CommunityRx-Hunger

NCT04171999 | Completed Results

• 2 other identifiers: IRB20-03241R01MD012630-01A1
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Insecurity

Keywords

Food Insecurity; Caregivers; Clinical Trial; Hunger; Self-Efficacy; Health-Related Social Needs

Outcome Measures

Primary Outcomes (2)

• (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."

  12 months

• (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.

  7 days post discharge from the hospital

Study Arms (2)

Usual Care + Intervention (Case)

EXPERIMENTAL

Cases will receive the CommunityRx Intervention.

Other: Community Rx-Hunger (CRx-H)

Usual Care (Control)

NO INTERVENTION

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.

Interventions

Community Rx-Hunger (CRx-H) OTHER

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.

Usual Care + Intervention (Case)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (4)

• Lindau ST, Makelarski JA, Winslow VA, Abramsohn EM, Anand V, Burnet DL, Fuller CM, Grana M, Miller DC, Ren ES, Waxman E, Wroblewski KE. Low-Intensity Social Care and Child Acute Health Care Utilization: A Randomized Clinical Trial. JAMA Pediatr. 2025 Jun 1;179(6):610-620. doi: 10.1001/jamapediatrics.2025.0484.

  PMID: 40293738 DERIVED

• Glasser NJ, Lindau ST, Wroblewski K, Abramsohn EM, Burnet DL, Fuller CM, Miller DC, O'Malley CA, Shiu E, Waxman E, Makelarski JA; CommunityRx-Hunger Collaborators. Effect of a Social Care Intervention on Health Care Experiences of Caregivers of Hospitalized Children: A Randomized Clinical Trial. JAMA Pediatr. 2023 Dec 1;177(12):1266-1275. doi: 10.1001/jamapediatrics.2023.4596.

  PMID: 37902777 DERIVED

• Abramsohn EM, De Ornelas M, Borson S, Frazier CRM, Fuller CM, Grana M, Huang ES, Jagai JS, Makelarski JA, Miller D, Schulman-Green D, Shiu E, Thompson K, Winslow V, Wroblewski K, Lindau ST. CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials. Trials. 2023 Oct 21;24(1):681. doi: 10.1186/s13063-023-07697-z.

  PMID: 37864258 DERIVED

• Abramsohn EM, De Ornelas M, Borson S, Frazier CR, Fuller CM, Grana M, Huang ES, Jagai JS, Makelarski JA, Miller D, Schulman-Green D, Shiu E, Thompson K, Winslow V, Wroblewski K, Lindau ST. Two concurrent randomized controlled trials of CommunityRx, a social care intervention for family and friend caregivers delivered at the point of care. Res Sq [Preprint]. 2023 Mar 1:rs.3.rs-2464681. doi: 10.21203/rs.3.rs-2464681/v1.

  PMID: 36909590 DERIVED

Results Point of Contact

• Title: Emily Abramsohn
• Organization: University of Chicago

eabramsohn@bsd.uchicago.edu

7738344832

Study Officials

• Stacy T Lindau, MD, MPP

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: January 6, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 27, 2024
• Results First Posted: December 27, 2024

Record last verified: 2023-11

Locations

US (1)