- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03562910
Mobile-based Social Services Screening and Referral Tool in an Pediatric Emergency Department
Pilot Study of a Novel Mobile-based Social Services Self-screening and Referral Tool in an Urban Pediatric Emergency Department
Study Overview
Status
Intervention / Treatment
Detailed Description
Many families presenting in the ED may have unmet social needs. Prior studies have shown that families are receptive to screening for these needs in the ED setting. HelpSteps is a screening tool that not only identifies social needs but also connects individuals with local health and social services agencies. There have been no studies to date assessing the use of a new mobile-version of HelpSteps or the use of the tool in the ED setting. The objective of this study is (1) to assess the feasibility of using a patient-centered social services screening and referral mobile tool in the ED and (2) to determine if the tool is useful in helping patients identify social needs and link to appropriate referral services post-ED visit.
Data will be collected in a prospective, non-randomized fashion using a convenience sample of 330 adult subjects. All parents will be screened for enrollment. If a parent is not present, all unaccompanied patients 18 and older will be screened instead. If there are both parents present, investigators will ask families to self-identify the most appropriate research subject by asking which parent in their family is typically responsible for household resources or applications. Non-English speaking families and patients who present with a triage score of 1 or 2 (high acuity) will be excluded.
Once enrolled, research subjects will be offered the option to either download HelpSteps on a personal cell phone or to use the application on a provided tablet. The subject will then open the Help Steps tool and complete a brief social needs screening survey. Based on the results of the screening and on geographic proximity, HelpSteps will recommend referral agencies personalized to the subject. The subject will then choose agencies they are interested in and receive a personalized list of referrals.
While still in the ED, families will be asked to complete a brief survey regarding ease of use and recommending the tool to family and friends. After the ED visit, subjects will be sent two electronic reminders asking if they would like a referral list resent. All participants will receive a follow-up phone call approximately 2 weeks post-study enrollment to ask whether they have used HelpSteps at home, whether or not they contacted a referral agency, if their social need(s) were resolved, and if the application was helpful in finding a solution to their need(s). The investigators will also ask physicians to fill out a brief survey about the impact of the tool on clinical flow and usefulness in help supplementing care for the patient.
The investigators plan to use descriptive statistics to evaluate three categories of data: (1) social services needs, referrals and follow-up, (2) usefulness of the HelpSteps application, and (3) physician perspectives on use of the HelpSteps in the ED. The investigators will analyze the mobile-based group and the tablet-based group separately as they are likely two different populations (based on the lower socioeconomic status and thus higher social needs associated with not having a phone).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All parents/caregivers or patients 18 and older presenting to a pediatric emergency department
Exclusion Criteria:
- Non-English speaking
- Parents/caregivers or patients Families whose children are triaged to high acuity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
All enrolled subjects will be given access to the HelpSteps application, either via their personal cell phone or to a provided tablet.
|
Mobile or tablet-based tool that screens for social needs and refers to local agency based on needs and proximity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of Social Needs
Time Frame: Day of enrollment
|
Number of social needs categories screened positive for or selected as a need
|
Day of enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of referral agencies selected/contacted
Time Frame: Day of enrollment and Two weeks post-enrollment
|
Participant selection and report of contacting social services organizations
|
Day of enrollment and Two weeks post-enrollment
|
|
Improvement in Social Needs
Time Frame: Two weeks post-enrollment
|
Participant report of social need improved
|
Two weeks post-enrollment
|
|
Impact on clinical flow
Time Frame: Day of enrollment
|
ED physician report of time added to encounter as a result of HelpSteps
|
Day of enrollment
|
|
ED physician attitudes towards social screening
Time Frame: Day of enrollment
|
ED physician report on usefulness of HelpSteps
|
Day of enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Amanda Stewart, MD, MPH, Boston Children's Hospital
Publications and helpful links
General Publications
- Fleegler EW, Lieu TA, Wise PH, Muret-Wagstaff S. Families' health-related social problems and missed referral opportunities. Pediatrics. 2007 Jun;119(6):e1332-41. doi: 10.1542/peds.2006-1505.
- Bottino CJ, Rhodes ET, Kreatsoulas C, Cox JE, Fleegler EW. Food Insecurity Screening in Pediatric Primary Care: Can Offering Referrals Help Identify Families in Need? Acad Pediatr. 2017 Jul;17(5):497-503. doi: 10.1016/j.acap.2016.10.006. Epub 2017 Mar 13.
- Hassan A, Scherer EA, Pikcilingis A, Krull E, McNickles L, Marmon G, Woods ER, Fleegler EW. Improving Social Determinants of Health: Effectiveness of a Web-Based Intervention. Am J Prev Med. 2015 Dec;49(6):822-31. doi: 10.1016/j.amepre.2015.04.023. Epub 2015 Jul 26.
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
- P00026275
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
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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