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PovertyNCT03562910

Mobile-based Social Services Screening and Referral Tool in an Pediatric Emergency Department

A study testing HelpSteps application in people with Poverty and Social Determinants of Health, run by Boston Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
HelpSteps application
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
1 siteUnited States
Study dates
13 May 2019to 11 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Boston Children's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Pilot Study of a Novel Mobile-based Social Services Self-screening and Referral Tool in an Urban Pediatric Emergency Department

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.

Read the 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).

Being tested
HelpSteps application
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HelpSteps applicationOther

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

Study groups in NCT03562910
Study groupRoleWhat they receive
InterventionExperimentalAll enrolled subjects will be given access to the HelpSteps application, either via their personal cell phone or to a provided tablet.
Receives: Other: HelpSteps application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of Social Needs

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

    Measured: Day of enrollment

Secondary outcomes (4)
  1. Number of referral agencies selected/contacted

    Participant selection and report of contacting social services organizations

    Measured: Day of enrollment and Two weeks post-enrollment

  2. Improvement in Social Needs

    Participant report of social need improved

    Measured: Two weeks post-enrollment

  3. Impact on clinical flow

    ED physician report of time added to encounter as a result of HelpSteps

    Measured: Day of enrollment

  4. ED physician attitudes towards social screening

    ED physician report on usefulness of HelpSteps

    Measured: Day of enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2018
  2. Study start13 May 2019
  3. Primary completion11 Nov 2020
  4. Study completion11 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03562910
Sponsor's protocol ID
P00026275
Status last verified
Mar 2021
First submitted
1 Feb 2018
Last updated
2 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28302365
  • 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.

    PubMed 17545363
  • 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.

    PubMed 26215831

Questions about this trial

What is this clinical trial studying?

A study testing HelpSteps application in people with Poverty and Social Determinants of Health, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of Social Needs (time frame: Day of enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03562910, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.

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