Kaiser Permanente Evaluation of Medically Tailored Meals in Adults With Medical Conditions at High Readmission Risk
- Conditions
- Heart FailureChronic Kidney DiseasesDiabetes Mellitus, Type 2
- Interventions
- Other: Medically tailored meals
- Registration Number
- NCT05166525
- Lead Sponsor
- Kaiser Permanente
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2000
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Medically tailored meals plus enhanced nutritional counseling Medically tailored meals 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). Medically tailored meals only Medically tailored meals Receive medically-tailored meals only (1 meal per day for total of 10 weeks) customized to the participant's nutrition-sensitive medical condition(s). Usual care Medically tailored meals Receive usual standard of care.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
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.
Trial Locations
- Locations (1)
Kaiser Permanente Northern California
🇺🇸Santa Rosa, California, United States