Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
660 participants
INTERVENTIONAL
2020-01-06
2023-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
Yes
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Stacy T Lindau, MD, MPP
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago
Chicago, Illinois, United States
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB20-0324
Identifier Type: -
Identifier Source: org_study_id