Facilitating Access to Specialty Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorChildren's Hospital of Philadelphia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Glasgow Coma Scale score <13
Lower extremity trauma
A prior concussion within 1 month
Non-English speaking
Trial design
Design model
Single group
Treatments tested in this trial
RPM-assisted specialist access
Other interventionParticipants 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.
Treatment groups
210 Participants
are divided into 1 treatment groupGroup A: Concussed youth at risk for prolonged symptomsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Persisting Post-Concussion Symptoms (PPCS, Primary Effectiveness)
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
Time frame
28 days from injury2
Percent of participants meeting referral criteria who interact with a specialty care provider (Fidelity, Primary Implementation)
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
Time frame
28 days from injurySecondary outcomes
1
Modeling of PPCS (Secondary Effectiveness)
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
Time frame
28 days from injury2
Days until return to symptoms baseline (Secondary Effectiveness)
Number of days from injury whereby patient-reported symptoms meets pre-injury baseline levels
Time frame
Up to 90 days from injury3
Days until clearance (Secondary Effectiveness)
Number of days from injury until patient is fully cleared for full activity by a medical provider
Time frame
Up to 90 days from injury4
Days until return to school (Secondary Effectiveness)
Number of days from injury until patient is able to return to full time school without accommodations
Time frame
Up to 90 days from injurySponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Philadelphia
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov