Clinical trial NCT04289181: A Trial to Evaluate Medically Tailored Meals With Patients With Heart Failure
Official title: A Pilot Trial Assessing the Feasibility of Providing Medically-tailored Meals to Patients Diagnosed With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enrolled patients will be randomized to 1 of 2 arms: 1) MTM; or 2) usual care in a 1:1 ratio. A computer-generated list of random numbers will be prepared in advance by the study biostatistician and loaded into a REDCap randomization tool to ensure the research staff are blinded to assignment pre-randomization.
Primary purpose: OTHER

Brief summary: The goal is to conduct a pilot trial that provides 4 weeks of medically-tailored meals (MTM) to patients with heart failure (HF) via collaboration with the Philadelphia Meals on Wheels chapter to assess the feasibility of such an intervention. Patients will be enrolled during either an inpatient hospitalization or an emergency department (ED) visit, and will be randomized into 1 of 2 arms: 1) MTM or 2) usual care that follows guideline-directed medical therapy (GDMT). Evidence gathered from this study will guide the design of a larger randomized controlled trial to be submitted to the National Institutes of Health (NIH) to evaluate the scalability, sustainability and cost-effectiveness of MTM for improving outcomes for patients with HF.

Detailed description: While medication adherence and transitions from hospitalization to home care play important roles in heart failure (HF) care, the majority of HF maintenance is by the patients in the home. Despite the availability of evidence-based guidance and treatments, many patients with HF do not achieve optimal outcomes. In prior work, patients with HF identified primary needs of improved access to food and nutrition education. Dietary recommendations for HF in clinical practice have historically emphasized the reduction of a single micronutrient (sodium) and fluid management, which oversimplifies the complexity between multiple dietary inadequacies, including micronutrient deficiencies, and HF pathophysiology. In addition, patients may have other comorbidities thus requiring further modification of the patient's diet. As a result, several innovative models for food services have emerged to address patient needs for improved healthy food access. Currently, select non-profit organizations across the U.S. deliver millions of medically-tailored meals (MTM) to patients with chronic illnesses, based on the premise that food can be as helpful as medicine in improving patient outcomes. Small studies assessing MTM in isolation have demonstrated reduced healthcare utilization and cost, however, no randomized trials have assessed the sustained impact of this intervention. The goal is to evaluate the feasibility of providing medically-tailored meals to patients with HF. Data from this study can be used to design further studies testing the effectiveness of MTM on improving outcomes for patients with HF.

Meals on Wheels, a provider of meals to senior citizens across the country, has only recently begun piloting medically-tailored meals, and this presents the opportunity to work with the organization to test the feasibility of MTM in the Philadelphia region.

Eligibility criteria: Inclusion Criteria:

1. Have a diagnosis of acute heart failure (AHF), as determined by the treating physician
2. Are 50 years of age or older
3. Are a patient in the ED or inpatient at TJUH or Methodist Hospita
4. Are able to keep food fresh for a week after delivery (e.g., not homeless)
5. Have an address that is within the delivery radius of Meals on Wheels-Philadelphia
6. Be able and willing to be available for follow-up contact

Exclusion Criteria:

1. Pregnant, planning to be pregnant, or currently breastfeeding.
2. Does not eat by mouth (i.e. receives tube feeds or total parenteral nutrition \[TPN\])
3. Psychiatric co-morbidity that would preclude study participation
4. Non-English speaking
5. In police custody or incarcerated
6. Currently receiving MTM from Meals on Wheels or another provider

Primary outcomes:
measure: Feasibility: Enrollment
timeFrame: One year
measure: Feasibility: Retention
timeFrame: 4 weeks
measure: Feasibility: Retention
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient satisfaction with intervention
timeFrame: 4 weeks
measure: Feasibility of administering the patient activation measure short form (PAM-13)
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Feasibility of administering the Dutch Heart Failure Knowledge Scale
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Feasibility of administering the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12)
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Feasibility of administering the Minnesota Living with Heart Failure Questionnaire (MLHF)
timeFrame: Baseline, 4 weeks, 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References: