NCT03562910

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

May 13, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
Last Updated

March 2, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

February 1, 2018

Last Update Submit

March 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Social Needs

    Number of social needs categories screened positive for or selected as a need

    Day of enrollment

Secondary Outcomes (4)

  • Number of referral agencies selected/contacted

    Day of enrollment and Two weeks post-enrollment

  • Improvement in Social Needs

    Two weeks post-enrollment

  • Impact on clinical flow

    Day of enrollment

  • ED physician attitudes towards social screening

    Day of enrollment

Study Arms (1)

Intervention

EXPERIMENTAL

All enrolled subjects will be given access to the HelpSteps application, either via their personal cell phone or to a provided tablet.

Other: HelpSteps application

Interventions

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All parents/caregivers or patients 18 and older presenting to a pediatric emergency department

You may not qualify if:

  • Non-English speaking
  • Parents/caregivers or patients Families whose children are triaged to high acuity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related 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.

    PMID: 28302365BACKGROUND
  • 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.

    PMID: 17545363BACKGROUND
  • 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.

    PMID: 26215831BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaEmergencies

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amanda Stewart, MD, MPH

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor of Pediatrics and Emergency Medicine

Study Record Dates

First Submitted

February 1, 2018

First Posted

June 20, 2018

Study Start

May 13, 2019

Primary Completion

November 11, 2020

Study Completion

December 11, 2020

Last Updated

March 2, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations