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

Kaiser Permanente

Status: Completed

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

Treatments: Other: Medically Tailored Meals

Study type: Interventional

Funder types: Other

Identifiers

NCT04351880

IRB-1556587

Details and patient eligibility

About

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.

Full 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.

Enrollment: 650 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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650 participants in 2 patient groups

Meals - 2 weeks

Active Comparator group

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.

Treatment:

Other: Medically Tailored Meals

Meals - 4 weeks

Active Comparator group

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.

Treatment:

Other: Medically Tailored Meals