The purpose of this multi-center clinical trial is to study the efficacy and safety of providing nutritional support added to the study-defined standard of care which consists of standardized dietary education and a single dietary counseling session shortly after discharge, versus study-defined standard of care alone.
Veterans enrolled in a VHA facility
Hospitalized (24 hours) with new heart failure (HF) or worsening chronic HF
Dentition, swallowing function, etc. sufficient to safely consume food and liquid of standard composition and texture (i.e., no pureed food, no thickened liquids needed)
Able and willing to provide informed consent and perform study activities
Food allergies or intolerances that cannot be accommodated by study diet
On dialysis or estimated glomerular filtration rate <30 at randomization
Serum potassium (non-hemolyzed) >6.0 mmol/L during index hospitalization
Heart transplant or active transplant listing
Parallel
Home-delivered meals and short-term dietary counseling
Other interventionHome-delivered, low-sodium, nutritionally robust meals for 6 weeks plus three additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care.
Study -defined standard of care
Other interventionStudy-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge
Number of pairwise comparisons with wins of Clinical Benefit, evaluated a hierarchical composite of days alive out of hospital and =5-point difference in the change of health-related quality of life
All patients randomized to intervention are compared to all patients randomized to placebo within strata. In each comparison with any two patients, a patient will win by achieving a superior clinical outcome which is determined by sequentially assessing the following criteria with evaluation halted when distinct advantage for either patient is shown: 1. Days alive out of hospital at 6 weeks: shorter days is worse; tied, if same days alive out of hospital. Move to evaluation of 2 if tied. 2. Change of The Kansas City Cardiomyopathy Questionnaire Clinical Summary (KCCQ-CS) at 6 weeks from baseline: the threshold for the difference is greater or equal to 5 for a win; tied, if difference is less than 5. The KCCQ-CS ranges from 0 to 100, where a higher score reflects a better outcome.
DAOH at 6 months post-discharge
This outcome was selected to determine whether home-delivered meals, augmented by enhanced dietary counseling, during a high-risk period have durable effects on readmission burden.
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