Food Insecurity
Conditions
Keywords
Food Insecurity, Caregivers, Clinical Trial, Hunger, Self-Efficacy, Health-Related Social Needs
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.
Interventions
OTHERCommunity Rx-Hunger (CRx-H)
The CRx-H Intervention provides "dosages" of health content that offer assistance for food insecurity and other health-related social needs. A caregiver randomized to the intervention will receive a hard-copy print-out of their tailored list of resources to address food insecurity. A member of our research team will deliver this list and provide a brief educational component which includes: a brief, structured script about the common problem of food insecurity in households with children and co-occuring HRSNs, review of the resource list which includes nearby, vetted resources to address these needs and coaching on how to activate resources on the list. Prior to discharge, the caregiver will receive a duplicate copy of the list of resources. After discharge, the caregiver will receive text messages at a frequency based on the Critical Time Intervention (CTI) Model, from baseline to 3 months post discharge, in order to receive ongoing support by a research team member.
Sponsors
University of Chicago
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double-Blind randomized controlled trial where the data collectors are blinded to the condition to which the subject has been assigned. The subject is also blinded to the condition they are assigned.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers | 12 months | Self-efficacy is measured by Bandura's Self-Efficacy Scale which asks, "How confident are you in your ability to find resources in your community that help you manage your health?" Responses will be assessed on a 5-point Likert scale ranging from "not at all confident" to "completely confident." |
| (Aim 2) Caregiver Satisfaction With Hospital Discharge | 7 days post discharge from the hospital | Satisfaction with hospital discharge is measured by the Hospital Consumer Assessment of Healthcare Providers Survey (HCAHPS); "Child HCAHPS" which includes 8 items (range 0-100 with higher values representing higher satisfaction). Response options are "Yes, definitely," "Yes, somewhat" and "No." The items ask about the child and the hospital related to their recent stay. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStacy T Lindau, MD, MPP
University of Chicago
Participant flow
Pre-assignment details
Prior to the randomized trial, 20 participants were enrolled as part of pre-testing.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care + Intervention (Case) Cases will receive the CommunityRx Intervention.
Community Rx-Hunger (CRx-H): The CRx-H Intervention provides dosages of health content that offer assistance for food insecurity and other health-related social needs. A caregiver randomized to the intervention will receive a hard-copy print-out of their tailored list of resources to address food insecurity. A member of our research team will deliver this list and provide a brief educational component which includes: a brief, structured script about the common problem of food insecurity in households with children and co-occuring HRSNs, review of the resource list which includes nearby, vetted resources to address these needs and coaching on how to activate resources on the list. Prior to discharge, the caregiver will receive a duplicate copy of the list of resources. After discharge, the caregiver will receive text messages at a frequency based on the Critical Time Intervention (CTI) Model, from baseline to 3 months post discharge, in order to receive ongoing support by a research team member. | 318 |
| Usual Care (Control) Controls will receive the usual standard care, which consists of information about hospital food resources and access to Feed1st hospital food pantries prior to discharge. | 319 |
| Total | 637 |
Baseline characteristics
| Characteristic | Usual Care + Intervention (Case) | Total | Usual Care (Control) |
|---|---|---|---|
| Age, Continuous | 35.2 years STANDARD_DEVIATION 9.2 | 35 years STANDARD_DEVIATION 9.2 | 34.9 years STANDARD_DEVIATION 9.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 51 Participants | 92 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 267 Participants | 545 Participants | 278 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 246 Participants | 505 Participants | 259 Participants |
| Race/Ethnicity, Customized More than one race | 6 Participants | 18 Participants | 12 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 25 Participants | 44 Participants | 19 Participants |
| Race/Ethnicity, Customized Unknown or not reported | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 36 Participants | 63 Participants | 27 Participants |
| Sex: Female, Male Female | 298 Participants | 600 Participants | 302 Participants |
| Sex: Female, Male Male | 18 Participants | 35 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 318 | 0 / 319 |
| other Total, other adverse events | 0 / 318 | 0 / 319 |
| serious Total, serious adverse events | 0 / 318 | 0 / 319 |
Outcome results
Primary
(Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers
Self-efficacy is measured by Bandura's Self-Efficacy Scale which asks, How confident are you in your ability to find resources in your community that help you manage your health? Responses will be assessed on a 5-point Likert scale ranging from not at all confident to completely confident.
Time frame: 12 months
Population: Analysis was restricted to caregivers who were food insecure at baseline and who completed the self-efficacy measure at 12 month follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care + Intervention (Case) | (Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers | Not very confident | 9 Participants |
| Usual Care + Intervention (Case) | (Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers | Somewhat confident | 18 Participants |
| Usual Care + Intervention (Case) | (Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers | Uncertain | 13 Participants |
| Usual Care + Intervention (Case) | (Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers | Completely confident | 32 Participants |
| Usual Care + Intervention (Case) | (Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers | Not at all confident | 2 Participants |
| Usual Care (Control) | (Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers | Completely confident | 26 Participants |
| Usual Care (Control) | (Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers | Not at all confident | 5 Participants |
| Usual Care (Control) | (Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers | Not very confident | 4 Participants |
| Usual Care (Control) | (Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers | Uncertain | 6 Participants |
| Usual Care (Control) | (Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers | Somewhat confident | 33 Participants |
Primary
(Aim 2) Caregiver Satisfaction With Hospital Discharge
Satisfaction with hospital discharge is measured by the Hospital Consumer Assessment of Healthcare Providers Survey (HCAHPS); Child HCAHPS which includes 8 items (range 0-100 with higher values representing higher satisfaction). Response options are Yes, definitely, Yes, somewhat and No. The items ask about the child and the hospital related to their recent stay.
Time frame: 7 days post discharge from the hospital
Population: Caregivers who completed the satisfaction measure at the 1 week follow up are included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care + Intervention (Case) | (Aim 2) Caregiver Satisfaction With Hospital Discharge | 81.9 units on a scale | Standard Deviation 24.8 |
| Usual Care (Control) | (Aim 2) Caregiver Satisfaction With Hospital Discharge | 84.2 units on a scale | Standard Deviation 23.8 |