Facilitating Access to Specialty Treatment

NCT05741411 | Recruiting

• 2 other identifiers: 22-019755K23NS128275
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

mobile health; emergency department; persistent post-concussion symptoms; remote patient monitoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Modeling of PPCS (Secondary Effectiveness)

  28 days from injury

• Days until return to symptoms baseline (Secondary Effectiveness)

  Up to 90 days from injury

• Days until clearance (Secondary Effectiveness)

  Up to 90 days from injury

• Days until return to school (Secondary Effectiveness)

  Up to 90 days from injury

• Modeling of fidelity (Secondary Implementation)

  28 days from injury

Study Arms (1)

Concussed youth at risk for prolonged symptoms

EXPERIMENTAL

Other: RPM-assisted specialist access

Interventions

RPM-assisted specialist access OTHER

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.

Concussed youth at risk for prolonged symptoms

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• Child meets the study eligibility criteria
• Non-English speaking
• ED or specialty provider caring for at least one patient via the mobile Health (mHealth)-facilitated care handoff strategy
• Non-English speaking

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 26954410 BACKGROUND

• 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.

  PMID: 33036827 BACKGROUND

• 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.

  PMID: 29064869 BACKGROUND

• 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.

  PMID: 31460948 BACKGROUND

• 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.

  PMID: 27617669 BACKGROUND

• 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.

  PMID: 36730797 BACKGROUND

• 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.

  PMID: 38904136 DERIVED

MeSH Terms

Conditions

Brain Concussion; Emergencies

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel J Corwin, MD, MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Godfrey

CONTACT

267-425-0386; godfreym2@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group intervention arm compared to historical controls

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 23, 2023
• Study Start: March 11, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 20, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)