Kaiser Permanente Evaluation of Medically Tailored Meals in Adults With Medical Conditions at High Readmission Risk

Study Overview
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Brief Summary
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This study is a virtual, remote, decentralized pragmatic clinical trial comparing the efficacy of medically tailored meals alone or medically tailored meals with remote nutritional counseling compared with usual standard of care in adults with a targeted, nutrition-sensitive chronic medical condition (heart failure, diabetes mellitus, chronic kidney disease).

Detailed Description
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For the KP NOURISH Study, eligible members hospitalized within participating Kaiser Permanente Northern California medical centers will be identified and screened electronically and pre-randomized to 1 of 3 arms (medically tailored meals alone vs. medically tailored meals with remotely delivered enhanced nutritional counseling sessions vs. usual care). Patients enrolled in the medically tailored meals arm will receive 1 medically-tailored meal per day for 10 weeks after hospital discharge. Patients enrolled in the medically tailored meals with enhanced nutritional counseling arm will receive 1 medically-tailored meal per day for 10 weeks after discharge with up to 3 remotely delivered nutritional counseling sessions with a registered dietician nutritionist during the same time period. Patients enrolled in the usual care arm will continue to receive their typical standard of care management. All enrolled patients will complete a questionnaire for patient-reported outcomes (i.e., self-efficacy, social isolation, patient satisfaction, and caring science domains) at baseline and at 10 weeks after discharge and followed electronically for total resource utilization and 30-, 60-, and 90-day outcomes.

Official Title
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Kaiser Permanente Evaluation of Medically-Tailored Meals in Adults With Chronic Medical Conditions at High Readmission Risk (KP NOURISH) Study

Conditions
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Heart Failure, Chronic Kidney Diseases, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Medically tailored meals


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized at Kaiser Permanente Santa Rosa, Santa Clara, San Francisco, Oakland, or San Rafael Medical Centers Kaiser Permanente member at admission Has a prior history of at least one of the following: Heart failure Diabetes mellitus Chronic kidney disease Exclusion Criteria: Receiving primary care at Kaiser Permanente facilities outside of Kaiser Permanente Santa Rosa, Santa Clara, San Francisco, Oakland, or San Rafael Medical Centers Language interpreter needed Admitted from skilled nursing facility or nursing home Homeless at admission Residence outside the geographic area covered by the medically tailored meals vendors Prior history of organ transplant

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 study is a virtual, remote, decentralized pragmatic clinical trial comparing the efficacy of medically tailored meals alone or medically tailored meals with remote nutritional counseling compared with usual standard of care in adults with a targeted, nutrition-sensitive chronic medical condition (heart failure, diabetes mellitus, chronic kidney disease)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medically tailored meals only<br>Receive medically-tailored meals only (1 meal per day for total of 10 weeks) customized to the participant's nutrition-sensitive medical condition(s). | Other: Medically tailored meals<br>* Compare medically tailored meals vs. medically tailored meals with enhanced nutritional counseling vs. usual care<br>|
| Active Comparator: Medically tailored meals plus enhanced nutritional counseling<br>Receive medically-tailored meals only (1 meal per day for total of 10 weeks) with up to 3 remotely delivered enhanced nutritional counseling sessions that are customized to the participant's nutrition-sensitive medical condition(s). | Other: Medically tailored meals<br>* Compare medically tailored meals vs. medically tailored meals with enhanced nutritional counseling vs. usual care<br>|
| Placebo Comparator: Usual care<br>Receive usual standard of care. | Other: Medically tailored meals<br>* Compare medically tailored meals vs. medically tailored meals with enhanced nutritional counseling vs. usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day hospitalization for any cause | Occurrence of an acute hospitalization for any reasons within 90-days after discharge from the index hospitalization. | 90-days after discharge from the index hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day hospitalization related to heart failure | Occurrence of hospitalization for heart failure within 90 days after discharge from the index hospitalization. | 90-days after discharge from the index hospitalization | 
| 90-day hospitalization related to diabetes | Occurrence of hospitalization for a diabetes-related complication within 90 days after discharge from the index hospitalization. | 90-days after discharge from the index hospitalization | 
| 90-day all-cause mortality | Occurrence of death from any cause within 90 days after discharge from the index hospitalization. | 90-days after discharge from the index hospitalization | 
| Patient-reported outcomes | Isolation measured on Likert scale (1-5) for 4 different questions related to feelings of isolation. Self-efficacy measured on Likert scale (1-10) for 4 different questions related to feelings of self-efficacy in maintaining healthy dietary habits. Caring science measured on Likert scale (1-5) one question of the impact of meal delivery programs on feelings of being cared for through food. | 10 weeks after discharge from the index hospitalization | 
| Emergency department visit for any cause | Occurrence of an emergency department visit for any reason within 90 days after discharge from the index hospitalization. | 30-, 60- and 90-days after discharge from the index hospitalization | 
| 30-day hospitalization for any cause | Occurrence of hospitalization for any reason within 30 days after discharge from the index hospitalization. | 30-days after discharge from the index hospitalization | 
| 60-day hospitalization for any cause | Occurrence of hospitalization for any reason within 60 days after discharge from the index hospitalization. | 60-days after discharge from the index hospitalization | 
| 90-day composite of hospitalization for any cause, emergency department visit for any cause or all-cause death | Occurrence of hospitalization, emergency department visit, or death from any cause within 90 days after discharge from the index hospitalization. | 90-days after discharge from the index hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional Counseling, Medically Tailored Meals, Food is Medicine