Food Supplementation Delivered Conditionally vs Not Among Patients With Heart Failure

Study Overview
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Brief Summary
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The current study proposes to investigate if the provision of healthy food can improve outcomes following discharge after HF hospitalization. To investigate this in an efficient and pragmatic manner, a 3 x2 factorial randomized control trial design will be utilized to simultaneously investigate two separate, important food-related questions: Does provision of 90 days of either medically-tailored meals or fresh produce boxes improve 90-day patient outcomes among those with HF relative to a control group not receiving food supplements and instead receiving an equivalent monetary supplement? Does receipt of the supplement in a conditional fashion, where the supplement is continued only if the participant attends follow-up visits or fills prescribed medications at the pharmacy, have more impact than providing unconditional supplementation?

Detailed Description
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Eating a nutritious diet is important for maintaining health. However, getting healthy foods can be a challenge for many individuals whose food shopping is limited by finances, location, or physical limitations from pre-existing health problems. For such in-need individuals, providing supplemental healthy meals can improve their diet and potentially improve their health outcomes. Additionally, getting food supplements can also be a powerful incentive to encourage healthy behaviors. Individuals with heart failure (HF) present a unique population to assess the value of food supplementation both for its nutritional value and as a health engagement incentive. HF is a common, high-cost public health problem in the United States. Hospitalizations for HF are associated with high rates of mortality, readmission, worsened quality of life, and burgeoning healthcare expenditures. During the post-discharge period, patients are exceptionally vulnerable to a wide variety of adverse health events due to multi-system physiologic impairments. Roughly 20% of all patients with Medicare are readmitted within 30 days, and many are readmitted for different causes than the principal diagnosis of the index admission. While multifactorial, frequent contributing causes of HF readmission include dietary indiscretion, failure to take medications, and failure to follow up with healthcare providers. Prior studies demonstrate that patients with HF often have food insecurity and non-ideal diets. Nationally, food insecurity among those patients with cardiovascular diseases has increased. Those with HF specifically had some of the highest rates of food insecurity, and the prevalence of food insecurity rose from 11.3% in 1999-2000 to 45.3% in 2017-2018. Studies have also investigated whether providing food supplements to patients with HF can potentially also improve health outcomes. In a recent cohort study, Medicare Advantage patients with acute heart failure (HF) were given up to 4 weeks of post-hospitalization home-delivered meals. Compared with historical controls, those receiving these meals were significantly less likely to have all-cause readmission and death. In contrast, a recent randomized clinical trial found that providing 10 weeks of medically tailored meals to patients with chronic diseases hospitalized during the COVID-19 pandemic did not lead to reductions in risk of 90-day readmission. However, in an exploratory sub-analysis, patients with HF who had the medically tailored meal intervention had significant reductions in readmissions. While these data are supportive of the hypothesis, they are not definitive, and a prospective randomized trial among patients with HF is needed to rigorously support the efficacy of food support in the post-discharge period to reduce readmission. There is also limited information on the type and means of food supplementation may affect its efficacy. Based on this background, the current study proposes to investigate if the provision of healthy food can improve outcomes following discharge after HF hospitalization. To investigate this in an efficient and pragmatic manner, a 3 x2 factorial randomized control trial design will be used that will simultaneously investigate two separate important food-related questions. The first factorial design question will evaluate the direct impact of two nutritional supplementation strategies on HF rehospitalizations. Specifically, those hospitalized for HF will be randomized at hospital discharge to either 90 days of healthy medically tailored full meals (MTM) (n=50) or 90 days of a weekly fresh produce box (n=50) or to a control arm (usual care receiving no food supplements) (N=50). The second factorial intervention will determine whether food supplements can be used as an incentive to increase patient engagement in their own care (i.e., attending a follow-up clinic visit and filling their prescriptions). Specifically, participants will be randomized 1:1 to receive their food supplements (MTMs or produce box) in an unconditional or conditional fashion based on the participant successfully attending their visit and filling their medication. Note: for those randomized to no food supplement in first phase, these also will be randomized to receive a small financial copay (equivalent to the value of their food supplements) in an unconditional fashion or conditionally based on attending their follow-up appointment and filling their medications.

Official Title
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Examining the Impact of Medically Tailored Meals vs Produce Supplements Delivered Conditionally vs Not on Health Engagement and Health Outcomes Among Patients With Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Dietary Supplement: Medically Tailored Meals
* Dietary Supplement: Fresh Produce
* Other: Control (financial support only)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults over 18 years age with a recent hospitalization for acute decompensated HF Exclusion Criteria: Baseline hyperkalemia with K > 5.5 mEq/L or history of hyperkalemia requiring hospitalization for urgent treatment, Receipt of a heart transplant or left ventricular assist device, Use of inotropic therapy at hospital discharge, Discharge to a skilled nursing facility or long-term care facility that provides prepared patient meals, comorbidity with expected survival < 6 months, and Inability to provide an address to receive produce shipments (including unhoused individuals or individuals residing in temporary housing shelters). Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The study will be designed as a 3 x 2 factorial randomized clinical trial. First, study patients will be randomized 1:1:1 to receive medically tailored meals (MTM) twice daily (N = 50) vs. weekly fresh produce box (N = 50) vs. a control arm (without food supplement but getting a small monetary gift card) (N=50). Note the financial value of each of the intervention arms will be approximately equivalent. In the second factorial intervention, participants will be randomized 1:1 to receive their food supplements (or gift card) in a conditional fashion, based on whether they attend a clinic visit and fill their meds (N =75) vs. receiving the intervention unconditionally (N =75). The intervention will be initiated within a week of hospital discharge and will continue for a period of 90 days.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unconditional continuation of food supplement or monetary supplement<br>Participants will receive food or monetary supplement for the duration of the study period. | Dietary Supplement: Medically Tailored Meals<br>* Season Health, our food intervention partner, will provide participants with weekly deliveries of twice daily prepared medically tailored meals (MTM). Study participants will be able to select choices for these from a large selection of health options. The study team will work with Season Health to create customizations to allow for the incorporation of patient dietary preferences. Study team members will assist patients in setting up their Season Health accounts.<br>Dietary Supplement: Fresh Produce<br>* We will work with Season Health, our food intervention partner to provide participants with weekly deliveries of a large box full of fresh produce. The study participants will be able to select choices for these from a large selection of health options. The study team will work with Season Health to create customizations to allow for the incorporation of patient dietary preferences. Study team members will assist patients in setting up their Season Health accounts.<br>Other: Control (financial support only)<br>* Those randomized to not receiving the food supplement will instead receive a gift card weekly for participating in the study and filling out the surveys, etc. The value of the weekly gift card will approximate the value of the weekly food boxes.<br>|
| Experimental: Conditional continuation of food supplement or monetary supplement<br>Participants will receive the first weeks food or monetary supplement, and continued supplements will be tied to patient attendance to doctor's visits and pharmacy refills. If patient engagement/participation lapses, supplement | Dietary Supplement: Medically Tailored Meals<br>* Season Health, our food intervention partner, will provide participants with weekly deliveries of twice daily prepared medically tailored meals (MTM). Study participants will be able to select choices for these from a large selection of health options. The study team will work with Season Health to create customizations to allow for the incorporation of patient dietary preferences. Study team members will assist patients in setting up their Season Health accounts.<br>Dietary Supplement: Fresh Produce<br>* We will work with Season Health, our food intervention partner to provide participants with weekly deliveries of a large box full of fresh produce. The study participants will be able to select choices for these from a large selection of health options. The study team will work with Season Health to create customizations to allow for the incorporation of patient dietary preferences. Study team members will assist patients in setting up their Season Health accounts.<br>Other: Control (financial support only)<br>* Those randomized to not receiving the food supplement will instead receive a gift card weekly for participating in the study and filling out the surveys, etc. The value of the weekly gift card will approximate the value of the weekly food boxes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with a readmission for heart failure or ER visit | Any readmission or visit to the emergency department (yes/no) | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants attending the first scheduled clinic appointment |  | 90 days | 
| Filling of outpatient medication prescription | Percent | 90 days | 
| Medication adherence | Morisky Medication Adherence Score. Scores are summed from 0 to 8, with higher scores meaning better adherence. | 90 days | 
| Intergroup change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary | The KCCQ summary score ranges from 0 to 100, where higher scores indicating better quality of life. | The survey will be assessed at baseline and at 90 days at the conclusion of the study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Produce, Medically Tailored Meals, Patient Participation