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This trial was a duplicate entry. Recruitment was never open and no participants were enrolled.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Only | No Intervention | The control group will receive usual care, no CommunityRx-H intervention | |
| Usual Care and Intervention | Experimental | The intervention arm will receive the CommunityRx-H intervention, an information-based intervention that provides referrals to community resources |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CommunityRx-H | Other | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacy Lindau, MD | University of Chicago | Principal Investigator |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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Household food insecurity will be measured using the 18-item Household Food Security Survey |
| Baseline, 30 days, 60 days, and 90 days |
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 |