Clinical trial NCT04351880: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Copd
Liver Failure
Diabetes Mellitus
Cancer
End Stage Renal Disease
Keywords: medically tailored meals
chronic conditions
food service
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Anxiety and Depression measured through the Hospital Anxiety and Depression Scale
timeFrame: A change in score from baseline to 60 days
Secondary outcomes:
measure: Functional Status measured through the Katz Activities of Daily Living Scale
timeFrame: A change in score from baseline to 60 days
measure: Re-hospitalization and Emergency Department Visits
timeFrame: 60 days from hospital discharge
Other outcomes:
Locations:
city: Denver
country: United States
facility: St Joseph's Hospital
state: Colorado
city: Lafayette
country: United States
facility: Good Samaritan Medical Center
state: Colorado
Study officials:
affiliation: KP Institute for Health Research
name: Rebecca S Boxer, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: KP Institute for Health Research
name: John Steiner, MD, MPH
role: STUDY_DIRECTOR
References: