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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.

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.

SUBMITTER: Tapper EB

PROVIDER: S-EPMC6454849 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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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.

Tapper Elliot B EB Baki Jad J Hummel Scott S Lok Anna A

Gastroenterology report 20190311 2

<h4>Background</h4>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.<h4>Methods</h4>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 mea ...[more]

PMID: 30976428

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Project description:Background In patients with heart failure (HF), malnutrition and dietary sodium excess are common and may worsen outcomes. No prior studies have provided low-sodium, nutritionally complete meals following HF hospitalization. Methods and Results The GOURMET-HF study (Geriatric Out-of-Hospital Randomized Meal Trial in Heart Failure) randomized patients discharged from HF hospitalization to 4 weeks of home-delivered sodium-restricted Dietary Approaches to Stop Hypertension meals (DASH/SRD; 1500 mg sodium/d) versus usual care. The primary outcome was the between-group change in the Kansas City Cardiomyopathy Questionnaire summary score from discharge to 4 weeks postdischarge. Additional outcomes included changes in the Kansas City Cardiomyopathy Questionnaire clinical summary score and cardiac biomarkers. All patients were followed 12 weeks for death/all-cause readmission and potential diet-related adverse events (symptomatic hypotension, hyperkalemia, acute kidney injury). Sixty-six patients were randomized 1:1 at discharge to DASH/SRD versus usual care (age, 71±8 years; 30% female; ejection fraction, 39±18%). The Kansas City Cardiomyopathy Questionnaire summary score increased similarly between groups (DASH/SRD 46±23-59±20 versus usual care 43±19-53±24; P=0.38), but the Kansas City Cardiomyopathy Questionnaire clinical summary score increase tended to be greater in DASH/SRD participants (47±22-65±19 versus 45±20-55±26; P=0.053). Potentially diet-related adverse events were uncommon; 30-day HF readmissions (11% versus 27%; P=0.06) and days rehospitalized within that timeframe (17 versus 55; P=0.055) trended lower in DASH/SRD participants. Conclusions Home-delivered DASH/SRD after HF hospitalization appeared safe in selected patients and had directionally favorable effects on HF clinical status and 30-day readmissions. Larger studies are warranted to clarify the effects of postdischarge nutritional support in patients with HF. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02148679.

Project description:ImportanceHome-delivered meals promote food security and independence among homebound older adults. However, it is unclear which of the 2 predominant modes of meal delivery, daily-delivered vs mailed (or drop-shipped) frozen meals, promotes community living for homebound older adults with dementia.ObjectiveTo assess the risk of nursing home admission within 6 months between homebound individuals receiving daily-delivered vs drop-shipped frozen meals.Design, setting, and participantsThis pilot, multisite, 2-arm, pragmatic clinical trial included older adults with self-reported dementia on waiting lists for meals at 3 Meals on Wheels (MOW) programs in Texas and Florida between April 7 and October 8, 2021, to assess time to nursing home placement.InterventionsParticipants were randomized to receive either meals delivered by an MOW driver or frozen meals that were mailed to participants' homes every 2 weeks. Participants received their assigned intervention for up to 6 months.Main outcomes and measuresThe primary study outcome was days from randomization to a Minimum Data Set nursing home admission assessment within 6 months. Feasibility of conducting this type of study was examined by tracking enrollment, examining baseline characteristics, monitoring participants' intervention fidelity, measuring the proportion of participants linked with Centers for Medicare & Medicaid Services (CMS) data, and analyzing the primary study outcome.ResultsAmong 325 eligible participants who were randomized, 243 enrolled in the study (mean [SD] age, 81 [8.0] years; 152 (62.6%) were female): 128 to the daily-delivered meals group and 115 to the drop-shipped frozen meals group; 119 participants (49.0%) lived alone. Among the total participants enrolled, 227 (93.4%) were linked deterministically to their CMS data; probabilistic methods were used to link the remaining 16 participants (6.6%). At 6 months from randomization, 160 participants (65.8%) were still receiving meals, and 25 (10.1%; 95% CI, 6.3%-14.0%) were admitted to a nursing home. After adjusting for sex, race and ethnicity, age, program, and living arrangement and the use of death as a censoring event, the adjusted log hazard ratio of nursing home placement between daily-delivered and drop-shipped frozen meals was -0.67 (95% CI, -1.52 to 0.19).Conclusions and relevanceThis pilot randomized clinical trial demonstrated the feasibility of enrolling participants with self-reported dementia on waiting lists at MOW programs, linking their data, and evaluating outcomes. While this pilot study was not powered to detect meaningful, statistically significant differences in nursing home placement, its feasibility and initial results warrant exploration in a follow-on, adequately powered trial.Trial registrationClinicalTrials.gov Identifier: NCT04850781.

Project description:Most methadone-maintained injection drug users (IDUs) have been infected with hepatitis C virus (HCV), but few initiate HCV treatment. Physicians may be reluctant to treat HCV in IDUs because of concerns about treatment adherence, psychiatric comorbidity, or ongoing drug use. Optimal HCV management approaches for IDUs remain unknown. We are conducting a randomized controlled trial in a network of nine methadone clinics with onsite HCV care to determine whether modified directly observed therapy (mDOT), compared to treatment as usual (TAU), improves adherence and virologic outcomes among opioid users.We plan to enroll 80 HCV-infected adults initiating care with pegylated interferon alfa-2a (IFN) plus ribavirin, and randomize them to mDOT (directly observed daily ribavirin plus provider-administered weekly IFN) or TAU (self-administered ribavirin plus provider-administered weekly IFN). Our outcome measures are: 1) self-reported and pill count adherence, and 2) end of treatment response (ETR) or sustained viral response (SVR). We will use mixed effects linear models to assess differences in pill count adherence between treatment arms (mDOT v. TAU), and we will assess differences between treatment arms in the proportion of subjects with ETR or SVR with chi square tests. Of the first 40 subjects enrolled: 21 have been randomized to mDOT and 19 to TAU. To date, the sample is 77% Latino, 60% HCV genotype-1, 38% active drug users, and 27% HIV-infected. Our overall retention rate at 24 weeks is 92%, 93% in the mDOT arm and 92% in the TAU arm.This paper describes the design and rationale of a randomized clinical trial comparing modified directly observed HCV therapy delivered in a methadone program to on-site treatment as usual. Our trial will allow rigorous evaluation of the efficacy of directly observed HCV therapy (both pegylated interferon and ribavirin) for improving adherence and clinical outcomes. This detailed description of trial methodology can serve as a template for the development of future DOT programs, and can also guide protocols for studies among HCV-infected drug users receiving methadone for opiate dependence.

Project description:The high-risk strategy has been proven effective in preventing cardiovascular disease; however, the population benefits from these interventions remain unknown. This study aims to assess, at the population level, the effects of an evidence-based high cardiovascular risk management program delivered by village doctors in rural China.The study will employ a cluster-randomized controlled trial in which a total of 120 villages in five northern provinces of China, will be assigned to either intervention (60 villages) or control (60 villages). Village doctors in intervention villages will be trained to implement a simple evidence-based management program designed to identify, treat and follow-up as many as possible individuals at high-risk of cardiovascular disease in the village. The intervention will also include performance feedback as well as a performance-based incentive payment scheme and will last for 2 years. We will draw two different (independent) random samples, before and after the intervention, 20 men aged?50 years and 20 women aged?60 years from each village in each sample and a total of 9,600 participants from 2 samples to measure the study outcomes at the population level. The primary outcome will be the pre-post difference in mean systolic blood pressure, analyzed with a generalized estimating equations extension of linear regression model to account for cluster effect. Secondary outcomes will include monthly clinic visits, provision of lifestyle advice, use of antihypertensive medications and use of aspirin. Process and economic evaluations will also be conducted.This trial will be the first implementation trial in the world to evaluate the population impact of the high-risk strategy in prevention and control of cardiovascular disease. The results are expected to provide important information (effectiveness, cost-effectiveness, feasibility and acceptability) to guide policy making for rural China as well as other resource-limited countries.The trial is registered at ClinicalTrials.gov (NCT01259700). Date of initial registration is December 13, 2010.

Dataset Information

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

Publications

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

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