Food Insecurity Screening and Intervention: From Hospital to Home
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|ClinicalTrials.gov Identifier: NCT04739540|
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : April 26, 2021
|Condition or disease|
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 :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Food Insecurity Screening and Intervention: From Hospital to Home|
|Actual Study Start Date :||March 11, 2021|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
- Prevalence of Food Insecurity [ Time Frame: Up to 3 weeks ]The primary outcome is prevalence of food insecurity.
- Percentage of Patients Enrolled in Food Insecurity [ Time Frame: 6 months ]Secondary outcomes are percentage of patients completing Houston Food Bank referral, and the percentage of patients who enroll in one or more food resource.
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): NCT04739540
|Contact: Michelle Lopez, MDemail@example.com|
|United States, Texas|
|Texas Children's Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Michelle Lopez, MD|
|Principal Investigator:||Michelle Lopez, MD||Baylor College of Medicine|