RecruitingNot Applicable

Facilitating Access to Specialty Treatment

United States210 participantsStarted 2024-03-11

Plain-language summary

The goal of this hybrid implementation-effectiveness study is to evaluate the effectiveness (hastened recovery times) and feasibility (fidelity in connecting to concussion specialty care) of a novel mobile health intervention, designed to reduce disparities in access to specialty care through the use of remote patient monitoring (RPM) to facilitate care hand-off from the emergency department (ED) to concussion specialty care. Participants will report their symptoms and activity once daily through RPM chat technology that is linked to their electronic health record and prompts referral to specialty care.

Who can participate

Age range

13 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for concussed subjects: * Males and females age 13 - 18 * Present to the Children's Hospital of Philadelphia (CHOP) Emergency Department (ED) within 72 hours of head injury * Meet criteria for concussion as defined by the most recent International Consensus Statement on Concussion * Own a smartphone * Meet criteria for moderate-to-high risk for Persistent Post-Concussion Symptoms according to 5P rule (score \>3/12) Exclusion Criteria for concussed subjects: * Glasgow Coma Scale score \<13 * Lower extremity trauma * A prior concussion within 1 month * Non-English speaking * Admission to the hospital at the initial head injury visit * Previously enrolled in the study * Inability to complete study procedures. Inclusion Criteria for parents: * Child meets the study eligibility criteria Exclusion Criteria for parents: * Non-English speaking Inclusion Criteria for providers: * ED or specialty provider caring for at least one patient via the mobile Health (mHealth)-facilitated care handoff strategy Exclusion Criteria for providers: * Non-English speaking

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Persisting Post-Concussion Symptoms (PPCS, Primary Effectiveness)

Timeframe: 28 days from injury

Percent of participants meeting referral criteria who interact with a specialty care provider (Fidelity, Primary Implementation)

Timeframe: 28 days from injury

Trial details

NCT IDNCT05741411

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-31

Contact for this trial

Melissa Godfrey

267-425-0386 godfreym2@chop.edu

View on ClinicalTrials.gov More Mild Traumatic Brain Injury trials