Work

Design and rationale of a randomized–controlled trial of home-delivered meals for the management of symptomatic ascites: the SALTYFOOD trial

Year: 2019

Type: article

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.

Source: Gastroenterology report

DOI: 10.1093/gastro/goz005

Authors: Elliot B Tapper, Jad Baki, Scott Hummel, Anna Lok

Institutions: University of Michigan, Michigan Medicine

Language: English

Topic: Liver Disease and Transplantation

Subfield: Hepatology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $1,800