Caregivers, Clinical Trial, Food Insecurity, Health-Related Quality of Life, Hunger, Patient Satisfaction
Conditions
Brief 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.
Interventions
OTHERCommunityRx-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.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in use of food resources | Baseline, 7 days, 30 days, 60 days, and 90 days | 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 |
| Patient satisfaction with care | 7 days | Patient satisfaction will be measured using the Patient Satisfaction Questionnaire (PSQ-18) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in mental health-related quality of life | Baseline, 7 days, 30 days, 60 days, and 90 days | Mental health-related quality of life will be measured using the Medical Outcomes Study Short Form-36 |
| Change from baseline in household food insecurity | Baseline, 30 days, 60 days, and 90 days | Household food insecurity will be measured using the 18-item Household Food Security Survey |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with navigation | 7 days | Patient satisfaction with logistical aspects of navigation will be measured using investigator-generated questions |
| Change from baseline in caregiver stress | Baseline, 7 days, 30 days, 60 days, and 90 days | Caregiver stress will be measured using the Perceived Stress Scale (PSS). Measure is included in the NIH Common Data Element Repository |
| Change in stigma during child's hospital stay | 7 days, 30 days, 60 days, 90 days | Change in stigma will be measured using the Experiences of Discrimination Scale (EDS) |
| Change from baseline in caregiver burden | Baseline, 7 days, 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 |
| Change from baseline in caregiving self-efficacy | Baseline, 7 days, 30 days, 60 days, and 90 days | Caregiver self-efficacy will be measured using General Self-Efficacy Scale (GSE). Measure is included in the NIH Common Data Element Repository |
| Change from baseline in contact Community Resource Navigator | Baseline, 7 days, 30 days, 60 days, and 90 days | Change in contact with Community Resource Navigator will be measured using investigator-generated questions |
Outcome results
None listed