Facilitating Access to Specialty Treatment

Children's Hospital of Philadelphia210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

210

Conditions

Mild Traumatic Brain Injury Concussion, Mild Concussion, Severe Concussion, Intermediate

Eligibility

Sex: ALLMin age: 13 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 injury

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 injury

Secondary Outcomes

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 injury

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 injury

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 injury

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 injury

Modeling of fidelity (Secondary Implementation)

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

Time frame: 28 days from injury

Patient-defined quantitative appropriateness (Secondary Implementation)

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

Time frame: Within 1 year of completing study procedures

Patient-defined qualitative appropriateness (Secondary Implementation)

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

Time frame: Within 1 year of completing study procedures

Provider-defined qualitative acceptability (Secondary Implementation)

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

Time frame: Within 1 year of completing study procedures

Facilitating Access to Specialty Treatment

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts