Facilitating Access to Specialty Treatment

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

Conditions: Concussion, Severe; Concussion, Intermediate; Mild Traumatic Brain Injury; Concussion, Mild

Treatments: Other: RPM-assisted specialist access

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05741411

K23NS128275 (U.S. NIH Grant/Contract)

22-019755

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

210 participants in 1 patient group

Concussed youth at risk for prolonged symptoms

Experimental group

Treatment:

Other: RPM-assisted specialist access