- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05654220
Linking Emergency Department Patients to Assistance Programs Study (LEAP)
A Randomized Controlled Trial to Link Emergency Department Patients to Navigation Services for Enrollment in Public Benefits
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joseph Harrison, MBDS
- Phone Number: 215-573-6207
- Email: joseph.harrison@pennmedicine.upenn.edu
Study Contact Backup
- Name: Lauren Southwick, MPH
- Email: lauren.southwick@pennmedicine.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania Health System
-
Contact:
- Joseph Harrison, MBDS
- Phone Number: 267-571-6229
- Email: joseph.harrison@pennmedicine.upenn.edu
-
Principal Investigator:
- Austin Kilaru, MD, MSHP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Active Control
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.
|
|
Experimental: Intervention
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
14 days post-discharge from the emergency department
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Applications Submitted
Time Frame: 14 days post-discharge from the emergency department
|
Number of applications for public benefits programs submitted per participant by BDT.
|
14 days post-discharge from the emergency department
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Austin Kilaru, MD, MSHP, Principal Investigator
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 852553
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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