Concussion, Intermediate, Concussion, Mild, Concussion, Severe, Mild Traumatic Brain Injury
Conditions
Keywords
mobile health, emergency department, persistent post-concussion symptoms, remote patient monitoring
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.
Interventions
OTHERRPM-assisted specialist access
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.
Sponsors
Children's Hospital of Philadelphia
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single group intervention arm compared to historical controls
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Persisting Post-Concussion Symptoms (PPCS, Primary Effectiveness) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Modeling of PPCS (Secondary Effectiveness) | 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 |
| Days until return to symptoms baseline (Secondary Effectiveness) | Up to 90 days from injury | Number of days from injury whereby patient-reported symptoms meets pre-injury baseline levels |
| Days until clearance (Secondary Effectiveness) | Up to 90 days from injury | Number of days from injury until patient is fully cleared for full activity by a medical provider |
| Days until return to school (Secondary Effectiveness) | Up to 90 days from injury | Number of days from injury until patient is able to return to full time school without accommodations |
| Modeling of fidelity (Secondary Implementation) | 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 |
| Patient-defined quantitative appropriateness (Secondary Implementation) | Within 1 year of completing study procedures | Mean System Usability Score out of 100 with \>=70 defined as acceptable appropriateness |
| Patient-defined qualitative appropriateness (Secondary Implementation) | Within 1 year of completing study procedures | Themes from semi-structured interviews with patients related to intervention appropriateness will be identified |
| Provider-defined qualitative acceptability (Secondary Implementation) | Within 1 year of completing study procedures | Themes from semi-structured interviews with providers related to intervention acceptability will be identified |
Countries
United States
Contacts
CONTACTMelissa Godfrey
PRINCIPAL_INVESTIGATORDaniel J Corwin, MD, MSCE
Children's Hospital of Philadelphia
Outcome results
None listed