Facilitating Access to Specialty Treatment

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

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 Overview

• Status: Recruiting
• Conditions: Mild Traumatic Brain Injury; Concussion, Mild; Concussion, Severe; Concussion, Intermediate
• Intervention / Treatment: Other: RPM-assisted specialist access

Detailed Description

Patients will be evaluated using the 5P rule. Those scoring 4 or higher (moderate to high risk for persistent post-concussion symptoms) and meeting all other eligibility criteria will be enrolled. A remote patient monitoring chat platform will prompt subjects to report their current symptoms and activity once daily throughout the acute study period (up to 28 days following injury). A nurse navigator will have access to the symptom data within the electronic health record and will facilitate scheduling of in-person or telehealth visits with a concussion specialist as needed throughout the recovery period. Semi-structured interviews will be conducted with patient/parent dyads as well as providers to assess their perception of the appropriateness and acceptability of the intervention as well as facilitators and barriers to the mHealth-facilitated referral model. The intervention is designed to reduce barriers to specialist access and improve care continuity and health system navigation.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa Godfrey; Phone Number: 267-425-0386; Email: godfreym2@chop.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
      • Contact: Daniel Corwin, MD,MSCE; Phone Number: 215-327-2306; Email: corwind@chop.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Concussed youth at risk for prolonged symptoms

Other: RPM-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	28 days from injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	28 days from injury
Patient-defined quantitative appropriateness (Secondary Implementation)	Mean System Usability Score out of 100 with >=70 defined as acceptable appropriateness	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	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	Within 1 year of completing study procedures

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Persistent Post-Concussion Symptoms (PPCS)	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	28 days from injury

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Daniel J Corwin, MD, MSCE, Children's Hospital of Philadelphia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Corwin DJ, Godfrey M, Arbogast KB, Zorc JJ, Wiebe DJ, Michel JJ, Barnett I, Stenger KM, Calandra LM, Cobb J, Winston FK, Master CL. Using mobile health to expedite access to specialty care for youth presenting to the emergency department with concussion at highest risk of developing persisting symptoms: a protocol paper for a non-randomised hybrid implementation-effectiveness trial. BMJ Open. 2024 Jun 19;14(6):e082644. doi: 10.1136/bmjopen-2023-082644.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: mobile health; emergency department; remote patient monitoring; persistent post-concussion symptoms
• Additional Relevant MeSH Terms: Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Disease Attributes; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Pathological Conditions, Signs and Symptoms; Emergencies; Brain Concussion
• Other Study ID Numbers: 22-019755; K23NS128275 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No