Food InsecurityNCT03173794
CommunityRx for Hunger: A Hospital-Based Intervention
A study testing CommunityRx-H in people with Food Insecurity and Caregivers, run by University of Chicago.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity, Caregivers, Clinical Trial
- What is being tested?
- CommunityRx-H
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Recollection of previous receipt of a HealtheRx
About this study
Official title: CommunityRx for Hunger: A Children's Hospital-Based Intervention to Support Caregivers in an African American Community
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
- Being tested
- CommunityRx-H
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CommunityRx-HOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: CommunityRx-H |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 7 days
Secondary outcomes (2)
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
Measured: Baseline, 7 days, 30 days, 60 days, and 90 days
Change from baseline in household food insecurity
Household food insecurity will be measured using the 18-item Household Food Security Survey
Measured: Baseline, 30 days, 60 days, and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study startApr 2018 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: This trial was a duplicate entry. Recruitment was never open and no participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacy Lindau, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173794
- Sponsor's protocol ID
- IRB17-0770
- Status last verified
- Apr 2020
- First submitted
- 30 May 2017
- Last updated
- 24 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CommunityRx for Hunger: A Children's Hospital-Based Intervention to Support Caregivers in an African American Community
- ClinicalTrials.gov ID
- NCT03173794
- Acronym / sponsor ID
- IRB17-0770
- Conditions
- Food Insecurity, Caregivers, Clinical Trial, Hunger, Health-Related Quality of Life, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This trial was a duplicate entry. Recruitment was never open and no participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Only | No intervention | –The control group will receive usual care, no CommunityRx-H intervention |
| Usual Care and Intervention | Experimental | Other: CommunityRx-HThe intervention arm will receive the CommunityRx-H intervention, an information-based intervention that provides referrals to community resources |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Recollection of previous receipt of a HealtheRx
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CommunityRx-HCommunityRx-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. | Other | Usual Care and Intervention |
Primary outcome
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
Patient satisfaction with care
Time frame: 7 days
Patient satisfaction will be measured using the Patient Satisfaction Questionnaire (PSQ-18)
2 secondary outcomes
Change from baseline in mental health-related quality of life
Time frame: Baseline, 7 days, 30 days, 60 days, and 90 days
Change from baseline in household food insecurity
Time frame: Baseline, 30 days, 60 days, and 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacy Lindau, MD principal investigator
University of Chicago
Questions about this trial
What is this clinical trial studying?
A study testing CommunityRx-H in people with Food Insecurity and Caregivers, run by University of Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in use of food resources (time frame: Baseline, 7 days, 30 days, 60 days, and 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.