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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03173794
Other study ID # IRB17-0770
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 2018
Est. completion date September 2021

Study information

Verified date April 2020
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2021
Est. primary completion date September 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other 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
Other 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
Other Satisfaction with navigation Patient satisfaction with logistical aspects of navigation will be measured using investigator-generated questions 7 days
Other 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
Primary 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
Primary Patient satisfaction with care Patient satisfaction will be measured using the Patient Satisfaction Questionnaire (PSQ-18) 7 days
Secondary 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
Secondary 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
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