CommunityRx for Hunger: A Hospital-Based Intervention

NCT03173794 | Withdrawn

• 1 other identifier: IRB17-0770
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Food Insecurity; Caregivers; Clinical Trial; Hunger; Health-Related Quality of Life; Patient Satisfaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change from baseline in mental health-related quality of life

  Baseline, 7 days, 30 days, 60 days, and 90 days

• Change from baseline in household food insecurity

  Baseline, 30 days, 60 days, and 90 days

Other Outcomes (6)

• Change from baseline in caregiver stress

  Baseline, 7 days, 30 days, 60 days, and 90 days

• Change from baseline in caregiver burden

  Baseline, 7 days, 30 days, 60 days, and 90 days

• Change from baseline in caregiving self-efficacy

  Baseline, 7 days, 30 days, 60 days, and 90 days

Study Arms (2)

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

Other: CommunityRx-H

Interventions

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.

Usual Care and Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Recollection of previous receipt of a HealtheRx

Sponsors & Collaborators

• University of Chicago: lead

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Stacy Lindau, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 2, 2017
• Study Start: April 1, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 24, 2020

Record last verified: 2020-04