THE COMPARATIVE EFFECTIVENESS OF 7 VERSUS 21 HOME-DELIVERED MEDICALLY TAILORED MEALS TO IMPROVE MALNUTRITION RISK IN MALNOURISHED PATIENTS WITH HEART FAILURE: A RANDOM ORDER CROSSOVER FEEDING TRIAL (MEDIMEALS)

1.1 Background and Relevant Literature Heart failure (HF) is a common clinical syndrome occurring in 6.2 million adults in the US with a cost of $30.7 million in 2012 due to health care services, medications, and missed days of work. The symptoms of HF result from the impaired ability of the heart to deliver blood and oxygen adequately to peripheral tissues.

Patients with HF at the Hospital of the University of Pennsylvania experience worse than expected clinical outcomes. Length of hospital stay in FY2021 (mean LOS 7.49 d, expected LOS 6.6 d) and FY22 (mean 7.21 d, expected 6.6 d), and 30-day readmissions were 17.1% in FY21 and 17.3% in FY22.

Malnutrition is a common comorbid condition with HF. In an observation of 4000 patients with HF, 57% had at least mild malnutrition, a condition that was associated with increased mortality. The malnutrition reported with HF comprises protein-energy malnutrition, muscle wasting, and cachexia, variables evaluated during malnutrition assessment.

Patients with malnutrition have worse clinical outcomes. Patients at our hospital who had moderate or severe disease-related malnutrition during the hospital stay had significantly more 30-day readmissions (40% versus 23%, OR 2.13, 1.82-2.48), greater mortality (OR 1.47, 1.0-1.99), and longer length of stay (15 vs 12 days, p= 0.0067) than patients who did not meet criteria for malnutrition4. In data from the 2012-2014 Nationwide Inpatient Sample, malnutrition was associated with mortality OR of 2.48, 2.3-2.66, almost double the admission cost, and longer length of stay of 8.7 days, 8.5-8.6 vs 5.3, 5.2-5.35.

The mainstay of HF disease management is patient self-management of medications, diet (restriction of Na with limited alcohol and fluid restriction to 1.5-2 L daily). Daily self-weighing is a strategy to detect fluid accumulation and permit adjustment of fluid intake or medical therapy. In addition to a Na restriction, the Diet Approach to Stop Hypertension or Mediterranean diet has been suggested. To optimize cardiovascular health and reduce cardiac deaths and strokes by 20%, the 2020 American Heart Association (AHA) guidelines included an evidence-based dietary approach targeting servings of six food groups (optimal intake of whole grains, fruits/vegetables, nuts/seeds/legumes, and fish; with limited intake of processed meats and sweet beverages)8 and with restriction of sodium intake to < 1500 mg and saturated fat to <7% of kcal. The DASH diet approach emphasizes intake of fruits, vegetables, whole grains, dairy, nuts/seeds/legumes, and limits intake of meat, sweets, and fats. A six-month nutrition intervention that included oral nutrition supplements in malnourished patients with HF significantly reduced mortality.