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| ID | Type | Description | Link |
|---|---|---|---|
| K23NS128275 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concussed youth at risk for prolonged symptoms | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria for concussed subjects:
Exclusion Criteria for concussed subjects:
Inclusion Criteria for parents:
Exclusion Criteria for parents:
Inclusion Criteria for providers:
Exclusion Criteria for providers:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Godfrey | Contact | 267-425-0386 | godfreym2@chop.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel J Corwin, MD, MSCE | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26954410 | Background | 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. | |
| 33036827 |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Single group intervention arm compared to historical controls
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| 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 |
| 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. |
| 29064869 | 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. |
| 31460948 | 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. |
| 27617669 | 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. |
| 36730797 | 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. |
| 38904136 | Derived | 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. |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |