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

Kaiser Permanente

Status: Completed

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

Treatments: Other: Medically tailored meals

Study type: Interventional

Funder types: Other

Identifiers

NCT05166525

1527031

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,000 participants in 3 patient groups, including a placebo group

Medically tailored meals only

Active Comparator group

Description:

Receive medically-tailored meals only (1 meal per day for total of 10 weeks) customized to the participant's nutrition-sensitive medical condition(s).

Treatment:

Other: Medically tailored meals

Medically tailored meals plus enhanced nutritional counseling

Active Comparator group

Description:

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).

Treatment:

Other: Medically tailored meals

Usual care

Placebo Comparator group

Description:

Receive usual standard of care.

Treatment:

Other: Medically tailored meals