Chronic Kidney Diseases, Diabetes Mellitus, Type 2, Heart Failure
Conditions
Keywords
Medically Tailored Meals, Nutritional Counseling, Food is Medicine
Brief summary
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
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.
Interventions
Compare medically tailored meals vs. medically tailored meals with enhanced nutritional counseling vs. usual care
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Heart failure 2. Diabetes mellitus 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-day hospitalization for any cause | 90-days after discharge from the index hospitalization | Occurrence of an acute hospitalization for any reasons within 90-days after discharge from the index hospitalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90-day hospitalization related to diabetes | 90-days after discharge from the index hospitalization | Occurrence of hospitalization for a diabetes-related complication within 90 days after discharge from the index hospitalization. |
| 90-day all-cause mortality | 90-days after discharge from the index hospitalization | Occurrence of death from any cause within 90 days after discharge from the index hospitalization. |
| Patient-reported outcomes | 10 weeks after discharge from the index hospitalization | 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. |
| 90-day hospitalization related to heart failure | 90-days after discharge from the index hospitalization | Occurrence of hospitalization for heart failure within 90 days after discharge from the index hospitalization. |
| 30-day hospitalization for any cause | 30-days after discharge from the index hospitalization | Occurrence of hospitalization for any reason within 30 days after discharge from the index hospitalization. |
| 60-day hospitalization for any cause | 60-days after discharge from the index hospitalization | Occurrence of hospitalization for any reason within 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 | 90-days after discharge from the index hospitalization | Occurrence of hospitalization, emergency department visit, or death from any cause within 90 days after discharge from the index hospitalization. |
| Emergency department visit for any cause | 30-, 60- and 90-days after discharge from the index hospitalization | Occurrence of an emergency department visit for any reason within 90 days after discharge from the index hospitalization. |
Countries
United States
Outcome results
None listed