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

Tapper, Elliot B.; Baki, Jad; Hummel, Scott L.; Lok, Anna S.

doi:10.1093/gastro/goz005

Cited by 5 publications

(4 citation statements)

References 16 publications

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“…For example, Tapper and colleagues are conducting a randomized clinical trial of a home-delivered, low-sodium, high-protein meal intervention for patients with cirrhosis and ascites versus education on salt restriction, the current standard of care. 53 Community outreach programs that target social barriers can also include alternative models for care delivery. At the University of California, San Francisco, Price and colleagues designed a mobile HCV screening and treatment van, called "DeLIVER Care", which provides point-of-care HCV testing, confirmatory HCV RNA testing, mobile Fibroscan®, and on-site HCV treatment that has successfully expanded HCV care to marginalized populations in San Francisco.…”

Section: Accepted Articlementioning

confidence: 99%

Addressing Social Determinants of Liver Disease During the COVID‐19 Pandemic and Beyond: A Call to Action

et al. 2021

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The coronavirus disease 2019 (COVID-19) pandemic has exposed health care inequities in the United States and highlighted the importance of social conditions in shaping the health of individuals. In the field of hepatology, social determinants of health (SDOH) are closely linked to disparities in liver disease prevalence, outcomes, and access to treatment. The economic disruption and physical distancing policies brought on by the COVID-19 pandemic have further exacerbated these disparities, and may have long-lasting health consequences for marginalized patients with chronic liver disease. There are several ways that hepatology providers can bridge the gap in health equity through addressing SDOH, extending from the individual to the community and societal levels. Interventions at the individual level include implementation of systematic screening for social barriers in our hepatology practices to identify gaps in the care cascade. At the community and societal levels, interventions include creating collaborative partnerships with public health workers to expand health care access to the community, increasing funding for research investigating the association of SDOH, health disparities, and liver disease, engaging in advocacy to support policy reform that tackles the upstream social determinants, and addressing racism and implicit bias. As hepatology practices adapt to the "new normal," now is the time for us to address our patients' social needs within the context of health care delivery and reimagine ways in which to provide care to best serve our most vulnerable patients with liver disease in the COVID-19 era and beyond.

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Section: Accepted Articlementioning

confidence: 99%

Addressing Social Determinants of Liver Disease During the COVID‐19 Pandemic and Beyond: A Call to Action

et al. 2021

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“…All patients were randomized 1:1 to receive standard of care (SOC, an educational handout on low-sodium diets) or MTM with <2,000 mg of sodium, >2,100 kcal, and > 80 g of protein, including a nocturnal protein supplement in addition to SOC (trial registration NCT03493204) [ 9 ]. The food intervention took place from weeks 0–4 and consisted of three meals each day selected by the patient from a menu and delivered to their home on a weekly basis.…”

Section: Methodsmentioning

confidence: 99%

Medically tailored meals for the management of symptomatic ascites: the SALTYFOOD pilot randomized clinical trial

Tapper

Baki

Nikirk

et al. 2020

Gastroenterology Report

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Background Ascites is a costly, morbid complication of cirrhosis. Although a low-sodium diet is central to the clinical management of ascites, its efficacy is limited by poor adherence. We aimed to determine the feasibility and impact of low-sodium medically tailored meals (MTM) intervention. Methods We enrolled 40 persons with cirrhosis and ascites at the time of a paracentesis in a 12-week, 1:1 randomized trial of standard of care (SOC) (low-sodium diet educational handout) or MTM with <2,000 mg of sodium, >2,100 kcal, and >80 g of protein including a nocturnal protein supplement. We determined the proportion of eligible candidates recruited and adherence to MTM. The primary outcome was the number of paracenteses performed during weeks 0–12. We also collected ascites-specific quality-of-life (ASI-7) scores. Results The median age of the enrolled subjects was 54 (IQR, 47–63) years, 46% were female, with median MELD-Na 18 (IQR, 11–23) and albumin 2.7 (IQR, 2.5–3.3) g/dL. At baseline, subjects reported a median of two (IQR, 1–3) paracenteses in the prior 4 weeks. Adherence to the meal schedule was excellent save for when hospitalizations occurred. After 12 weeks, patients in the MTM arm required fewer paracenteses per week than those in the SOC group [median (IQR): 0.34 (0.14–0.54) vs 0.45 (0.25–0.64)]. During the trial, four (20%) SOC patients died, whereas two (10%) died and one (5%) was transplanted in the MTM arm. Ascites-specific quality of life improved to a greater degree in the MTM arm compared to the SOC arm, by 25% (IQR, –11% to 61%) vs 13% (IQR, –28% to 54%). Conclusion A trial of MTM for persons with ascites is feasible and potentially effective. Both arms experienced benefits, highlighting the role for improved education and closer monitoring in this challenging condition.

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“…For decades, body weight has been identified as a useful proxy for ascites volume, but accurate weight monitoring at home has been difficult. In fact, monitoring weight is central to expert guidelines for ascites management [ 8 , 9 ] and treatment trials [ 10 - 12 ]. Weight changes signal a change in ascites volume and may provoke laboratory testing for renal injury, modification of diuretic dose, and large-volume paracentesis (LVP).…”

Section: Introductionmentioning

confidence: 99%

A Smartphone App to Manage Cirrhotic Ascites Among Outpatients: Feasibility Study

Bloom¹,

Wang²,

Marx³

et al. 2020

JMIR Med Inform

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Background Ascites is a common, painful, and serious complication of cirrhosis. Body weight is a reliable proxy for ascites volume; therefore, daily weight monitoring is recommended to optimize ascites management. Objective This study aims to evaluate the feasibility of a smartphone app in facilitating outpatient ascites management. Methods In this feasibility study, patients with cirrhotic ascites requiring active management were identified in both inpatient and outpatient settings. Patients were provided with a Bluetooth-connected scale, which transmitted weight data to a smartphone app and then via the internet to an electronic medical record (EMR). Weights were monitored every weekday. In the event of a weight change of ≥5 lbs in 1 week, patients were called and administered a short symptom questionnaire, and providers received an email alert. The primary outcomes of this study were the percentage of enrolled days during which weight data were successfully transmitted to an EMR and the percentage of weight alerts that prompted responses by the provider. Results In this study, 25 patients were enrolled: 12 (48%) were male, and the mean age was 58 (SD 13; range 35-81) years. A total of 18 (72%) inpatients were enrolled. Weight data were successfully transmitted to an EMR during 71.2% (697/979) of the study enrollment days, with technology issues reported on 16.5% (162/979) of the days. Of a total of 79 weight change alerts fired, 41 (52%) were triggered by weight loss and 38 (48%) were by weight gain. Providers responded in some fashion to 66 (84%) of the weight alerts and intervened in response to 45 (57%) of the alerts, for example, by contacting the patient, scheduling clinic or paracentesis appointments, modifying the diuretic dose, or requesting a laboratory workup. Providers responded equally to weight increase and decrease alerts (P=.87). The staff called patients a mean of 3.7 (SD 3.5) times per patient, and the number of phone calls correlated with technology issues (r=0.60; P=.002). A total of 60% (15/25) of the patients chose to extend their participation beyond 30 days. A total of 17 patient readmissions occurred during the study period, with only 4 (24%) related to ascites. Conclusions We demonstrated the feasibility of a smartphone app to facilitate the management of ascites and reported excellent rates of patient and provider engagement. This innovation could enable early therapeutic intervention, thereby decreasing the burden of morbidity and mortality among patients with cirrhosis.

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

Cited by 5 publications

References 16 publications

Addressing Social Determinants of Liver Disease During the COVID‐19 Pandemic and Beyond: A Call to Action

Addressing Social Determinants of Liver Disease During the COVID‐19 Pandemic and Beyond: A Call to Action

Medically tailored meals for the management of symptomatic ascites: the SALTYFOOD pilot randomized clinical trial

A Smartphone App to Manage Cirrhotic Ascites Among Outpatients: Feasibility Study

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