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

Meals MATTER: A Randomized Controlled 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.

Study Overview

• Status: Completed
• Conditions: Liver Failure; Heart Failure; Diabetes Mellitus; Cancer; End Stage Renal Disease; Copd
• Intervention / Treatment: Other: Medically Tailored Meals

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 650
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • St Joseph's Hospital
    • Lafayette, Colorado, United States, 80026
      • Good Samaritan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Meals - 2 weeks; Receive meal delivery for 2 weeks (1 meal per day for a total of 14 days). The medically tailored meal ordered for each participant will depend on their medical conditions.	Other: Medically Tailored Meals; Compare 2 and 4 weeks of meal delivery
Active Comparator: Meals - 4 weeks; Receive meal delivery for 4 weeks (1 meal per day for a total of 28 days). The medically tailored meal ordered for each participant will depend on their medical conditions.	Other: Medically Tailored Meals; Compare 2 and 4 weeks of meal delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety and Depression measured through the Hospital Anxiety and Depression Scale	Measured through the Hospital Anxiety and Depression Scale. 0 = Minimum. 21 = Maximum. Higher score is worse outcome.	A change in score from baseline to 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Status measured through the Katz Activities of Daily Living Scale	Measured through the Katz Activities of Daily Living. Minimum = 0, Maximum = 6. Higher score is better outcome.	A change in score from baseline to 60 days
Re-hospitalization and Emergency Department Visits	Measured through time of discharge through re-hospitalization or Emergency Department visit	60 days from hospital discharge

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Rebecca S Boxer, MD, MS, KP Institute for Health Research; Study Director: John Steiner, MD, MPH, KP Institute for Health Research

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2020
• Primary Completion (Actual): September 8, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: medically tailored meals; chronic conditions; food service
• Additional Relevant MeSH Terms: Digestive System Diseases; Hepatic Insufficiency; Kidney Diseases; Urologic Diseases; Liver Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Liver Failure; Kidney Failure, Chronic
• Other Study ID Numbers: IRB-1556587

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No