- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04739540
Food Insecurity Screening and Intervention: From Hospital to Home
Study Overview
Status
Conditions
Detailed Description
Screening / Enrollment: At enrollment the research coordinator will create daily epic report list, maintain notes on eligible subjects obtain informed consent, verify eligibility, have caregiver complete demographics questionnaire in REDCap, and have caregiver complete food insecurity survey in REDCap. Research coordinator will notify investigator of + FI screen based on score of 3 or higher for household or inpatient tallied in REDCap. Research coordinator to activate the Admission/Discharge/Transfers (ADT) notice in Epic and link the subjects child in order to be notified when subjects child is discharged. The investigator will verify the score for food insecurity positive caregivers and the investigator will order the caregiver tray or notify the RC that the RC can order the caregiver tray for FI positive caregivers in Epic. The RC will complete a brief study note in Epic to state the caregiver was enrolled in the study. The investigator will complete the referral to Texas Children's Hospital food bank representative. Parents will receive handouts on caregiver tray, guest tray, hospital food resources, and the FIRST link program with the Houston food bank phone number (found in attachments).
All study procedures will be completed after informed consent is obtained. If a caregiver declines to participate in the study or screens negative for FI, they will still have the option to meet with with social work who is able to provide FI resources including caregiver trays, food bank referrals, educational materials, and gift cards depending on the social workers assessment.
Follow up: Research coordinator will complete the follow up survey with caregiver 2 weeks after discharge. Subjects should be called daily (Mon-Friday) due to short window for follow up (2 weeks after discharge + 7 days). The RC will attempt to contact the subject at least three times by phone and one time by email in an attempt to complete the follow-up study visit and will notify PI about the non-availability of the subject to complete it. Responses will be entered into RedCAP by the RC if the survey is conducted by phone.
In order to objective data on whether the inpatient intervention was utilized by families the investigators will request a caregiver tray report from Morrison's food vendor company for the caregiver trays. The report request will include all caregiver trays ordered for West Tower 15, 14, and 12 floors: -Person who placed the order -Patient room number -Number of trays ordered -Time and date trays ordered -Meal ordered
Study staff will periodically run EPIC reports to determine the number of caregiver trays ordered for the study. This report will be used to reimburse social work for the cost of the food trays.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Primary caregiver (parent or legal representative who self-identifies as a primary caregiver) of a child admitted to West Tower acute care floors 12th, 14th and 15th at Texas Childrens Hospital Medical Center Campus. Study procedures will not involve the child directly.
- Age > 18 years old.
- English or Spanish speaking
- Hospital day 3 or greater
Exclusion Criteria:
- Caregiver at bedside is not the primary caregiver of the child as confirmed at time of informed consent.
- Previous enrollment on this study.
- Adolescent and Rehabilitation designated beds on 14th and 12th floors respectively.
- Confirmed COVID-19 positive patients under enhanced respiratory precautions because the caregivers for these patients are receiving food trays provided to them by the unit. (Caregivers of patients who are under investigation for COVID will not be enrolled until after the test is negative.)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of Food Insecurity
Time Frame: Up to 3 weeks
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The primary outcome is prevalence of food insecurity.
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Up to 3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients Enrolled in Food Insecurity
Time Frame: 6 months
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Secondary outcomes are percentage of patients completing Houston Food Bank referral, and the percentage of patients who enroll in one or more food resource.
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michelle Lopez, MD, Baylor College Of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-48108
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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