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

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

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).

Study Overview

• Status: Completed
• Conditions: Heart Failure; Diabetes Mellitus, Type 2; Chronic Kidney Diseases
• Intervention / Treatment: Other: Medically tailored meals

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.

• Study Type: Interventional
• Enrollment (Actual): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94611
      • Kaiser Permanente Northern California
    • San Francisco, California, United States, 94115
      • Kaiser Permanente Northern California
    • San Rafael, California, United States, 94903
      • Kaiser Permanente Northern California
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Northern California
    • Santa Rosa, California, United States, 95403
      • Kaiser Permanente Northern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Other: Medically tailored meals; Compare medically tailored meals vs. medically tailored meals with enhanced nutritional counseling vs. usual care
Active Comparator: 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).	Other: Medically tailored meals; Compare medically tailored meals vs. medically tailored meals with enhanced nutritional counseling vs. usual care
Placebo Comparator: Usual care; Receive usual standard of care.	Other: Medically tailored meals; Compare medically tailored meals vs. medically tailored meals with enhanced nutritional counseling vs. usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-day hospitalization for any cause	Occurrence of an acute hospitalization for any reasons within 90-days after discharge from the index hospitalization.	90-days after discharge from the index hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-day hospitalization related to heart failure	Occurrence of hospitalization for heart failure within 90 days after discharge from the index hospitalization.	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.	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.	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.	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.	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.	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.	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.	90-days after discharge from the index hospitalization

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Alan S Go, MD, Kaiser Permanente Northern California Division of Research

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2020
• Primary Completion (Actual): September 29, 2021
• Study Completion (Actual): September 29, 2021

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Nutritional Counseling; Medically Tailored Meals; Food is Medicine
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Endocrine System Diseases; Diabetes Mellitus; Renal Insufficiency; Diabetes Mellitus, Type 2; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 1527031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No