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Abstract
Background
When patients with cirrhosis develop ascites, it is associated with sharply increased mortality and healthcare utilization with decreased quality of life. Dietary salt restriction is first-line therapy for ascites but it is limited by poor adherence.
Methods
We will recruit 40 patients with cirrhosis and ascites who have received a recent paracentesis or hospitalization for a 1:1 randomized trial of standard care (education on salt restriction) versus home-delivered meals. Our primary outcome is the number of paracenteses needed over 12 weeks. Secondary outcomes include hospital-bed days, health-related quality of life (HRQOL, Ascites Symptom Inventory-7 and Visual Analogue Scale) and performance on batteries of physical function including hand grip (kg) and walk speed (m/s). All subjects follow up through a series of calls where any paracenteses, hospital readmissions, weight changes and diuretic dosage changes are recorded. In a final Week 12 visit, knowledge of dietary sodium intake, quality of life and frailty are reassessed, and satisfaction with the meal-delivery program is evaluated. Paired comparison testing will be conducted between the two arms.
Discussion
A nutritionally standardized meal-delivery program for patients with cirrhosis and ascites post discharge has a variety of potential patient-based benefits, including the effective management of ascites, reduction of healthcare utilization and improvement of HRQOL. We have three core hypotheses. First, patients will report interest in and satisfaction with a home-delivered meals program. Second, subjects on a salt-restricted (2 g sodium) meal-delivery program will have fewer therapeutic paracenteses and all-cause readmissions than subjects receiving standard of care. Third, subjects on a salt-restricted (2 g sodium) meal-delivery program will report increased HRQOL compared to subjects receiving standard of care.
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Details
1 Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA
2 University of Michigan, Ann Arbor, Michigan, USA
3 Division of Cardiology, Department of Internal Medicine University of Michigan, Ann Arbor, Michigan, USA