Clinical trial NCT04171999: CommunityRx-Hunger
Official title: CommunityRx-Hunger: A Hospital-based Intervention for Primary Caregivers of Children Admitted to the Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Insecurity
Keywords: Food Insecurity
Caregivers
Clinical Trial
Hunger
Self-Efficacy
Health-Related Social Needs
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2019-11-21
Enrollment: 660
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: CommunityRx-Hunger (CRx-H) is a hospital-based intervention that addresses food insecurity and other health-related social needs such as transportation, housing, utilities, and safety. Study team members are recruiting caregivers at the time of their child's hospital admission at a large urban children's hospital. For Aim 1, the primary outcome is self-efficacy among food insecure caregivers compared to those who receive the usual standard of care. For Aim 2, the primary outcome is satisfaction with care compared between food secure and food insecure caregivers.

Detailed description: CommunityRx-Hunger (CRx-H) is a double-blinded randomized controlled trial aimed at increasing self-efficacy among caregivers with food insecurity in the household. CRx-H is recruiting primary caregivers of hospitalized children at a large urban children's hospital at the time of admission. Aim 1: Researchers are studying whether the intervention will increase self-efficacy among food insecure caregivers compared to those who receive the usual standard of care. Aim 2: Researchers will enroll and randomize caregivers with and without food insecurity to the intervention to compare satisfaction with care.

Eligible, self-identified caregivers will complete a baseline survey during the child's hospital stay, followed by phone surveys at 7, 30, 90, 180 days, and 12 months. Caregivers randomized to the intervention will receive a tailored list of resources to address food insecurity and other health-related social needs, plus a brief educational component delivered by a trained member of our research team. Cases will receive a "booster" dose of the resource list prior to discharge. After discharge, cases will receive proactive text messages about those same community resources.

All caregivers (regardless of research arm) will receive a series of text messages related to the study such as reminders to schedule the phone survey with a member of the research team.

Eligibility criteria: Inclusion Criteria:

* Native English or Spanish speaker
* Living in 1 of 27 zip codes in the study's target region
* Self-identify as a primary caregiver of a child \<18 years old hospitalized in a large urban children's hospital
* Ability to send and receive text messages
* Access to a mobile phone and agrees to receive text messages from the study

Exclusion Criteria:

* Previous participation in a CRx research study.
* Caregivers of newborns in the hospital
* Patient hospital stay is less than 24 hours
* Patient hospital stay is 30 days or more
* Patient has an eating disorder as indicated in the EMR

Primary outcomes:
measure: (Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers
timeFrame: 12 months
measure: (Aim 2) Caregiver Satisfaction With Hospital Discharge
timeFrame: 7 days post discharge from the hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Stacy T Lindau, MD, MPP
role: PRINCIPAL_INVESTIGATOR
References: