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NCT Number: NCT05166525

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

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).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Chronic Disease Chronic Kidney Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Heart Diseases Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Northern California, Oakland, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Heart failure
  • Diabetes mellitus
  • 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

Treatment and study plan

Medically Tailored Meals

Other

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

Primary outcomes

  1. 90-day hospitalization for any cause

    Time frame: 90-days after discharge from the index hospitalization

    Occurrence of an acute hospitalization for any reasons within 90-days after discharge from the index hospitalization.

Secondary outcomes

  1. 90-day hospitalization related to heart failure

    Time frame: 90-days after discharge from the index hospitalization

    Occurrence of hospitalization for heart failure within 90 days after discharge from the index hospitalization.

  2. 90-day hospitalization related to diabetes

    Time frame: 90-days after discharge from the index hospitalization

    Occurrence of hospitalization for a diabetes-related complication within 90 days after discharge from the index hospitalization.

  3. 90-day all-cause mortality

    Time frame: 90-days after discharge from the index hospitalization

    Occurrence of death from any cause within 90 days after discharge from the index hospitalization.

  4. Patient-reported outcomes

    Time frame: 10 weeks after discharge from the index hospitalization

    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.

  5. Emergency department visit for any cause

    Time frame: 30-, 60- and 90-days after discharge from the index hospitalization

    Occurrence of an emergency department visit for any reason within 90 days after discharge from the index hospitalization.

  6. 30-day hospitalization for any cause

    Time frame: 30-days after discharge from the index hospitalization

    Occurrence of hospitalization for any reason within 30 days after discharge from the index hospitalization.

  7. 60-day hospitalization for any cause

    Time frame: 60-days after discharge from the index hospitalization

    Occurrence of hospitalization for any reason within 60 days after discharge from the index hospitalization.

  8. 90-day composite of hospitalization for any cause, emergency department visit for any cause or all-cause death

    Time frame: 90-days after discharge from the index hospitalization

    Occurrence of hospitalization, emergency department visit, or death from any cause within 90 days after discharge from the index hospitalization.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

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

Acronym: KP NOURISH

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2021
Registry last updated
Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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