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Completed

NCT Number: NCT04351880

Meals MATTER: A Trial of Medically Tailored Meals 2 Weeks vs. 4 Weeks Post Hospital Discharge

The purpose of this study is to determine if medically tailored meals provided for either 2 weeks or 4 weeks (1 meal per day) to a Kaiser Permanente Colorado (KPCO) member after hospital discharge will improve their health. Medically tailored meals (MTM) are meals that are approved by a dietitian and shown to help people with certain health conditions.

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Key information

About this study

The purpose of this study is to determine if medically tailored meals provided for either 2 weeks or 4 weeks (1 meal per day) to a Kaiser Permanente Colorado (KPCO) member after hospital discharge will improve their health. Medically tailored meals (MTM) are meals that are approved by a dietitian and shown to help people with certain health conditions.

The Investigators propose a research study with four Specific Aims:

Specific Aim 1: To determine if MTM provided post hospitalization for 4 weeks to patients with one or more of seven chronic health conditions will decrease depression/anxiety measured by the Hospital Anxiety and Depression Scale (HADS) at 60 days in comparison to meals provided for 2 weeks to members discharged from two hospitals.

Hypothesis 1: Patients receiving meals for 4 weeks will have a clinically significant increase in their HADS score at 60 days compared to those receiving meals for 2 weeks.

Specific Aim 2: To determine if MTM provided for 4 weeks to patients with one or more of seven chronic health conditions post hospitalization will improve general well-being and functional status measured by Katz's Activities of Daily Living (ADL).

Hypothesis 2: Patients receiving meals for 4 weeks will have a clinically significant increase in their sense of well-being and ADLs at 60 days compared to those receiving meals for 2 weeks.

Specific Aim 3: To determine if MTM provided for 4 weeks to patients with one or more of seven chronic health conditions post hospitalization will decrease a composite outcome of rehospitalizations and emergency department (ED) visits at 60 days in comparison to: a) meals provided for 2 weeks to members discharged from two hospitals; and b) a concurrent prospective control group not receiving meals at two other KPCO-contracted hospitals.

Hypothesis 3: Patients receiving meals for 4 weeks will have a decreased composite rate of rehospitalizations and ED visits at 60 days compared to those receiving meals for 2 weeks or the non-randomized control group.

Specific Aim 4: To determine the feasibility, acceptability and scalability of the Meals Matter Program to KP members, their households, and hospital leadership and staff.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older, with no upper age limit
  • Hospitalized at Saint Joseph Hospital or Good Samaritan Medical Center with the anticipation that they will be discharged home
  • Member of a KP health plan
  • Have one or more of the following conditions:
  • Heart failure
  • Cancer
  • End-stage renal disease (ESRD)/chronic renal disease
  • Chronic obstructive pulmonary disease (COPD)
  • Diabetes Mellitus
  • Chronic liver disease/cirrhosis

Exclusion criteria

  • Patient discharged to a nursing home, an assisted living facility, or another setting where meals are institutionally provided
  • Patient has a health condition which is incompatible with the diet choices offered by Project Angel Heart (PAH - food service vendor)
  • Patient refuses the type of meal best for their medical condition
  • Patient has dementia
  • Patient is pregnant or hospitalized peri-partum
  • Patient is an active participant in a PAH program or another meal program
  • Patient is unable to speak English or Spanish
  • PAH unable to deliver meals due to patient not being in PAH service area
  • Patient was discharged from the hospital within 24 hours of admission
  • Patient whose household member has enrolled in the Meals MATTER study
  • Patient discharged to hospice care

Treatment and study plan

Medically Tailored Meals

Other

Compare 2 and 4 weeks of meal delivery

Primary outcomes

  1. Anxiety and Depression measured through the Hospital Anxiety and Depression Scale

    Time frame: A change in score from baseline to 60 days

    Measured through the Hospital Anxiety and Depression Scale. 0 = Minimum. 21 = Maximum. Higher score is worse outcome.

Secondary outcomes

  1. Functional Status measured through the Katz Activities of Daily Living Scale

    Time frame: A change in score from baseline to 60 days

    Measured through the Katz Activities of Daily Living. Minimum = 0, Maximum = 6. Higher score is better outcome.

  2. Re-hospitalization and Emergency Department Visits

    Time frame: 60 days from hospital discharge

    Measured through time of discharge through re-hospitalization or Emergency Department visit

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

Meals MATTER: A Randomized Controlled Trial of Medically Tailored Meals 2 Weeks vs. 4 Weeks Post Hospital Discharge

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 17, 2020
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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