Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06115369 |
| Other study ID # |
STU-2023-0978 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2024 |
| Est. completion date |
May 1, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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?
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.
