- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03656146
Food for Thought: Food Insecurity Screening in the Emergency Department
Food for Thought: A Randomized Trial of Food Insecurity Screening in the Emergency Department
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Children are disproportionately affected by the rise in poverty rates in the United States, and economic hardships can compromise their development, negatively affect their overall health, and adversely affect their abilities to succeed in school and in life. Food insecurity (FI)-the limited or uncertain availability of nutritionally adequate or safe foods- while strongly associated with poverty, is an independent predictor of poor health outcomes for children.
The Emergency Department (ED) of academic medical centers often serves as a point of care entry for impoverished and high-risk families. Although there is a growing interest in the healthcare system's ability to address Social Determinants of Health (SDH), little is known about food insecurity in the pediatric ED. Additionally, there are limited data on how to implement FI screening into practice in a way that maximizes elicitation of social need, while assuring patient and family comfort.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- English speaking
- Adult caregiver accompanying pediatric patient in the Children's Hospital of Philadelphia (CHOP) emergency department
Exclusion Criteria:
- Patient (child) in critical condition
- Patient (child) >18 years of age
- Previously enrolled in study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Tablet Screening
Food insecurity screening conducted via electronic tablet
|
The intervention is the type of screening modality used to identify food insecurity: verbal face-to-face, or tablet-based screening
|
|
Active Comparator: Verbal Screening
Food insecurity screening conducted via verbal face-to-face interview
|
The intervention is the type of screening modality used to identify food insecurity: verbal face-to-face, or tablet-based screening
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of Food Insecurity
Time Frame: 12 months
|
Affirmative response to either of the two, validated screening questions for food insecurity.
Investigators measured food insecurity using the validated two-question "Hunger Vital Sign" screening tool, with yes/no responses.
These two questions are: within the past 12 months "we worried whether our food would run out before we got money to buy more" and "the food we bought just didn't last and we didn't have money to get more."
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preferred Screening Modality
Time Frame: 4 weeks
|
Report of screening modality preference: verbal, tablet, or no preference
|
4 weeks
|
|
Comfort level with screening location
Time Frame: 4 weeks
|
Report of comfort with screening in the emergency department and in the primary care setting
|
4 weeks
|
Collaborators and Investigators
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-013696
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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