Clinical trial NCT05166525: Kaiser Permanente Evaluation of Medically Tailored Meals in Adults With Medical Conditions at High Readmission Risk
Official title: Kaiser Permanente Evaluation of Medically-Tailored Meals in Adults With Chronic Medical Conditions at High Readmission Risk (KP NOURISH) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Chronic Kidney Diseases
Diabetes Mellitus, Type 2
Keywords: Medically Tailored Meals
Nutritional Counseling
Food is Medicine
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: 90-day hospitalization for any cause
timeFrame: 90-days after discharge from the index hospitalization
Secondary outcomes:
measure: 90-day hospitalization related to heart failure
timeFrame: 90-days after discharge from the index hospitalization
measure: 90-day hospitalization related to diabetes
timeFrame: 90-days after discharge from the index hospitalization
measure: 90-day all-cause mortality
timeFrame: 90-days after discharge from the index hospitalization
measure: Patient-reported outcomes
timeFrame: 10 weeks after discharge from the index hospitalization
measure: Emergency department visit for any cause
timeFrame: 30-, 60- and 90-days after discharge from the index hospitalization
measure: 30-day hospitalization for any cause
timeFrame: 30-days after discharge from the index hospitalization
measure: 60-day hospitalization for any cause
timeFrame: 60-days after discharge from the index hospitalization
measure: 90-day composite of hospitalization for any cause, emergency department visit for any cause or all-cause death
timeFrame: 90-days after discharge from the index hospitalization
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Northern California
state: California
city: San Rafael
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Santa Rosa
country: United States
facility: Kaiser Permanente Northern California
state: California
Study officials:
affiliation: Kaiser Permanente Northern California Division of Research
name: Alan S Go, MD
role: PRINCIPAL_INVESTIGATOR
References: