Clinical trial NCT06115369: Food Supplementation Delivered Conditionally vs Not Among Patients With Heart Failure
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Produce
Medically Tailored Meals
Patient Participation
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2023-11-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The study will be designed as a 2 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 (dietary counseling only) (N=50). In the second factorial intervention, participants will be randomized 1:1 to receive their food supplements in a conditional fashion, based on whether they attend a clinic visit and fill their meds (N =50) vs. receiving the intervention unconditionally (N =50). The intervention will be initiated within a week of hospital discharge and will continue for a period of 90 days.
Primary purpose: TREATMENT

Brief summary: 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 2x2 factorial randomized control trial design will be utilized to simultaneously investigate two separate, important food-related questions:

* Does the 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: 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 2 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 receiving food supplementation 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with a readmission for heart failure or ER visit
timeFrame: 90 days
Secondary outcomes:
measure: Number of participants attending the first scheduled clinic appointment
timeFrame: 90 days
measure: Filling of outpatient medication prescription
timeFrame: 90 days
measure: Medication adherence
timeFrame: 90 days
measure: Intergroup change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary
timeFrame: The survey will be assessed at baseline and at 90 days at the conclusion of the study.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern
name: Ambarish Pandey
role: PRINCIPAL_INVESTIGATOR
References: