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NCT Number: NCT05741411

Facilitating Access to Specialty Treatment

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.

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Key information

Conditions

Mild Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Concussion, Intermediate Concussion, Mild Concussion, Severe Craniocerebral Trauma Disease Attributes Emergencies Head Injuries, Closed Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Daniel Corwin, MD,MSCE

CONTACT

[email protected]

215-327-2306

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RPM-assisted specialist access

Other

Participants will be prompted to report current symptoms and activity once a day via remote patient monitoring chat technology for up to 28 days following injury. Patients with either escalating or plateauing symptoms will be flagged, with an electronic alert sent via the electronic health record to a nurse navigator. The nurse navigator will have access to the symptom data and facilitate scheduling an in person or telehealth specialist visit as indicated. Symptoms will continue to be monitored through the 28-day acute study period with additional clinical visits occurring according to clinical need.

Primary outcomes

  1. 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

  2. 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

  1. Modeling of PPCS (Secondary Effectiveness)

    Time frame: 28 days from injury

    Multivariate logistic regression evaluating the effect on the incidence of PPCS of socio-demographic and neighborhood-level economic variables, including race, ethnicity, sex, insurance, mechanism of injury, and child opportunity index, as well as known factors associated with PPCS, including age, concussion history, and co-morbid conditions

  2. Days until return to symptoms baseline (Secondary Effectiveness)

    Time frame: Up to 90 days from injury

    Number of days from injury whereby patient-reported symptoms meets pre-injury baseline levels

  3. Days until clearance (Secondary Effectiveness)

    Time frame: Up to 90 days from injury

    Number of days from injury until patient is fully cleared for full activity by a medical provider

  4. Days until return to school (Secondary Effectiveness)

    Time frame: Up to 90 days from injury

    Number of days from injury until patient is able to return to full time school without accommodations

  5. Modeling of fidelity (Secondary Implementation)

    Time frame: 28 days from injury

    Multivariate logistic regression evaluating the effect on fidelity of socio-demographic and neighborhood-level economic variables, including race, ethnicity, sex, insurance, mechanism of injury, and child opportunity index

  6. Patient-defined quantitative appropriateness (Secondary Implementation)

    Time frame: Within 1 year of completing study procedures

    Mean System Usability Score out of 100 with >=70 defined as acceptable appropriateness

  7. Patient-defined qualitative appropriateness (Secondary Implementation)

    Time frame: Within 1 year of completing study procedures

    Themes from semi-structured interviews with patients related to intervention appropriateness will be identified

  8. Provider-defined qualitative acceptability (Secondary Implementation)

    Time frame: Within 1 year of completing study procedures

    Themes from semi-structured interviews with providers related to intervention acceptability will be identified

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa Godfrey

CONTACT

[email protected]

267-425-0386

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 23, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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