CommunityRx for Hunger: A Hospital-Based Intervention

CommunityRx for Hunger: A Children's Hospital-Based Intervention to Support Caregivers in an African American Community

The goal of this research program is to reduce health disparities by deploying an information-based intervention to increase caregiver utilization of community-based food supports and satisfaction with care among food insecure caregivers of hospitalized children. We will conduct a randomized controlled trial to evaluate, versus usual care, the effects of the CommunityRx-H intervention on caregiver use of food resources (primary), caregiver patient satisfaction with care (primary), caregiver mental health-related quality of life (secondary), and caregiver household food security (secondary). The proposed research will yield an understanding of how to leverage a child's hospitalization to effectively intervene on the problem of food insecurity. Findings will inform the rapidly growing field of healthcare-based interventions to address health-related social needs.

Study Overview

• Status: Withdrawn
• Conditions: Food Insecurity; Patient Satisfaction; Clinical Trial; Hunger; Caregivers; Health-Related Quality of Life
• Intervention / Treatment: Other: CommunityRx-H

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 18 years old
• English-speaking
• Living in 1 of the 16 ZIP code target regions
• Self-identify as a primary caregiver of a child <18 years old hospitalized in CCH's general, intensive care or transplant units

Exclusion Criteria:

• Recollection of previous receipt of a HealtheRx

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care Only; The control group will receive usual care, no CommunityRx-H intervention
Experimental: Usual Care and Intervention; The intervention arm will receive the CommunityRx-H intervention, an information-based intervention that provides referrals to community resources	Other: CommunityRx-H; CommunityRx-H has two components: (1) health-information technology (HIT) e-prescribing, and (2) a Community Resource Specialist (CRS). CommunityRx functions like an e-prescribing system: a HealtheRx "prescription" is automatically generated at the point of care. The HealtheRx provides referrals to food resources and federal nutrition assistance information tailored to the caregiver's address and proactive social support in the form of SMS-text message nudges from the CRS. Caregivers in the intervention arm are able to request information on resources not limited to food, including employment support, help paying rent or mortgage, etc. Nudges will promote caregiver self- and family management by increasing knowledge of and encouraging activation of community resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in use of food resources	Change in use of food resources will be measured using investigator-generated questions about use of the resources for self or others, sharing of information about the resources	Baseline, 7 days, 30 days, 60 days, and 90 days
Patient satisfaction with care	Patient satisfaction will be measured using the Patient Satisfaction Questionnaire (PSQ-18)	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in mental health-related quality of life	Mental health-related quality of life will be measured using the Medical Outcomes Study Short Form-36	Baseline, 7 days, 30 days, 60 days, and 90 days
Change from baseline in household food insecurity	Household food insecurity will be measured using the 18-item Household Food Security Survey	Baseline, 30 days, 60 days, and 90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in caregiver stress	Caregiver stress will be measured using the Perceived Stress Scale (PSS). Measure is included in the NIH Common Data Element Repository	Baseline, 7 days, 30 days, 60 days, and 90 days
Change from baseline in caregiver burden	Caregiver burden will be measured using the Caregiver Burden Scale (CGBS). Measure is included in the NIH Common Data Element Repository	Baseline, 7 days, 30 days, 60 days, and 90 days
Change from baseline in caregiving self-efficacy	Caregiver self-efficacy will be measured using General Self-Efficacy Scale (GSE). Measure is included in the NIH Common Data Element Repository	Baseline, 7 days, 30 days, 60 days, and 90 days
Change from baseline in contact Community Resource Navigator	Change in contact with Community Resource Navigator will be measured using investigator-generated questions	Baseline, 7 days, 30 days, 60 days, and 90 days
Satisfaction with navigation	Patient satisfaction with logistical aspects of navigation will be measured using investigator-generated questions	7 days
Change in stigma during child's hospital stay	Change in stigma will be measured using the Experiences of Discrimination Scale (EDS)	7 days, 30 days, 60 days, 90 days

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Stacy Lindau, MD, University Of Chicago

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRB17-0770

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No