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

Heart Failure Clinical Trial

— KP NOURISH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05166525
• Other study ID #: 1527031
• Status: Completed
• Phase: N/A
• Start date: April 27, 2020
• Est. completion date: September 29, 2021

Study information

• Verified date: December 2021
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: September 29, 2021
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Diabetes Mellitus, Type 2
• Heart Failure
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Medically tailored meals
Compare medically tailored meals vs. medically tailored meals with enhanced nutritional counseling vs. usual care

Locations

Country	Name	City	State
United States	Kaiser Permanente Northern California	Oakland	California
United States	Kaiser Permanente Northern California	San Francisco	California
United States	Kaiser Permanente Northern California	San Rafael	California
United States	Kaiser Permanente Northern California	Santa Clara	California
United States	Kaiser Permanente Northern California	Santa Rosa	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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