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Clinical Trials/NCT05741411
NCT05741411
Recruiting
N/A

Utilizing Mobile Health to Expedite Access to Specialty Care for Youth Presenting to the Emergency Department With Concussion at Highest Risk of Developing Persisting Symptoms

Children's Hospital of Philadelphia1 site in 1 country210 target enrollmentMarch 11, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mild Traumatic Brain Injury
Sponsor
Children's Hospital of Philadelphia
Enrollment
210
Locations
1
Primary Endpoint
Incidence of Persisting Post-Concussion Symptoms (PPCS, Primary Effectiveness)
Status
Recruiting
Last Updated
10 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 11, 2024
End Date
March 2027
Last Updated
10 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 28 days from injury

Persistence of at least 3 concussion-like symptoms above the pre-injury state beyond 28 days from injury, defined as a positive difference between patient-reported symptoms and the perceived pre-injury symptom rating

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

Time Frame: 28 days from injury

Among those participants who flag to see a specialist, at least 1 interaction with a specialty provider either in person or via telehealth during the acute study period

Secondary Outcomes

  • Days until clearance (Secondary Effectiveness)(Up to 90 days from injury)
  • Modeling of fidelity (Secondary Implementation)(28 days from injury)
  • Patient-defined qualitative appropriateness (Secondary Implementation)(Within 1 year of completing study procedures)
  • Days until return to symptoms baseline (Secondary Effectiveness)(Up to 90 days from injury)
  • Modeling of PPCS (Secondary Effectiveness)(28 days from injury)
  • Days until return to school (Secondary Effectiveness)(Up to 90 days from injury)
  • Patient-defined quantitative appropriateness (Secondary Implementation)(Within 1 year of completing study procedures)
  • Provider-defined qualitative acceptability (Secondary Implementation)(Within 1 year of completing study procedures)

Study Sites (1)

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