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.
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
- Conditions the study is for
- Poverty, Social Determinants of Health, Mobile Applications
- 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
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All 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.
Prevalence of Social Needs
Number of social needs categories screened positive for or selected as a need
Measured: Day of enrollment
Secondary outcomes (4)
Number of referral agencies selected/contacted
Participant selection and report of contacting social services organizations
Measured: Day of enrollment and Two weeks post-enrollment
Improvement in Social Needs
Participant report of social need improved
Measured: Two weeks post-enrollment
Impact on clinical flow
ED physician report of time added to encounter as a result of HelpSteps
Measured: Day of enrollment
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.
- First posted20 Jun 2018
- Study start13 May 2019
- Primary completion11 Nov 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PovertyStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Verizon Foundation
- Responsible party
- Principal investigator, Amanda Stewart, Boston Children's Hospital
- Investigators
- Amanda Stewart, MD, MPH, Principal investigator, Boston Children's Hospital
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 28302365Fleegler 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 17545363Hassan 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Novel Mobile-based Social Services Self-screening and Referral Tool in an Urban Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT03562910
- Acronym / sponsor ID
- P00026275
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Verizon Foundation
- Study start
- 13 May 2019 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: HelpSteps applicationAll enrolled subjects will be given access to the HelpSteps application, either via their personal cell phone or to a provided tablet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All parents/caregivers or patients 18 and older presenting to a pediatric emergency department
Key exclusion criteria (2 listed)
- Non-English speaking
- Parents/caregivers or patients Families whose children are triaged to high acuity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HelpSteps applicationMobile or tablet-based tool that screens for social needs and refers to local agency based on needs and proximity. | Other | Intervention |
Primary outcome
Prevalence of Social Needs
Time frame: Day of enrollment
Number of social needs categories screened positive for or selected as a need
4 secondary outcomes
Number of referral agencies selected/contacted
Time frame: Day of enrollment and Two weeks post-enrollment
Improvement in Social Needs
Time frame: Two weeks post-enrollment
Impact on clinical flow
Time frame: Day of enrollment
ED physician attitudes towards social screening
Time frame: Day of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Background: PubMed 28302365Bottino 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.
- Background: PubMed 17545363Fleegler 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.
- Background: PubMed 26215831Hassan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Stewart, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
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.