Clinical trial NCT05741411: Facilitating Access to Specialty Treatment
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Traumatic Brain Injury
Concussion, Mild
Concussion, Severe
Concussion, Intermediate
Keywords: mobile health
emergency department
persistent post-concussion symptoms
remote patient monitoring
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-02-23
Enrollment: 210
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group intervention arm compared to historical controls
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Persisting Post-Concussion Symptoms (PPCS, Primary Effectiveness)
timeFrame: 28 days from injury
measure: Percent of participants meeting referral criteria who interact with a specialty care provider (Fidelity, Primary Implementation)
timeFrame: 28 days from injury
Secondary outcomes:
measure: Modeling of PPCS (Secondary Effectiveness)
timeFrame: 28 days from injury
measure: Days until return to symptoms baseline (Secondary Effectiveness)
timeFrame: Up to 90 days from injury
measure: Days until clearance (Secondary Effectiveness)
timeFrame: Up to 90 days from injury
measure: Days until return to school (Secondary Effectiveness)
timeFrame: Up to 90 days from injury
measure: Modeling of fidelity (Secondary Implementation)
timeFrame: 28 days from injury
measure: Patient-defined quantitative appropriateness (Secondary Implementation)
timeFrame: Within 1 year of completing study procedures
measure: Patient-defined qualitative appropriateness (Secondary Implementation)
timeFrame: Within 1 year of completing study procedures
measure: Provider-defined qualitative acceptability (Secondary Implementation)
timeFrame: Within 1 year of completing study procedures
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Daniel J Corwin, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zemek R, Barrowman N, Freedman SB, Gravel J, Gagnon I, McGahern C, Aglipay M, Sangha G, Boutis K, Beer D, Craig W, Burns E, Farion KJ, Mikrogianakis A, Barlow K, Dubrovsky AS, Meeuwisse W, Gioia G, Meehan WP 3rd, Beauchamp MH, Kamil Y, Grool AM, Hoshizaki B, Anderson P, Brooks BL, Yeates KO, Vassilyadi M, Klassen T, Keightley M, Richer L, DeMatteo C, Osmond MH; Pediatric Emergency Research Canada (PERC) Concussion Team. Clinical Risk Score for Persistent Postconcussion Symptoms Among Children With Acute Concussion in the ED. JAMA. 2016 Mar 8;315(10):1014-25. doi: 10.1001/jama.2016.1203.
citation: Corwin DJ, Arbogast KB, Haber RA, Pettijohn KW, Zonfrillo MR, Grady MF, Master CL. Characteristics and Outcomes for Delayed Diagnosis of Concussion in Pediatric Patients Presenting to the Emergency Department. J Emerg Med. 2020 Dec;59(6):795-804. doi: 10.1016/j.jemermed.2020.09.017. Epub 2020 Oct 7.
citation: Master CL, Master SR, Wiebe DJ, Storey EP, Lockyer JE, Podolak OE, Grady MF. Vision and Vestibular System Dysfunction Predicts Prolonged Concussion Recovery in Children. Clin J Sport Med. 2018 Mar;28(2):139-145. doi: 10.1097/JSM.0000000000000507.
citation: Desai N, Wiebe DJ, Corwin DJ, Lockyer JE, Grady MF, Master CL. Factors Affecting Recovery Trajectories in Pediatric Female Concussion. Clin J Sport Med. 2019 Sep;29(5):361-367. doi: 10.1097/JSM.0000000000000646.
citation: Wiebe DJ, Nance ML, Houseknecht E, Grady MF, Otto N, Sandsmark DK, Master CL. Ecologic Momentary Assessment to Accomplish Real-Time Capture of Symptom Progression and the Physical and Cognitive Activities of Patients Daily Following Concussion. JAMA Pediatr. 2016 Nov 1;170(11):1108-1110. doi: 10.1001/jamapediatrics.2016.1979. No abstract available.
citation: Corwin DJ, Orchinik J, D'Alonzo B, Agarwal AK, Pettijohn KW, Master CL, Wiebe DJ. A Randomized Trial of Incentivization to Maximize Retention for Real-Time Symptom and Activity Monitoring Using Ecological Momentary Assessment in Pediatric Concussion. Pediatr Emerg Care. 2023 Jul 1;39(7):488-494. doi: 10.1097/PEC.0000000000002870. Epub 2022 Nov 3.