight change(measured at day 30 by telephone interview)
- lenght of hospital stay(participants will be followed for the duration of hospital stay with an expected average of 10 days)
- Improvement in quality of life(measured at days 30 and 180 by telephone interview)
- new decubital ulcer(assessed on the day of hospital discharge after an expected average of 10 days)
- Combined safety endpoints in regard to side effects from nutritional therapy(measured at day 30)
- Discharge location(assessed on the day of hospital discharge after an expected average of 10 days)