Clinical trial NCT03759925: Cardiac Recovery Through Dietary Support
Official title: Food as Medicine: Providing Medically Appropriate Meals to Patients After Discharge for Congestive Heart Failure Exacerbation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco Department of Public Health
name: San Francisco General Hospital
name: Project Open Hand
First posted: 2018-11-30
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 180 participants will be randomized to the intervention (n=90) or control (n=90) groups, stratified by health care utilization (\<3 vs. \>=3 hospital admissions at ZSFGH) and food security ( zero affirmative answers vs. at least one affirmative answers on the US Department of Agriculture (USDA) 12-question food security screener). The intervention consists of providing home delivery of medically-appropriate food support and individual nutritional counseling over five months to patients at Zuckerberg San Francisco General admitted to the hospital with acute decompensated heart failure.
Primary purpose: OTHER

Brief 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.

Detailed description: The San Francisco Department of Public Health, University of California at San Francisco (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, 1 month 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.

Eligibility criteria: Inclusion Criteria:

* Adults hospitalized at Zuckerberg San Francisco General Hospital (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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Change in the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to one month by study arm
timeFrame: Baseline and one month
measure: Change in the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to five months by study arm
timeFrame: Baseline and five months
measure: Change in the clinical summary Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to one month by study arm
timeFrame: Baseline and one month
measure: Change in the clinical summary Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to five months by study arm
timeFrame: Baseline and five months
measure: Change in the physical domain Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to one month by study arm
timeFrame: Baseline and one month
measure: Change in the physical domain Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to five months by study arm
timeFrame: Baseline and five months
Secondary outcomes:
measure: Hospital admissions from baseline to 1 month, by study arm
timeFrame: Baseline and 1 month
measure: Hospital admissions from baseline to 5 month, by study arm
timeFrame: Baseline and 5 months
measure: Emergency room utilization at any hospital from baseline to 1 month, by study arm.
timeFrame: Baseline and 1 month
measure: Emergency room utilization at any hospital from baseline to 5 month, by study arm.
timeFrame: Baseline and 5 months
measure: Change in overall health-related quality of life from baseline to five months, by study arm
timeFrame: Baseline and five months
measure: Change in food insecurity severity from baseline to one month by study arm
timeFrame: Baseline and 1 month
measure: Change in food insecurity severity from baseline to five months by study arm
timeFrame: Baseline and 5 months
measure: Change in consumption of food high in sodium from baseline to five months by study arm.
timeFrame: Baseline and five moths
measure: Change in consumption of food high in saturated fat consumption from baseline to five months by study arm.
timeFrame: Baseline and five months
measure: Change in medication adherence from baseline to five months, by study arm
timeFrame: Baseline and five months
measure: Change in depressive symptoms from baseline to five months, by study arm
timeFrame: Baseline and five months
Other outcomes:
measure: Hospital admissions to Zuckerberg San Francisco General Hospital from baseline to nine months, by study arm
timeFrame: Baseline and nine months
measure: Emergency room utilization utilization at Zuckerberg San Francisco General Hospital from baseline to nine months by study arm
timeFrame: Baseline and nine months
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General
state: California
Study officials:
affiliation: San Francisco Department of Public Health, UCSF
name: Rita Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Sheri Weiser, MD, MPH, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Kartika Palar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Binh An Phan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campbell AD, Godfryd A, Buys DR, Locher JL. Does Participation in Home-Delivered Meals Programs Improve Outcomes for Older Adults? Results of a Systematic Review. J Nutr Gerontol Geriatr. 2015;34(2):124-67. doi: 10.1080/21551197.2015.1038463.
citation: Ford ES. Food security and cardiovascular disease risk among adults in the United States: findings from the National Health and Nutrition Examination Survey, 2003-2008. Prev Chronic Dis. 2013 Dec 5;10:E202. doi: 10.5888/pcd10.130244.
citation: Gurvey J, Rand K, Daugherty S, Dinger C, Schmeling J, Laverty N. Examining health care costs among MANNA clients and a comparison group. J Prim Care Community Health. 2013 Oct;4(4):311-7. doi: 10.1177/2150131913490737. Epub 2013 Jun 3.
citation: Seligman HK, Jacobs EA, Lopez A, Tschann J, Fernandez A. Food insecurity and glycemic control among low-income patients with type 2 diabetes. Diabetes Care. 2012 Feb;35(2):233-8. doi: 10.2337/dc11-1627. Epub 2011 Dec 30.
citation: Seligman HK, Lyles C, Marshall MB, Prendergast K, Smith MC, Headings A, Bradshaw G, Rosenmoss S, Waxman E. A Pilot Food Bank Intervention Featuring Diabetes-Appropriate Food Improved Glycemic Control Among Clients In Three States. Health Aff (Millwood). 2015 Nov;34(11):1956-63. doi: 10.1377/hlthaff.2015.0641.
citation: Weiser SD, Hatcher A, Frongillo EA, Guzman D, Riley ED, Bangsberg DR, Kushel MB. Food insecurity is associated with greater acute care utilization among HIV-infected homeless and marginally housed individuals in San Francisco. J Gen Intern Med. 2013 Jan;28(1):91-8. doi: 10.1007/s11606-012-2176-4. Epub 2012 Aug 18.
citation: Zilak, J.P. & Gunderson, C. (2014). The health consequences of senior hunger in the United States: Evidence from the 1999-2010 NHANES. Retrieved from: http://www.humsenior.org/dmdocuments/Senior%20Hunger_article.pdf?lbisphpreq=1