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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03562910
Other study ID # P00026275
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 13, 2019
Est. completion date December 11, 2020

Study information

Verified date March 2021
Source Boston Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will determine the feasibility and effectiveness of using a mobile-based social services screening and referral tool in an urban pediatric Emergency Department (ED). Families will be offered the option to either download the tool, known as HelpSteps, as a mobile application ("app") on a personal cell phone or to use the app on a provided tablet. After leading the family through a brief social needs screening survey, HelpSteps will recommend local social service agencies based on identified needs and location. Families will then complete a brief survey on the ease of use of the tool as well as receive a follow-up call to ask about usefulness of the tool in solving social problems. The investigators will also ask physicians to fill out a brief survey about the use of the tool in the ED.


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).


Recruitment information / eligibility

Status Completed
Enrollment 266
Est. completion date December 11, 2020
Est. primary completion date November 11, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
HelpSteps application
Mobile or tablet-based tool that screens for social needs and refers to local agency based on needs and proximity.

Locations

Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Boston Children's Hospital Verizon Foundation

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of Social Needs Number of social needs categories screened positive for or selected as a need Day of enrollment
Secondary Number of referral agencies selected/contacted Participant selection and report of contacting social services organizations Day of enrollment and Two weeks post-enrollment
Secondary Improvement in Social Needs Participant report of social need improved Two weeks post-enrollment
Secondary Impact on clinical flow ED physician report of time added to encounter as a result of HelpSteps Day of enrollment
Secondary ED physician attitudes towards social screening ED physician report on usefulness of HelpSteps Day of enrollment
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