Concussion mHealth ED to Specialist

Study Overview
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Brief Summary
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The goal of this implementation-based clinical trial is to assess the feasibility of a mobile health (mHealth) tool to facilitate specialist access and care handoffs for 12-17 year old pediatric concussion patients presenting to the emergency department with moderate-to-high risk of developing persistent post-concussion symptoms (PPCS). Participants will report their symptoms twice daily through a digital health platform that is linked to their electronic health record and prompts referral to specialty care when indicated.

Detailed Description
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Patients will be evaluated using the 5P rule. Those scoring 4 or higher (moderate to high risk for persistent post-concussion symptoms) will be enrolled. A digital health platform will prompt subjects to report their current symptoms twice daily throughout the acute study period (28 days following injury). A nurse navigator will have access to the symptom data and will facilitate scheduling of in-person or telehealth visits with a concussion specialist within 10 days of injury and then as needed throughout the recovery period. Semi-structured interviews will be conducted with patient/parent dyads as well as providers to assess their perception of the appropriateness and acceptability of the intervention as well as facilitators and barriers to the mHealth-facilitated referral model. The intervention is designed to reduce barriers to specialist access and improve care continuity and health system navigation.

Official Title
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Mobile Health-Facilitated Specialist Management to Improve Outcomes in Pediatric Concussion Patients

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

Intervention / Treatment
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* Other: mHealth assisted specialist access


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for concussed subjects: Present to the Children's Hospital of Philadelphia (CHOP) Emergency Department within 72 hours of head injury Meet criteria for concussion as defined by the 5th 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 (digital monitoring platform English-language only) 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 mHealth-facilitated care handoff strategy Exclusion Criteria for providers: Non-English speaking

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concussed youth at risk for prolonged symptoms<br> | Other: mHealth assisted specialist access<br>* Concussed subjects will be prompted to report current symptoms twice a day via a digital health platform. A nurse navigator will have access to the symptom data and will facilitate scheduling an in person or telehealth specialist visit as indicated by the symptom data. Symptoms will continue to be monitored through the acute study period with additional clinical visits occurring according to clinical need.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants demonstrating fidelity to the intervention | At least 1 interaction with a specialty provider either in person or via telehealth during the acute study period | 28 days from injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and provider-defined appropriateness of the intervention | Mean System Usability Score out of 100 with >=70 defined as acceptable appropriateness | Within 1 year of completing study procedures | 
| Patient and provider-defined acceptability of the intervention obtained using a Technology Assistance Model framework |  | Within 1 year of completing study procedures | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile health, emergency department, persistent post-concussion symptoms, ecological momentary assessment