Meals MATTER: A Randomized Controlled Trial of Medically Tailored Meals 2 Weeks vs. 4 Weeks Post Hospital Discharge
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Kaiser Permanente
- Enrollment
- 650
- Locations
- 2
- Primary Endpoint
- Anxiety and Depression measured through the Hospital Anxiety and Depression Scale
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
- •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
Outcomes
Primary Outcomes
Anxiety and Depression measured through the Hospital Anxiety and Depression Scale
Time Frame: A change in score from baseline to 60 days
Measured through the Hospital Anxiety and Depression Scale. 0 = Minimum. 21 = Maximum. Higher score is worse outcome.
Secondary Outcomes
- Re-hospitalization and Emergency Department Visits(60 days from hospital discharge)
- Functional Status measured through the Katz Activities of Daily Living Scale(A change in score from baseline to 60 days)