Meals MATTER: A Trial of Medically Tailored Meals 2 Weeks vs. 4 Weeks Post Hospital Discharge
- Conditions
- Liver FailureCopdDiabetes MellitusCancerEnd Stage Renal DiseaseHeart Failure
- Interventions
- Other: Medically Tailored Meals
- Registration Number
- NCT04351880
- Lead Sponsor
- Kaiser Permanente
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 650
-
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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Meals - 2 weeks Medically Tailored Meals 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. Meals - 4 weeks Medically Tailored Meals 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.
- Primary Outcome Measures
Name Time Method Anxiety and Depression measured through the Hospital Anxiety and Depression Scale 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 Outcome Measures
Name Time Method Re-hospitalization and Emergency Department Visits 60 days from hospital discharge Measured through time of discharge through re-hospitalization or Emergency Department visit
Functional Status measured through the Katz Activities of Daily Living Scale A change in score from baseline to 60 days Measured through the Katz Activities of Daily Living. Minimum = 0, Maximum = 6. Higher score is better outcome.
Trial Locations
- Locations (2)
Good Samaritan Medical Center
🇺🇸Lafayette, Colorado, United States
St Joseph's Hospital
🇺🇸Denver, Colorado, United States