CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)

Study Overview
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Brief Summary
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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.

Official Title
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CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Home-delivered meals and short-term dietary counseling
* Other: Study -defined standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 60 years Veterans enrolled in a VHA facility Hospitalized ( 24 hours) with new 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 Exclusion Criteria: 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 Left ventricular assist device present or anticipated <6 months Malignancy or other non-cardiac condition limiting life expectancy to <12 months Planned admission to a skilled nursing facility following hospital discharge, or discharge to other location/situation where Veteran does not have control over diet Lack of space to store food for a week or equipment to prepare food Severe cognitive impairment (SLUMS score <20, or <19 if less than high school education completed) Severe food insecurity (5 or 6 points on the USDA 6-item Food Insecurity Screen) Body mass index >50 kg/m2 Other medical, psychiatric, behavioral, or logistical condition which, in the clinical judgement of the site investigator, makes it unlikely the patient can effectively participate in or complete the study

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm study: active intervention vs study-defined standard of care
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Study-defined standard of care | Other: Study -defined standard of care<br>* study-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge<br>|
| Experimental: Home-delivered meals and short-term dietary counseling<br>Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus two additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care. | Other: Home-delivered meals and short-term dietary counseling<br>* Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus two additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: 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. 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. | within 6 weeks post-index hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months post-discharge |