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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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
Masking
Single (Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
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.
  • Other: Medically Tailored Meals
    Compare 2 and 4 weeks of meal delivery
Active Comparator
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.
  • Other: Medically Tailored Meals
    Compare 2 and 4 weeks of meal delivery

Recruiting Locations

More Details

NCT ID
NCT04351880
Status
Completed
Sponsor
Kaiser Permanente

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.