RTL Concussion Communication

NCT06212726 | Withdrawn

• 1 other identifier: IRB202301378
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Keywords

concussion; Post-concussion syndrome; return to learn; return to school; concussion management; multidisciplinary care team; Interdisciplinary team; Implementation science; communication

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Post concussion symptom reduction

  1 month

Study Arms (2)

InjureFree Concussion Communication Tool

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

InjureFree 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

InjureFree Concussion Communication Tool

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

MeSH Terms

Conditions

Brain Concussion; Post-Concussion Syndrome; Cognitive Dysfunction; Learning Disabilities; Communication

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: January 19, 2024
• Study Start: August 28, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share