Background:When patients with cirrhosis develop ascites,it is associated with sharply increasedmortality and healthcare utilization with decreased quality of life.Dietary salt restriction is first-line therapy for asc...Background:When patients with cirrhosis develop ascites,it is associated with sharply increasedmortality 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 saltrestricted(2 g sodium)meal-delivery program will report increased HRQOL compared to subjects receiving standard of care.展开更多
文摘Background:When patients with cirrhosis develop ascites,it is associated with sharply increasedmortality 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 saltrestricted(2 g sodium)meal-delivery program will report increased HRQOL compared to subjects receiving standard of care.
