INNOVATION FUND Technology and AI in Healthcare Quality and Safety SHOWCASE 2019

Randomized Control Trial of Nutritional Care Pathway in Malnourished Hospitalized Medical Patients: Pilot Study

Quality and Safety

Highlights

AMO-15-007 Malnutrition is a debilitating and highly prevalent condition in the acute hospital setting.  We conducted a factorial-design 2×2 randomized trial of a novel nutritional pathway where we identified at-risk hospitalized medical patients, and then provided nutritional supplementation in hospital and after discharge for 28 days, with 5 days of intravenous nutrition delivered through a peripheral vein vs. no intravenous nutrition, as well as daily oral nutritional supplementation vs. no supplementation.  The ONS intervention demonstrated a strong trend towards lowering the risk of the composite outcome, mainly by reducing the risk of readmission (relative risk reduction 0.49, 95% confidence interval 0.23-1.01). This demonstrates the possibility that our intervention may have true and clinically relevant beneficial effect, with a magnitude that would revolutionize in-patient medical care.

Abstract

AMO-15-007 BACKGROUND:  Malnutrition is a debilitating and highly prevalent condition in the acute hospital setting. It contributes to depression of the immune system, impaired wound healing, muscle wasting, longer lengths of hospital stay, higher readmission rates, higher treatment costs and marked increases in mortality. Despite the devastating consequences of malnutrition, health care practitioners are poor in respect to the identification, monitoring and treatment of hospital malnutrition.  OBJECTIVES AND METHODS:  We conducted a factorial-design 2×2 randomized pilot trial to determine the feasibility and safety of a novel nutritional pathway. We identified at-risk hospitalized medical patients, and then provided nutritional supplementation in hospital and after discharge for 28 days, with 5 days of intravenous nutrition delivered through a peripheral vein (PPN) vs. no intravenous nutrition, as well as daily oral nutritional supplementation (ONS) vs. no supplementation. 2  RESULTS: We recruited 100 patients from two sites over an 18-month period. There were no adverse events related to the study intervention. The incidence of the overall composite outcome of death, continued admission or hospital readmission was 28% (28/100), with a mortality incidence of 6%. There was no statistically significant change in clinical outcomes with the PPN intervention. The ONS intervention demonstrated a trend towards lowering the risk of the composite outcome, mainly by reducing the risk of readmission (RR 0.49, 95% confidence interval 0.23-1.01).  CONCLUSION: This pilot study demonstrates the need for urgent and meaningful interventions to reduce morbidity and mortality in this population, and illustrates that both peripheral parenteral nutrition as well as oral nutrition supplementation are safe in the study population.

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