RTL Concussion Communication

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Concussion, Mild; Sports Injuries in Children; Cognitive Impairments; Post Concussion Symptoms; Cognitive Impairments, Mild; Learning Disturbance; Multidisciplinary Care Team; Team Nursing
• Intervention / Treatment: Behavioral: InjureFree

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph M Fetta, PhD; Phone Number: 8609613798; Email: joseph.fetta@ufl.edu
• Study Contact Backup: Name: Angela Starkweather, PhD; Phone Number: (352) 273-6323; Email: a.starkweather@ufl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: InjureFree Concussion Communication Tool; During the second phase of this trial, participants assigned to the experimental group (Buchholz and Gainesville High Schools) will receive the current standard of care for return to learn following SRRC with the addition of InjureFree, a wed-based injury tracking and communication tool. InjureFree will serve as a centralized area for concussion management team members to communicate and document participant progress with the return to learn program.	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
No Intervention: Control; During the second phase of this trial, participants assigned to the control group (Newberry, Santa Fe and Eastside High Schools) Will not receive any intervention other than the current standard of care for return to learn following SRRC currently in place.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (Estimated): August 28, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Estimated): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: communication; concussion; Implementation science; Post-concussion syndrome; concussion management; Interdisciplinary team; return to learn; return to school; multidisciplinary care team
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Neurobehavioral Manifestations; Neurocognitive Disorders; Craniocerebral Trauma; Trauma, Nervous System; Cognition Disorders; Neurodevelopmental Disorders; Communication Disorders; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Cognitive Dysfunction; Post-Concussion Syndrome; Athletic Injuries; Learning Disabilities; Brain Concussion
• Other Study ID Numbers: IRB202301378

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IDP will be made available to other researchers upon request. Only de-identified information will be made available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No