Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
210 participants
INTERVENTIONAL
2024-03-11
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Concussed youth at risk for prolonged symptoms
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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)
* Child meets the study eligibility criteria
* ED or specialty provider caring for at least one patient via the mobile Health (mHealth)-facilitated care handoff strategy
Exclusion Criteria
* 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.
* Non-English speaking
* Non-English speaking
13 Years
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Daniel J Corwin, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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, 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.
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, 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.
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.
Other Identifiers
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22-019755
Identifier Type: -
Identifier Source: org_study_id
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