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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
2,000
Compare medically tailored meals vs. medically tailored meals with enhanced nutritional counseling vs. usual care
Kaiser Permanente Northern California
Oakland, California, United States
Kaiser Permanente Northern California
San Francisco, California, United States
Kaiser Permanente Northern California
San Rafael, California, United States
Kaiser Permanente Northern California
Santa Clara, California, United States
90-day hospitalization for any cause
Occurrence of an acute hospitalization for any reasons within 90-days after discharge from the index hospitalization.
Time frame: 90-days after discharge from the index hospitalization
90-day hospitalization related to heart failure
Occurrence of hospitalization for heart failure within 90 days after discharge from the index hospitalization.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Kaiser Permanente Northern California
Santa Rosa, California, United States
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 90-days after discharge from the index hospitalization