Cardiac Recovery Through Dietary Support

a study on Heart Failure

Summary

for people ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion
Rita Nguyen, MD Sheri Weiser, MD, MPH, MA Kartika Palar Binh An Phan, MD

Description

Summary

This is a prospective, randomized, wait-list controlled study examining the impact of providing medically appropriate meals to patients discharged from Zuckerberg San Francisco General Hospital after acute decompensated heart failure. Upon discharge, patients will be randomized to either the intervention or wait list control arm. The intervention is the delivery of medically appropriate meals and groceries to patients' homes in a tapered manner over five months (the equivalent of three meals a day for 60 days, then the equivalent of two meals a day for 30 days, then the equivalent of one meal a day for 60 days) and monthly assessments with a registered dietician (RD). All food and RD assessments are administered via a community partner, Project Open Hand, as a modification of current offerings for clients at Project Open Hand. Subjects randomized into the wait list control arm will receive the food intervention five months after discharge. The study's primary aim is to examine the impact of nutritional support on the Kansas City Cardiomyopathy Questionnaire scores. In addition, the study aims to examine the impact of nutritional support on healthcare utilization (particularly readmission rates and emergency room utilization), dietary change, medication adherence, and quality of life.

Official Title

Food as Medicine: Providing Medically Appropriate Meals to Patients After Discharge for Congestive Heart Failure Exacerbation

Details

The San Francisco Department of Public Health, UCSF, and Project Open Hand (POH), a community based organization in San Francisco which provides meals and groceries to chronically ill clients in the Bay Area, have partnered to conduct a prospective, randomized, wait-list controlled study examining the impact of providing medically appropriate meals and registered dietician (RD) support to patients discharged from Zuckerberg San Francisco General Hospital after acute decompensated heart failure. Before discharge, patients will be randomized to either the intervention or wait list control arm. The intervention consists of the delivery of medically appropriate meals and/or groceries to participants' homes in a tapered manner over five months (the equivalent of three meals a day for 60 days, then the equivalent of two meals a day for 30 days, then the equivalent of one meal a day for 60 days) and monthly nutrition education with a registered dietician (RD). All food and nutritional education are administered by POH staff and RDs. Participants randomized into the wait list control arm will receive the food intervention five months after discharge. The study's primary aim is to examine the impact of nutritional support on the Kansas City Cardiomyopathy Questionnaire scores. In addition, the study aims to examine the impact of nutritional support on healthcare utilization (particularly readmission rates and emergency room utilization), dietary change, medication adherence, and quality of life. The investigators will assess outcomes at baseline while patients are hospitalized, 2 months after discharge, and 5 months after discharge using quantitative surveys. The investigators will call participants at 3 months and 4 months after discharge with a shorter quantitative survey assessing a subset of outcome measures. In addition, the investigators will conduct a qualitative interview near the conclusion of the intervention in a subset of participants to understand perceived impacts of the intervention as well as barriers and facilitators to heart failure care.

Keywords

Heart Failure Nutritional Support

Eligibility

You can join if…

Open to people ages 18 years and up

  • Adults hospitalized at ZSFG with acute decompensated heart failure/congestive heart failure exacerbation
  • Adults with their primary residence within San Francisco
  • Age: >18 years old
  • Languages: English or Spanish
  • Housed at a location where they would be able to securely receive, store and reheat food

You CAN'T join if...

  • Patients with severe or critical aortic stenosis.
  • Patients with six or more hospital admissions within the last twelve months
  • Patients who are being discharged to a living facility that provides meals to residents.
  • Patients who anticipate moving from their current housing situation to one that does not meet our inclusion criteria within six months of enrollment.
  • Patients who are part of meal provision program that provides more than 7 meals a week to the patient.
  • Patients who are unable to feed themselves and do not have adequate support to help them with feeding.
  • Patients with limited physical, cognitive, or behavioral abilities that would interfere with their ability to follow-up with a study as determined by their ability to receive the Project Open Hand services and follow up with survey interviews
  • Patients with anticipated life expectancy of less than a year.
  • Patients who lack capacity to consent to a research study.
  • Patients currently requiring dialysis or determined to be in need of dialysis in the next 6 months.
  • Patients with severe allergies to eggs, soy, wheat, nuts, seeds, seed oils, pineapple, raisins, or certain vegetables such as onions (allergies are considered on a case-by-case basis in consultation with Project Open Hand).

Location

  • Zuckerberg San Francisco General accepting new patients
    San Francisco California 94110 United States

Lead Scientists

  • Rita Nguyen, MD
    Dr. Nguyen is a Bay Area native whose interests are founded on a desire to unite the humanitarian promise of medicine with the pursuit of social justice. Her public service work has been primarily community-based and focused on addressing inequities faced by underserved communities.
  • Sheri Weiser, MD, MPH, MA
    Sheri Weiser, MD, MPH, MA, is an Associate Professor of Medicine and internist at UC San Francisco’s Division of HIV, Infectious Diseases and Global Medicine at Zuckerberg San Francisco General Hospital. Her research focuses on the impact of food insecurity and other social and structural factors on treatment outcomes for HIV and other chronic diseases.
  • Kartika Palar
  • Binh An Phan, MD
    Professor, Medicine. Authored (or co-authored) 23 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03759925
Study Type
Interventional
Last Updated