Social Determinants of HealthLEAPNCT05654220
Linking Emergency Department Patients to Assistance Programs Study
A study testing Text Messaging Intervention in people with Social Determinants of Health, run by University of Pennsylvania at 1 site in United States.
Trial summary
The objective of this randomized controlled trial is to test the effect of screening patients in Penn Medicine Emergency Departments for eligibility of public benefits programs and using text messages post-discharge to connect patients to benefits enrollment specialists at Benefits Data Trust (BDT). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Determinants of Health
- What is being tested?
- Text Messaging Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2023to 30 Jun 2024
- 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
- Patients will be included in the study based on the following criteria:
- Adults at least 18 years of age
- Patients must legally reside in Philadelphia
- Patients receiving care from Penn Medicine Emergency Departments at the Hospital of the University of Pennsylvania and Penn Presbyterian Medical Centerwho are deemed unlikely to require inpatient hospitalization or observation at the time of enrollment
- Patients must have one of the following insurance plans: Medicaid and/or Medicare (managed and traditional).
- Patient must be able to read/write in English.
- Patients must be eligible for at least 1 of the benefits programs for which BDT can provide either direct application assistance or provide a referral to the social services agency website to submit applications.
- Patients have a stable mobile phone number for the next 3 weeks.
Who cannot join
- Patients will be excluded from participating in the study based on the following criteria:
- Individuals < 18 years
- Patients deemed by ED physicians to be in critical or unstable condition
- Does not speak/read English
- Patient is in severe distress, e.g., respiratory, physical, or emotional distress
- Patient is intoxicated, unconscious, or unable to appropriately respond to questions
Show all 10Show fewer
- Patients under police custody
- Patients with a positive COVID-19 test
- Patients with private health insurance benefits or without health insurance
- Patients without a stable mobile phone number for the next 21 days
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Controlled Trial to Link Emergency Department Patients to Navigation Services for Enrollment in Public Benefits
The objective of this randomized controlled trial is to test the effect of screening patients in Penn Medicine Emergency Departments for eligibility of public benefits programs and using text messages post-discharge to connect patients to benefits enrollment specialists at Benefits Data Trust (BDT). Eligible patients will be randomly selected to receive text messages for two weeks after Emergency Department discharge with the phone number to speak with a benefits enrollment specialist at BDT. The number of calls to the BDT phone line and the number of submitted applications to public benefits programs will be compared between patients receiving a summary flyer with the phone number for BDT and the text message intervention to connect with BDT in comparison to an active control group who receives only a summary flyer with the phone number for BDT.
Read the detailed description
Every year, Philadelphians fail to claim approximately $450 million dollars in federal and state benefits1. Across the United States, unclaimed benefits are estimated at approximately $60 billion1. These benefits include support for food, housing, healthcare, economic support, and others that can make a significant impact on well-being, upward mobility, and financial stability. The reasons that benefits are unclaimed are numerous, including lack of awareness about benefit programs and eligibility criteria, lack of agency and self-efficacy in completing expansive application requirements and organizing the necessary paperwork, and navigating the psychological costs of stigma associated with seeking public benefits2. In accordance with incentive structures developed as a result of the Affordable Care Act, health care systems have demonstrated value in screening for patients' social needs and creating partnerships with public service agencies to connect patients to social services to improve individual and population health and reduce health care disparities3-5. Patients presenting to emergency departments are more likely to possess unmet social needs6-8. Thus, it is critical for health care providers in emergency departments to effectively identify patients' social needs and connect patients to social services agencies that can provide both immediate and long-term assistance through the connection to public benefits programs.
Benefits Data Trust (BDT), a benefits support organization based in Philadelphia, has a long track record of success in consistently securing benefits for individuals with unmet social needs. BDT assists individuals with the completion and submission of applications for 19 public benefits programs (e.g., Supplemental Nutrition Assistance Program, the Low-Income Home Energy Assistance Program, and the Pharmaceutical Contract for the Elderly) via different channels, including web, phone, text, and in-person support services. Trained outreach specialists are knowledgeable about the intricacies of benefits applications and eligibility requirements, and support is available in multiple languages. Building trust with clients and serving vulnerable underserved communities is a central focus for outreach specialists. For services that they do not provide assistance for, BDT is also staffed to provide warm handoffs to help connect individuals to relevant organizations.
The focus of this proposal is to test whether patients identified in Penn Medicine Emergency Departments (ED) randomized to receive a warm handoff text messaging intervention are more likely to connect to study-specific BDT phone line and submit more applications for public benefits programs in comparison to patients who only receive a summary flyer with the BDT study-specific phone line upon discharge from the Emergency Department.
We will first conduct a pilot study with 30 participants to assess the design efficacy and implementation success of the text messaging intervention. After which, we will concurrently launch a two-arm prospective intervention randomized controlled trial that is expected to occur over 6 months in Penn Medicine Emergency Departments. The study will use Way To Health, a research information technology platform at the University of Pennsylvania used previously in digital health engagement clinical trials.
We propose to first survey patients to determine their eligibility for public benefits programs. Second, patients who are eligible for at least 1 of the 21 benefits programs to which BDT either provides direct application support or provides referrals to agency websites to complete applications will be randomly selected to either receive a flyer with the study-specific BDT phone number to apply for public benefits programs (active control) or receive a text messaging intervention for two weeks after leaving the ED with instructions to connect to the BDT study-specific phone line in addition to the flyer. Patients randomized to the intervention arm will receive an initial text message one-day post-discharge from the ED with instructions for connecting with BDT and will receive subsequent reminders to connect with BDT on Days 3, 7, and 14 post-discharge. Patients who indicate that they have successfully connected with BDT on Day 3 will not receive intervention messages on Days 7 and 14. All patients, both those randomized to the control and intervention groups, will receive an end-of-study survey on Day 14 post-discharge from the ED to ask patients if they connected with BDT, assess the patient's experience in the research study, and provide a reminder about the number to connect with BDT.
Insights from this randomized controlled trial will inform future work evaluating benefits enrollment outcomes, the relationship between benefits enrollment and health care outcomes, and variations in health services use among patients connected to BDT in the ED.
- Conditions
- Social Determinants of Health
- Being tested
- Text Messaging Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Messaging InterventionBehavioural
A text messaging intervention will be conducted that includes prompts to call trained BenePhilly enrollment specialists to submit applications for benefits programs. Text message prompts will be sent on days 2, 4, 7, 14, and 21 post-discharge from a Penn Medicine emergency department.
| Study group | Role | What they receive |
|---|---|---|
| Active Control | No intervention | Participants in the control group will receive a summary flyer providing contact information for benefits enrollment navigators at BenePhilly, which includes a unique study phone line provided by Benefits Data Trust. Currently, the standard of care is for ED patients to receive no information about public benefits. Therefore, the flyer represents an augmentation of usual care for patients randomized to the control group. |
| Intervention | Experimental | Participants in the intervention arm will receive a summary flyer providing contact information for benefits enrollment navigators at BenePhilly and will be instructed that study personnel will contact them one-day post-discharge to help connect them to a BDT enrollment navigator to help them submit their applications for public benefits. At Day 1 post-discharge, participants in the intervention group will receive a text message to prompt them to call the BDT enrollment navigators to complete their applications for public benefits they screened for while in the ED. On Day 3, patients will receive a follow-up message to assess whether they have contacted BDT. Those participants who indicate they have not yet connected with BDT on Day 3 will receive reminder text messages at Day 7 and 14 post-discharge. Receives: Behavioral: Text Messaging Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Connection to BDT
Participant connection to BDT measured by phone calls completed by confirmed participants to BDT.
Measured: 14 days post-discharge from the emergency department
Secondary outcomes (1)
Number of Applications Submitted
Number of applications for public benefits programs submitted per participant by BDT.
Measured: 14 days post-discharge from the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start19 Jul 2023
- Primary completion15 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social Determinants of HealthStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Benefits Data Trust
- Responsible party
- Sponsor
- Investigators
- Austin Kilaru, MD, MSHP, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654220
- Sponsor's protocol ID
- 852553
- Acronym
- LEAP
- Status last verified
- Jul 2024
- First submitted
- 8 Dec 2022
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kilaru AS, Haider A, Harrison J, Dixon EL, Southwick L, Berkowitz M, Rareshide C, Carroll C, Kaledin C, McDermott G, Mehta M, Stephens Shields AJ, De La Rosa W, Agarwal AK, Merchant RM. Linkage of Emergency Department Patients With Public Benefits Navigators via Text Messages: A Randomized Clinical Trial. JAMA Health Forum. 2026 Feb 6;7(2):e256637. doi: 10.1001/jamahealthforum.2025.6637.
PubMed 41649829
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Link Emergency Department Patients to Navigation Services for Enrollment in Public Benefits
- ClinicalTrials.gov ID
- NCT05654220
- Acronym / sponsor ID
- LEAP / 852553
- Conditions
- Social Determinants of Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Benefits Data Trust
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 16 Dec 2022 (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.
The objective of this randomized controlled trial is to test the effect of screening patients in Penn Medicine Emergency Departments for eligibility of public benefits programs and using text messages post-discharge to connect patients to benefits enrollment specialists at Benefits Data Trust (BDT). Eligible patients will be randomly selected to receive text messages for two weeks after Emergency Department discharge with the phone number to speak with a benefits enrollment specialist at BDT. The number of calls to the BDT phone line and the number of submitted applications to public benefits programs will be compared between patients receiving a summary flyer with the phone number for BDT and the text message intervention to connect with BDT in comparison to an active control group who receives only a summary flyer with the phone number for BDT.
Detailed description
Every year, Philadelphians fail to claim approximately $450 million dollars in federal and state benefits1. Across the United States, unclaimed benefits are estimated at approximately $60 billion1. These benefits include support for food, housing, healthcare, economic support, and others that can make a significant impact on well-being, upward mobility, and financial stability. The reasons that benefits are unclaimed are numerous, including lack of awareness about benefit programs and eligibility criteria, lack of agency and self-efficacy in completing expansive application requirements and organizing the necessary paperwork, and navigating the psychological costs of stigma associated with seeking public benefits2. In accordance with incentive structures developed as a result of the Affordable Care Act, health care systems have demonstrated value in screening for patients' social needs and creating partnerships with public service agencies to connect patients to social services to improve individual and population health and reduce health care disparities3-5. Patients presenting to emergency departments are more likely to possess unmet social needs6-8. Thus, it is critical for health care providers in emergency departments to effectively identify patients' social needs and connect patients to social services agencies that can provide both immediate and long-term assistance through the connection to public benefits programs.
Benefits Data Trust (BDT), a benefits support organization based in Philadelphia, has a long track record of success in consistently securing benefits for individuals with unmet social needs. BDT assists individuals with the completion and submission of applications for 19 public benefits programs (e.g., Supplemental Nutrition Assistance Program, the Low-Income Home Energy Assistance Program, and the Pharmaceutical Contract for the Elderly) via different channels, including web, phone, text, and in-person support services. Trained outreach specialists are knowledgeable about the intricacies of benefits applications and eligibility requirements, and support is available in multiple languages. Building trust with clients and serving vulnerable underserved communities is a central focus for outreach specialists. For services that they do not provide assistance for, BDT is also staffed to provide warm handoffs to help connect individuals to relevant organizations.
The focus of this proposal is to test whether patients identified in Penn Medicine Emergency Departments (ED) randomized to receive a warm handoff text messaging intervention are more likely to connect to study-specific BDT phone line and submit more applications for public benefits programs in comparison to patients who only receive a summary flyer with the BDT study-specific phone line upon discharge from the Emergency Department.
We will first conduct a pilot study with 30 participants to assess the design efficacy and implementation success of the text messaging intervention. After which, we will concurrently launch a two-arm prospective intervention randomized controlled trial that is expected to occur over 6 months in Penn Medicine Emergency Departments. The study will use Way To Health, a research information technology platform at the University of Pennsylvania used previously in digital health engagement clinical trials.
We propose to first survey patients to determine their eligibility for public benefits programs. Second, patients who are eligible for at least 1 of the 21 benefits programs to which BDT either provides direct application support or provides referrals to agency websites to complete applications will be randomly selected to either receive a flyer with the study-specific BDT phone number to apply for public benefits programs (active control) or receive a text messaging intervention for two weeks after leaving the ED with instructions to connect to the BDT study-specific phone line in addition to the flyer. Patients randomized to the intervention arm will receive an initial text message one-day post-discharge from the ED with instructions for connecting with BDT and will receive subsequent reminders to connect with BDT on Days 3, 7, and 14 post-discharge. Patients who indicate that they have successfully connected with BDT on Day 3 will not receive intervention messages on Days 7 and 14. All patients, both those randomized to the control and intervention groups, will receive an end-of-study survey on Day 14 post-discharge from the ED to ask patients if they connected with BDT, assess the patient's experience in the research study, and provide a reminder about the number to connect with BDT.
Insights from this randomized controlled trial will inform future work evaluating benefits enrollment outcomes, the relationship between benefits enrollment and health care outcomes, and variations in health services use among patients connected to BDT in the ED.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Control | No intervention | –Participants in the control group will receive a summary flyer providing contact information for benefits enrollment navigators at BenePhilly, which includes a unique study phone line provided by Benefits Data Trust. Currently, the standard of care is for ED patients to receive no information about public benefits. Therefore, the flyer represents an augmentation of usual care for patients randomized to the control group. |
| Intervention | Experimental | Behavioral: Text Messaging InterventionParticipants in the intervention arm will receive a summary flyer providing contact information for benefits enrollment navigators at BenePhilly and will be instructed that study personnel will contact them one-day post-discharge to help connect them to a BDT enrollment navigator to help them submit their applications for public benefits. At Day 1 post-discharge, participants in the intervention group will receive a text message to prompt them to call the BDT enrollment navigators to complete their applications for public benefits they screened for while in the ED. On Day 3, patients will receive a follow-up message to assess whether they have contacted BDT. Those participants who indicate they have not yet connected with BDT on Day 3 will receive reminder text messages at Day 7 and 14 post-discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults at least 18 years of age
- Patients must legally reside in Philadelphia
- Patients receiving care from Penn Medicine Emergency Departments at the Hospital of the University of Pennsylvania and Penn Presbyterian Medical Centerwho are deemed unlikely to require inpatient hospitalization or observation at the time of enrollment
- Patients must have one of the following insurance plans: Medicaid and/or Medicare (managed and traditional).
- Patient must be able to read/write in English.
Key exclusion criteria (10 listed)
- Patients will be excluded from participating in the study based on the following criteria:
- Individuals < 18 years
- Patients deemed by ED physicians to be in critical or unstable condition
- Does not speak/read English
- Patient is in severe distress, e.g., respiratory, physical, or emotional distress
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 |
|---|---|---|
| Text Messaging InterventionA text messaging intervention will be conducted that includes prompts to call trained BenePhilly enrollment specialists to submit applications for benefits programs. Text message prompts will be sent on days 2, 4, 7, 14, and 21 post-discharge from a Penn Medicine emergency department. | Behavioural | Intervention |
Primary outcome
Participant Connection to BDT
Time frame: 14 days post-discharge from the emergency department
Participant connection to BDT measured by phone calls completed by confirmed participants to BDT.
1 secondary outcome
Number of Applications Submitted
Time frame: 14 days post-discharge from the emergency department
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 31 Jul 2024.
- Derived from this study: PubMed 41649829Kilaru AS, Haider A, Harrison J, Dixon EL, Southwick L, Berkowitz M, Rareshide C, Carroll C, Kaledin C, McDermott G, Mehta M, Stephens Shields AJ, De La Rosa W, Agarwal AK, Merchant RM. Linkage of Emergency Department Patients With Public Benefits Navigators via Text Messages: A Randomized Clinical Trial. JAMA Health Forum. 2026 Feb 6;7(2):e256637. doi: 10.1001/jamahealthforum.2025.6637.
- 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.
Austin Kilaru, MD, MSHP principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messaging Intervention in people with Social Determinants of Health, run by University of Pennsylvania 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 8 inclusion and 10 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 31 Jul 2024. 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?
Participant Connection to BDT (time frame: 14 days post-discharge from the emergency department). 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 NCT05654220, which also lists 1 linked publication.
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 31 Jul 2024.