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Concussion mHealth ED to Specialist

Primary Purpose

Mild Traumatic Brain Injury, Concussion, Mild, Concussion, Severe

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

mHealth assisted specialist access

About this trial

This is an interventional other trial for Mild Traumatic Brain Injury focused on measuring mobile health, emergency department, persistent post-concussion symptoms, ecological momentary assessment

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria for concussed subjects: Present to the Children's Hospital of Philadelphia (CHOP) Emergency Department within 72 hours of head injury Meet criteria for concussion as defined by the 5th 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 (digital monitoring platform English-language only) 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 mHealth-facilitated care handoff strategy Exclusion Criteria for providers: Non-English speaking

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Concussed youth at risk for prolonged symptoms

Arm Description

Outcomes

Primary Outcome Measures

Proportion of participants demonstrating fidelity to the intervention

At least 1 interaction with a specialty provider either in person or via telehealth during the acute study period

Secondary Outcome Measures

Patient and provider-defined appropriateness of the intervention

Mean System Usability Score out of 100 with >=70 defined as acceptable appropriateness

Patient and provider-defined acceptability of the intervention obtained using a Technology Assistance Model framework

Full Information

NCT ID

NCT05741411

First Posted

February 14, 2023

Last Updated

February 14, 2023

Sponsor

Children's Hospital of Philadelphia

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

1. Study Identification

Unique Protocol Identification Number

NCT05741411

Brief Title

Concussion mHealth ED to Specialist

Official Title

Mobile Health-Facilitated Specialist Management to Improve Outcomes in Pediatric Concussion Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 2023 (Anticipated)

Primary Completion Date

February 2026 (Anticipated)

Study Completion Date

July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital of Philadelphia

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The goal of this implementation-based clinical trial is to assess the feasibility of a mobile health (mHealth) tool to facilitate specialist access and care handoffs for 12-17 year old pediatric concussion patients presenting to the emergency department with moderate-to-high risk of developing persistent post-concussion symptoms (PPCS). Participants will report their symptoms twice daily through a digital health platform that is linked to their electronic health record and prompts referral to specialty care when indicated.

Detailed Description

Patients will be evaluated using the 5P rule. Those scoring 4 or higher (moderate to high risk for persistent post-concussion symptoms) will be enrolled. A digital health platform will prompt subjects to report their current symptoms twice daily throughout the acute study period (28 days following injury). A nurse navigator will have access to the symptom data and will facilitate scheduling of in-person or telehealth visits with a concussion specialist within 10 days of injury and then 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

mobile health, emergency department, persistent post-concussion symptoms, ecological momentary assessment

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Concussed youth at risk for prolonged symptoms

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

mHealth assisted specialist access

Intervention Description

Concussed subjects will be prompted to report current symptoms twice a day via a digital health platform. A nurse navigator will have access to the symptom data and will facilitate scheduling an in person or telehealth specialist visit as indicated by the symptom data. Symptoms will continue to be monitored through the acute study period with additional clinical visits occurring according to clinical need.

Primary Outcome Measure Information:

Title

Proportion of participants demonstrating fidelity to the intervention

Description

At least 1 interaction with a specialty provider either in person or via telehealth during the acute study period

Time Frame

28 days from injury

Secondary Outcome Measure Information:

Title

Patient and provider-defined appropriateness of the intervention

Description

Mean System Usability Score out of 100 with >=70 defined as acceptable appropriateness

Time Frame

Within 1 year of completing study procedures

Title

Patient and provider-defined acceptability of the intervention obtained using a Technology Assistance Model framework

Time Frame

Within 1 year of completing study procedures

Other Pre-specified Outcome Measures:

Title

Incidence of Persistent Post-Concussion Symptoms (PPCS)

Description

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

Time Frame

28 days from injury

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Melissa Godfrey

Phone

267-425-0386

godfreym2@chop.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel J Corwin, MD, MSCE

Organizational Affiliation

Children's Hospital of Philadelphia

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26954410

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.

Results Reference

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PubMed Identifier

33036827

Citation

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.

Results Reference

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PubMed Identifier

29064869

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.

Results Reference

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PubMed Identifier

31460948

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.

Results Reference

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PubMed Identifier

27617669

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.

Results Reference

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PubMed Identifier

36730797

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.

Results Reference

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Concussion mHealth ED to Specialist

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