Facilitating Access to Specialty Treatment
- Conditions
- Concussion, SevereConcussion, IntermediateConcussion, MildMild Traumatic Brain Injury
- Interventions
- Other: RPM-assisted specialist access
- Registration Number
- NCT05741411
- Lead Sponsor
- Children's Hospital of Philadelphia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 210
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Concussed youth at risk for prolonged symptoms RPM-assisted specialist access -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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 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
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
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 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
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
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
Trial Locations
- Locations (1)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States