A Trial to Evaluate Medically Tailored Meals With Patients With Heart Failure

NCT ID: NCT04289181

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-05
• Study Completion Date: 2021-04-01

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Medically Tailored Meals (MTM)

Participants randomized to the MTM arm will receive MTM for 4 weeks. Meals will be prepared and delivered by Meals on Wheels, a non-profit organization that has been delivering meals to seniors nationwide for decades. Meals on Wheels will deliver 21 complete meals to the patient's home each week. They can accommodate a wide range of patient needs and preferences (e.g., low sodium, gluten-free, no pork products, cultural preferences). Meals on Wheels will contact the patient directly to set up an initial assessment phone call to collect relevant data (e.g., specific patient goals for their HF) and to set up a delivery schedule. Nearing the 4-week mark when meal delivery ends, investigators will check-in with each participant to track progress, assess treatment fidelity and answer any questions. All patients will receive information on community resources (e.g., food pantries, food banks) in the area.

Group Type: EXPERIMENTAL

Medically Tailored Meals

Intervention Type: OTHER

4 weeks of medically tailored meals

Usual Care

Patients in this arm will receive usual services offered at Jefferson for patients with HF. This includes regular visits with a HF provider (primary care or cardiology), standard nutrition teaching, medication optimization and post discharge support. During routine office visits, providers reinforce messages about self-management and provide lists of local and national resources related to nutrition and HF self-management. These services follow guideline directed medical therapy. All patients will receive information on community resources (e.g., food pantries, food banks) in the area.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Medically Tailored Meals

4 weeks of medically tailored meals

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

AnnaMarie Chang

Associate Professor, Director of Clinical Research Operations

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

19G.837

Identifier Type: -

Identifier Source: org_study_id