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Enrolling by invitation NCT07251894

Pilot Study Exploring the Feasibility, Acceptability, and Impact of Medically Tailored Meals on Post-Discharge Recovery in Patients With Heart Failure

No phase Interventional Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medically Tailored Meals.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

HF-MTM Pilot: Pilot Study Exploring the Feasibility, Acceptability, and Impact of Medically Tailored Meals on Post-Discharge Recovery in Patients With Heart Failure

Overview

The goal of this interventional pilot study is to evaluate the feasibility, acceptability, and impact of medically tailored meals (MTM) on post-discharge recovery in patients with heart failure for Penn Medicine patients in Philadelphia and Lancaster through two pilots.

Detailed description

Pilot 1: Will enroll 30 eligible Penn Medicine patients to receive 4 weeks of medically tailored meals (MTMs) directly to their door. Patients will be given the opportunity to choose to receive 7/14/21 meals from the MTM provider for the duration of their participation in the 4 week pilot.

Pilot 1 participants will be asked to complete a baseline survey, and end of study survey, and an end of study semi-structured interview.

Pilot 2: Will expand upon the learnings from Pilot 1 and be a larger scale longer Food is Medicine (FIM) intervention with patients receiving 8 weeks of MTM deliveries directly to their door. As with Pilot 1, patients will be given the opportunity to choose to receive 7/14/21 meals from the MTM provider for the duration of their participation in the 8 week pilot.

Pilot 2 participants will be asked to complete a baseline survey, a mid-point survey at 4 weeks, and an end of study survey and semi-structured interview.

Interventions

  • Other Medically Tailored Meals
    Medically tailored meals to provide essential tailored nutrition for patients recovering from a heart failure hospitalization

Primary outcome measures

  • Feasibility of the MTM intervention [Time frame: From enrollment to the end of the intervention at 4 weeks for Pilot 1]
  • Acceptability of the MTM intervention as measured by the Net Promoter Score [Time frame: At the end of the intervention at 4 weeks for Pilot 1.]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years old
  • Have a primary diagnosis of health failure based on ICD code I50\* with active hospitalization at time of enrollment
  • Must be insured by Medicaid or Medicare or dual eligible
  • Ability to read and speak English
  • Ability to provide informed consent

Exclusion criteria

  • Are on hospice care or reside in an acute or skilled nursing facility
  • Are undergoing evaluation for advanced HF treatments including heart transplant or ventricular assist devices
  • Are unable to complete data collection due to cognitive decline or disability (based on the electronic health record or referring provider assessment)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Penn Medicine — Philadelphia

Identifiers

NCT: NCT07251894 · 859165

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗