Clinical trial NCT06212726: RTL Concussion Communication
Official title: Evaluation of Return-to-learn Concussion Management Coordination and Social Determinants of Health on Patient-centered Outcomes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
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
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Participant self-efficacy in concussion symptom management
timeFrame: 1 month
measure: Communication satisfaction
timeFrame: 1 month
Secondary outcomes:
measure: Post concussion symptom reduction
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References: