RTL Concussion Communication

Concussion, Mild Clinical Trial

Official title:

Evaluation of Return-to-learn Concussion Management Coordination and Social Determinants of Health on Patient-centered Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06212726
• Other study ID #: IRB202301378
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 28, 2024
• Est. completion date: August 30, 2026

Study information

• Verified date: January 2024
• Source: University of Florida
• Contact: Joseph M Fetta, PhD
• Phone: 8609613798
• Email: joseph.fetta[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is aimed at improving health outcomes for adolescents who sustain sport and recreation related concussions (SRRC) by enhancing Return to Learn (RTL). The study will conduct a quasi-experimental school-based 2 phase study involving 200 students with SRRC. The first phase will be descriptive to evaluate current standards (n=50). Phase 2 will compare students whod receive either standard of care RTL (n=75) or RTL augmented by a communication tool (RTC+; n=75).

Description:

Up to 3.8 million secondary school students are diagnosed with a sport and recreation related concussion (SRRC) annually in the U.S., which can have a detrimental impact on educational attainment, a social determinant of health (SDOH) that is linked with college admission and graduation, employment, income status and social class. This research will address this significant public health problem by gaining a deeper understanding of the relationships among SRRC and SDOH and examine the impact of concussion management team communication on return to learn (RTL) outcomes for students following an SRRC. This research has significant potential to improve RTL outcomes of secondary school students and may provide evidence to support policy-level changes to reduce disparities in SRRC management, especially among low-resource school districts.

The three research aims of this study will proceed as follows:

Aim 1 will examine the relationships among SDOH, SRRC-related symptoms, and RTL milestones among a diverse population of adolescents and young adult secondary school students following SRRC. This aim will be achieved by enrolling and tracking secondary school students who sustain an SRRC over a 12-month period.

Aim 2 will compare RTL milestones among secondary school students following SRRC who are managed by an interdisciplinary concussion management team that uses standard or care plus a communication tool intervention or only standard of care for the RTL process.

Aim 3 will examine differential RTL outcomes between groups (standard of care plus a communication tool intervention vs. only standard of care) based on SDOH, sex as a biological variable, and pre-injury health status among secondary school students following SRRC.

The study aims to reduce disparities in timely management of SRRC during the process of RTL, achievement of RTL milestones and improvement of SRRC-related symptoms in the context of SDOH.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 30, 2026
• Est. primary completion date: June 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

Inclusion Criteria:

• Student: enrolled in Alachua County Public Secondary Schools who are age 14 or older and have sustained a new SRRC and voluntarily enrolled in the OSMI (Orthopaedic Sports Medicine Institute) concussion management program

• Parent: primary point of contact for the assenting student verified through the school

Exclusion Criteria:

• Student: Age 13 or younger, Not enrolled in Alachua County Public Schools, Did not sustain SRRC during school year

• Parent: not a verified point of contact for the assenting student

Related Conditions & MeSH terms

• Athletic Injuries
• Brain Concussion
• Cognitive Dysfunction
• Cognitive Impairments
• Cognitive Impairments, Mild
• Concussion, Mild
• Learning Disabilities
• Learning Disturbance
• Post Concussion Symptoms
• Post-Concussion Syndrome
• Sports Injuries in Children

Intervention

Behavioral:
• InjureFree
The InjureFree software is a commercialized injury incident management platform for organizations working in sports and athlete care and is focused on providing administrators and caregivers' technology to enhance coordination of care. InjureFree will be utilized to track concussion management and communication following SRRC at Buchholz and Gainesville High Schools. This will not modify the current standard of practice for healthcare delivery, it will only modify the communication between members of the concussion management team

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant self-efficacy in concussion symptom management	Participant will demonstrate increased ability in self-management of post-concussion symptoms. To measures self efficacy, the research team will utilize a 10-item scale with answers on a likert scale from 1-10 with 1 being not at all confident and 10 being completely confident. Examples of items are: How confident are you that you can manage your concussion symptoms with the instructions provided by the Concussion Management Team (CMT)? How confident are you that you can manage your return to the classroom with the instructions provided by the CMT? How confident are you that you can judge when the changes in your concussion symptoms means you should visit a doctor? How confident are you that you can exercise without making concussion symptoms worse? How confident are you that you can keep the symptoms of your concussion from interfering with the things you want to do?	1 month
Primary	Communication satisfaction	Participant will express level of satisfaction with concussion management team (CMT) communication and care delivery throughout the return to learn (RTL) process. RTL communication satisfaction will be measured with a series of questions. The questions will consist of 5 items asking about levels of satisfaction with care coordination, availability of providers and CMT members, education on SRRC provided, understanding of RTL process and frequency of communication from CMT members during RTL. A 4-point Likert scale will be used ranging from not at all satisfied to very satisfied.	1 month
Secondary	Post concussion symptom reduction	Participant will experience a decreased symptom burden as evidenced by scores utilizing the Post-Concussion Symptom Scale (PCSS). The PCSS is a widely used tool for assessing post-concussion symptoms. It measures various physical, cognitive, and emotional symptoms that individuals may experience following a concussion. Participants indicate symptom severity on a scale from 0-6 with zero being no symptoms and six being severe symptoms. Possible scores range from 0 to 132 with higher scores indicating a more severe burden of symptoms.	1 month