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

NCT04351880 | Completed

• 1 other identifier: IRB-1556587
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

medically tailored meals; chronic conditions; food service

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Functional Status measured through the Katz Activities of Daily Living Scale

  A change in score from baseline to 60 days

• Re-hospitalization and Emergency Department Visits

  60 days from hospital discharge

Study Arms (2)

Meals - 2 weeks

ACTIVE COMPARATOR

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

Meals - 4 weeks

ACTIVE COMPARATOR

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

Interventions

Medically Tailored Meals OTHER

Compare 2 and 4 weeks of meal delivery

Meals - 2 weeks; Meals - 4 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (2)

St Joseph's Hospital

Denver, Colorado, 80218, United States

Location

Good Samaritan Medical Center

Lafayette, Colorado, 80026, United States

Location

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive; Liver Failure; Diabetes Mellitus; Neoplasms; Kidney Failure, Chronic; Chronic Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Rebecca S Boxer, MD, MS

  KP Institute for Health Research

  PRINCIPAL INVESTIGATOR

• John Steiner, MD, MPH

  KP Institute for Health Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 17, 2020
• Study Start: April 16, 2020
• Primary Completion: September 8, 2021
• Study Completion: December 31, 2021
• Last Updated: February 17, 2022

Record last verified: 2022-02

Locations

US (2)