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

NCT ID: NCT04351880

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 650 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-16
• Study Completion Date: 2021-12-31

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.

Conditions

Heart Failure; Copd; Liver Failure; Diabetes Mellitus; Cancer; End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Medically Tailored Meals

Intervention Type: OTHER

Compare 2 and 4 weeks of meal delivery

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.

Group Type: ACTIVE_COMPARATOR

Medically Tailored Meals

Intervention Type: OTHER

Compare 2 and 4 weeks of meal delivery

Interventions

Medically Tailored Meals

Compare 2 and 4 weeks of meal delivery

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca S Boxer, MD, MS

Role: PRINCIPAL_INVESTIGATOR

KP Institute for Health Research

John Steiner, MD, MPH

Role: STUDY_DIRECTOR

KP Institute for Health Research

Locations

St Joseph's Hospital

Denver, Colorado, United States

Good Samaritan Medical Center

Lafayette, Colorado, United States

Countries

United States

Other Identifiers

IRB-1556587

Identifier Type: -

Identifier Source: org_study_id