Facilitating Access to Specialty Treatment

Mild Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05741411
• Other study ID #: 22-019755
• Secondary ID: K23NS128275
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: March 2027

Study information

• Verified date: April 2024
• Source: Children's Hospital of Philadelphia
• Contact: Melissa Godfrey
• Phone: 267-425-0386
• Email: godfreym2[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 2027
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

• Previously enrolled in the study

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion, Intermediate
• Concussion, Mild
• Concussion, Severe
• Mild Traumatic Brain Injury

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum In: JAMA. 2016 Jun 21;315(23):2624. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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