RTL Concussion Communication

NCT ID: NCT06212726

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-28
• Study Completion Date: 2026-08-30

Brief 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).

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.

Conditions

Concussion, Mild; Post Concussion Symptoms; Cognitive Impairments; Cognitive Impairments, Mild; Multidisciplinary Care Team; Team Nursing; Sports Injuries in Children; Learning Disturbance

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

InjureFree

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IRB202301378

Identifier Type: -

Identifier Source: org_study_id