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CommunityRx for Hunger: A Hospital-Based Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03173794
Recruitment Status : Withdrawn (This trial was a duplicate entry. Recruitment was never open and no participants were enrolled.)
First Posted : June 2, 2017
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Food Insecurity Caregivers Clinical Trial Hunger Health-Related Quality of Life Patient Satisfaction Other: CommunityRx-H Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Other
Official Title: CommunityRx for Hunger: A Children's Hospital-Based Intervention to Support Caregivers in an African American Community
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change from baseline in use of food resources [ Time Frame: 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

  2. Patient satisfaction with care [ Time Frame: 7 days ]
    Patient satisfaction will be measured using the Patient Satisfaction Questionnaire (PSQ-18)


Secondary Outcome Measures :
  1. Change from baseline in mental health-related quality of life [ Time Frame: 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

  2. Change from baseline in household food insecurity [ Time Frame: Baseline, 30 days, 60 days, and 90 days ]
    Household food insecurity will be measured using the 18-item Household Food Security Survey


Other Outcome Measures:
  1. Change from baseline in caregiver stress [ Time Frame: 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

  2. Change from baseline in caregiver burden [ Time Frame: 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

  3. Change from baseline in caregiving self-efficacy [ Time Frame: 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

  4. Change from baseline in contact Community Resource Navigator [ Time Frame: Baseline, 7 days, 30 days, 60 days, and 90 days ]
    Change in contact with Community Resource Navigator will be measured using investigator-generated questions

  5. Satisfaction with navigation [ Time Frame: 7 days ]
    Patient satisfaction with logistical aspects of navigation will be measured using investigator-generated questions

  6. Change in stigma during child's hospital stay [ Time Frame: 7 days, 30 days, 60 days, 90 days ]
    Change in stigma will be measured using the Experiences of Discrimination Scale (EDS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173794


Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Stacy Lindau, MD University of Chicago
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03173794    
Other Study ID Numbers: IRB17-0770
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No