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EFFORT Trial

Dr Swapnil Pawar January 13, 2020 67


Background
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Effect of early nutritional support on Frailty, Functional Outcomes, and Recovery of malnourished medical inpatients Trial (EFFORT) trial

EFFORT Trial

Anorexia arises as a physiological response to acute illness and predisposes hospital inpatients to serious caloric and protein deficits. In combination with immobilisation and pronounced inflammatory and endocrine stress response, these nutritional deficits contribute to muscle wasting and progressive deterioration of metabolic and functional status, particularly in medical patients with multiple morbidities.

Hospitals don’t provide the best possible food and often patients complain about the quality of the food. 

More than 30% of medical inpatients are at increased risk of malnutrition, a condition that is strongly associated with increased mortality and morbidity, functional decline, prolonged hospital stays, and increased costs of health care.

What’s known so far? – 

European Society for Clinical Nutrition and Metabolism7 and the American Society for Parenteral and Enteral Nutrition,8 recommend considering placing medical inpatients identified by screening and assessment as being at risk of malnutrition on nutritional support during their hospital stay.

Small trials have found that nutritional support reduced the length of hospital stays and decreased mortality.

Interesting Dilemma – 

EFFORT also has important ethical considerations. After discussions with national experts in the field (ie, trial collaborators) and our ethical review board, we were of the opinion that it was ethically acceptable that patients in the control group received no additional nutritional treatment. This is also in accordance with a previous Swiss consensus ethics statement32 that pointed out that “intake of standard food and fluids is a basic right of any patients”, yet any sort of nutritional therapy must be viewed as a therapeutic measure and must therefore fulfil all criteria for this, including proof of clinical effectiveness, safety, and cost-effectiveness.32 For our population of patients, such proof was still missing and was thus the main aim of this trial.

Setting

Multicenter, randomized, placebo-controlled, double-blind trial conducted across 8 Swiss hospitals. 

Study population

Included: The study included patients aged 18 years or more nutritional risk of 3 or more and expected to stay in hospital for more than 4 days

Not included: Initially admitted to intensive care units or surgical units; patients who were unable eat; were already on nutritional support; patients with a terminal illness; admitted to hospital anorexia nervosa, acute pancreatitis, acute liver failure, cystic fibrosis, stem­cell transplantation; after gastric bypass surgery; with contraindications for nutritional support

Intervention 

Nutritional support was commenced as soon as possible after randomisation, within 48 h after hospital admission. Nutritional goals were individualized by a trained registered dietitian at hospital admission. Caloric requirements were prescribed based on the weight­adjusted Harris­Benedict equation. The daily protein intake was 1·2–1·5 g/kg; patients with acute renal failure received 0·8 g/kg of bodyweight. Initially standard hospital kitchen based food with oral nutritional supplements; if at least 75% of the daily caloric and protein targets could not be met within 5 days, further support through an enteral tube or with TPN. 

Nutritional intake was assessed every 24–48 h 

Oral nutritional supplements if required at discharge 

Control

Standard hospital food was offered based on patient wishes; no additional nutritional support. Following discharge, nutritional support was prescribed at the discretion of the medical and nursing teams

Outcomes

Composite primary outcome: at 30 days  23% vs. 27% OR 0·79 [95% CI 0·64–0·97]. Kaplan Meir curves, significantly shorter time to reach the primary endpoint. 

All-cause mortality: lower risk at 30 days 

Functional decline at day 30 of 10% or greater according to the Barthel index: Lower risk with nutritional support 

ICU admission: No difference 

Non­elective hospital re­admission: No difference 

Hospital LOS: Not different

Major complications (including adjudicated nosocomial infection, respiratory failure, a major cardiovascular event (ie, stroke, intracranial bleeding, cardiac arrest, myocardial infarction, or pulmonary embolism), acute renal failure, gastro-intestinal failure (ie, haemorrhage, intestinal perforation, acute pancreatitis)

Decline in functional status of 10% or more from admission to day 30 as measured by Barthel’s index (scores range from 0 to 100, with higher scores indicating better functional status): less decline in the intervention group

Activities of daily living score at 30 days (Barthel Index) and quality of life measured by the EQ­5D index and the EQ­5D VA, significantly better in the intervention group. 

Secondary outcomes 

Each component of the composite primary outcome (as mentioned above)

Daily protein and caloric intake

Caloric goals: 79% vs. 54%

Protein goals: 76% vs. 55% 

Mean daily caloric intake 1501 (596) vs. 1211 (517) kcal per day [517]

Protein intake 57 (23) vs. 47 g per day 

Total length of hospital stay: Not different 

5­level European Quality of Life 5 Dimensions index (EQ­5D; index values range from 0 to 1, with higher scores indicating better quality of life) including the self­assessment visual analogue scale (EQ­5D VAS; scores range from 0 to 100

Safety endpoints (side effects)

Gastrointestinal side effects

Complications due to tube feeding or central venous catheter for parenteral nutrition, 

Liver or gallbladder dysfunction, 

Hyperglycaemia, and refeeding syndrome

None of these were significantly different between groups 

A more pronounced beneficial effect of nutritional support in the population of patients with chronic kidney disease

However, the composite end point was not different between groups; 30-d survival was not a primary endpoint.


Strengths – 

  1. Pragmatic, multi-centre RCT
  2. Large sample size
  3. Complex trial but good adherence to protocol- not only demonstrated that systemic screening and intervention is feasible outside ICU, but also showed that it improved mortality- landmark trial and has definitely triggered discussions and laid the seeds for future trials.
  4. Individualised the treatment based on nutritional assessment using the H-B equation and indirect calorimetry. Also, considered disease-specific adaptations such as medium chain T, low Potassium for AKI patients.
  5. No loss to follow –up –Amazing
  6. Patient-centred outcomes were evaluated.
  7. Data sharing – consented. 

Limitations – 

  1. Masking of participants and personnel was deemed to be impractical.
  2. 215 (21%) of patients in the intervention group did not fully reach their caloric goals and 243 (24%) their protein goals, despite the implementation of the nutritional protocol by a trained dietician.
  3. Nutrition in the control group represented the reality of standard Swiss hospital food, which might not be unconditionally generalizable to other health-care systems.
  4. Authors did not yet investigate the costs of the intervention.
  5. Composite primary outcome
  6. Not directly applicable to ICU patients

Summary –

Implementation individualized nutritional support targeting proteins, calories and supplements improved important clinical outcomes at 30 days, including survival, compared with standard hospital food. 

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