Recruiting NCT05741411
Facilitating Access to Specialty Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RPM-assisted specialist access.
- Who it may be relevant to
- Registry conditions: Mild Traumatic Brain Injury, Concussion, Mild, Concussion, Severe, Concussion, Intermediate. Basic parameters: 13 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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
Primary outcome measures
- Incidence of Persisting Post-Concussion Symptoms (PPCS, Primary Effectiveness) [Time frame: 28 days from injury]
- Percent of participants meeting referral criteria who interact with a specialty care provider (Fidelity, Primary Implementation) [Time frame: 28 days from injury]
Secondary outcome measures (8)
- Modeling of PPCS (Secondary Effectiveness) [Time frame: 28 days from injury]
- Days until return to symptoms baseline (Secondary Effectiveness) [Time frame: Up to 90 days from injury]
- Days until clearance (Secondary Effectiveness) [Time frame: Up to 90 days from injury]
- Days until return to school (Secondary Effectiveness) [Time frame: Up to 90 days from injury]
- Modeling of fidelity (Secondary Implementation) [Time frame: 28 days from injury]
- Patient-defined quantitative appropriateness (Secondary Implementation) [Time frame: Within 1 year of completing study procedures]
- Patient-defined qualitative appropriateness (Secondary Implementation) [Time frame: Within 1 year of completing study procedures]
- Provider-defined qualitative acceptability (Secondary Implementation) [Time frame: Within 1 year of completing study procedures]
Eligibility criteria
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 at the initial head injury visit
- Previously enrolled in the study
- Inability to complete study procedures.
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Children's Hospital of Philadelphia — Philadelphia
Publications
- 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 PMID 26954410
- 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
- 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
- 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
- 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
- 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
- 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 PMID 38904136
Identifiers
NCT: NCT05741411 · 22-019755 · K23NS128275