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

NCT ID: NCT05166525

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-27

Study Completion Date

2021-09-29

Brief Summary

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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

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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.

Conditions

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Heart Failure Chronic Kidney Diseases Diabetes Mellitus, Type 2

Keywords

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Medically Tailored Meals Nutritional Counseling Food is Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Medically tailored meals only

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

Group Type ACTIVE_COMPARATOR

Medically tailored meals

Intervention Type OTHER

Compare medically tailored meals vs. medically tailored meals with enhanced nutritional counseling vs. usual care

Medically tailored meals plus enhanced nutritional counseling

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).

Group Type ACTIVE_COMPARATOR

Medically tailored meals

Intervention Type OTHER

Compare medically tailored meals vs. medically tailored meals with enhanced nutritional counseling vs. usual care

Usual care

Receive usual standard of care.

Group Type PLACEBO_COMPARATOR

Medically tailored meals

Intervention Type OTHER

Compare medically tailored meals vs. medically tailored meals with enhanced nutritional counseling vs. usual care

Interventions

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Medically tailored meals

Compare medically tailored meals vs. medically tailored meals with enhanced nutritional counseling vs. usual care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alan S Go, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente Northern California Division of Research

Locations

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Kaiser Permanente Northern California

Oakland, California, United States

Site Status

Kaiser Permanente Northern California

San Francisco, California, United States

Site Status

Kaiser Permanente Northern California

San Rafael, California, United States

Site Status

Kaiser Permanente Northern California

Santa Clara, California, United States

Site Status

Kaiser Permanente Northern California

Santa Rosa, California, United States

Site Status

Countries

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United States

Other Identifiers

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1527031

Identifier Type: -

Identifier Source: org_study_id