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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04351880
• Other study ID #: IRB-1556587
• Status: Completed
• Phase: N/A
• Start date: April 16, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: December 31, 2021
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Copd
• Diabetes Mellitus
• End Stage Renal Disease
• Heart Failure
• Kidney Failure, Chronic
• Liver Failure

Intervention

Other:
• Medically Tailored Meals
Compare 2 and 4 weeks of meal delivery

Locations

Country	Name	City	State
United States	St Joseph's Hospital	Denver	Colorado
United States	Good Samaritan Medical Center	Lafayette	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Re-hospitalization and Emergency Department Visits	Measured through time of discharge through re-hospitalization or Emergency Department visit	60 days from hospital discharge