- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05251311
A Mixed-Method Evaluation of the Impact of Social Risk Screening on Uptake of Social Assistance
November 25, 2024 updated by: Children's Hospital of Philadelphia
Children are disproportionately affected by the rise in poverty rates in the United States.
Economic hardships can compromise child development, overall health, and the ability to succeed in school and in life.
The current economic recession and racial disparities underscored by COVID19 have magnified this impact on children and hastened the already rapid growth of screening protocols for social risk factors- such as food and housing insecurity, financial strain, and unsafe environments-within pediatric health care.
However, it remains unclear what effect standardized screening has on family perception of and engagement with resources.
Current implementation momentum for screening protocols is outpacing research, and is raising concern among patient advocates for unintended harm-alienating families for fear of stigma or worse, and overpromising services that may not exist.
Through a rigorous mixed-method approach, the proposed study will explore the impact of screening on acceptance, perception, and engagement with social resources among families with children.
Furthermore, by leveraging the new technology of resource mapping as the method of resource referral, this study will provide insight regarding its effectiveness as a social needs assistance strategy.
The knowledge gained will provide guidance for policymakers and other healthcare systems on how to integrate social risk interventions into healthcare delivery in order to maximize the benefit to children and families.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3949
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19146
- Children's Hospital of Philadelphia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Caregivers presenting with a child to the pediatric clinical setting
- Child age 0-25
Exclusion Criteria:
- Engaged in complex care management services
- Child in critical condition
- Presenting to clinical setting specifically for social work intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Social Risk Screening + Resource Map
Participants randomized to the experimental arm will receive a social risk assessment tool followed by an electronic resource map
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Investigators will use an adapted version of the evidence-based WE CARE screening tool, which assesses need in the 5 domains most frequently requested by our patient population: housing, transportation, child care, food security, and household heat and electricity.
This tool was selected as it is evidence-based, takes fewer than 5 minutes to complete, is written at a 3rd grade reading level, and allows for differentiation between social risk and caregiver desire for assistance, as well as areas of "emergency" need.
All participants will receive access to an electronic, geographically searchable resource map hosted on Aunt Bertha
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Active Comparator: Resource Map
Participants randomized to the active comparator group will receive only an electronic resource map
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All participants will receive access to an electronic, geographically searchable resource map hosted on Aunt Bertha
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Experimental: Resource Menu + Resource Map
Participants randomized to this experimental arm will receive a social resource menu tool followed by an electronic resource map.
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Participants randomized to this experimental arm will receive a social resource menu tool, which assess desire for social resources.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resource Uptake By Search
Time Frame: 30 days
|
total number of searches
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30 days
|
|
Resource Uptake By Domain
Time Frame: 30 days
|
number of searches by domain
|
30 days
|
|
Resource Engagement By Time
Time Frame: 30 days
|
time spent on site
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30 days
|
|
Resource Engagement By Saves
Time Frame: 30 days
|
number of resources saved
|
30 days
|
|
Resource Engagement By Domain
Time Frame: 30 days
|
number of resources saved by domain
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30 days
|
|
Resource Utilization
Time Frame: 30 days
|
rates of resource utilization
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30 days
|
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Resource Impact
Time Frame: 30 days
|
perceived impact of resource use on social need measured by using a modified version of the WE CARE screening tool
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30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived impact of screening on resource acceptance
Time Frame: up to 45 days
|
Qualitative semi-structured interviews
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up to 45 days
|
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Perceived impact of screening on resource perception
Time Frame: up to 45 days
|
Qualitative semi-structured interviews
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up to 45 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Danielle Cullen, MD MPH MSHP, Children's Hospital of Philadelphia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 19, 2022
Primary Completion (Actual)
September 22, 2023
Study Completion (Actual)
September 22, 2023
Study Registration Dates
First Submitted
September 30, 2021
First Submitted That Met QC Criteria
February 10, 2022
First Posted (Actual)
February 22, 2022
Study Record Updates
Last Update Posted (Estimated)
November 27, 2024
Last Update Submitted That Met QC Criteria
November 25, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 21-018785
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.