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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Medically Tailored Meals


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Meals - 2 weeks<br>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<br>* Compare 2 and 4 weeks of meal delivery<br>|
| Active Comparator: Meals - 4 weeks<br>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<br>* Compare 2 and 4 weeks of meal delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Status measured through the Katz Activities of Daily Living Scale | Measured through the Katz Activities of Daily Living. Minimum = 0, Maximum = 6. Higher score is better outcome. | A change in score from baseline to 60 days | 
| Re-hospitalization and Emergency Department Visits | Measured through time of discharge through re-hospitalization or Emergency Department visit | 60 days from hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic conditions, medically tailored meals, food service