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

Primary Purpose

Heart Failure, Copd, Liver Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medically Tailored Meals
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring medically tailored meals, chronic conditions, food service

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Joseph's Hospital
  • Good Samaritan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Meals - 2 weeks

Meals - 4 weeks

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Re-hospitalization and Emergency Department Visits
Measured through time of discharge through re-hospitalization or Emergency Department visit

Full Information

First Posted
April 14, 2020
Last Updated
February 16, 2022
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT04351880
Brief Title
Meals MATTER: A Trial of Medically Tailored Meals 2 Weeks vs. 4 Weeks Post Hospital Discharge
Official Title
Meals MATTER: A Randomized Controlled Trial of Medically Tailored Meals 2 Weeks vs. 4 Weeks Post Hospital Discharge
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
September 8, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Copd, Liver Failure, Diabetes Mellitus, Cancer, End Stage Renal Disease
Keywords
medically tailored meals, chronic conditions, food service

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized trial to compare two approaches to meal delivery. Group 1 will receive meal delivery for 2 weeks (1 meal per day for a total of 14 days) and Group 2 will receive meal delivery for 4 weeks (1 meal per day for a total of 28 days). A concurrent propensity matched control group which will not receive an intervention will also be used.
Masking
Investigator
Allocation
Randomized
Enrollment
650 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meals - 2 weeks
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Meals - 4 weeks
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Medically Tailored Meals
Intervention Description
Compare 2 and 4 weeks of meal delivery
Primary Outcome Measure Information:
Title
Anxiety and Depression measured through the Hospital Anxiety and Depression Scale
Description
Measured through the Hospital Anxiety and Depression Scale. 0 = Minimum. 21 = Maximum. Higher score is worse outcome.
Time Frame
A change in score from baseline to 60 days
Secondary Outcome Measure Information:
Title
Functional Status measured through the Katz Activities of Daily Living Scale
Description
Measured through the Katz Activities of Daily Living. Minimum = 0, Maximum = 6. Higher score is better outcome.
Time Frame
A change in score from baseline to 60 days
Title
Re-hospitalization and Emergency Department Visits
Description
Measured through time of discharge through re-hospitalization or Emergency Department visit
Time Frame
60 days from hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca S Boxer, MD, MS
Organizational Affiliation
KP Institute for Health Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Steiner, MD, MPH
Organizational Affiliation
KP Institute for Health Research
Official's Role
Study Director
Facility Information:
Facility Name
St Joseph's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Good Samaritan Medical Center
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States

12. IPD Sharing Statement

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

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