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临床试验/NCT06212726
NCT06212726撤回不适用

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

University of Florida0 个研究点目标入组 200 人开始时间: 2024年8月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
200
主要终点
Participant self-efficacy in concussion symptom management

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
14 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: InjureFree (Behavioral)

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.

结局指标

主要结局

Participant self-efficacy in concussion symptom management

时间窗: 1 month

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?

Communication satisfaction

时间窗: 1 month

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.

次要结局

  • Post concussion symptom reduction(1 month)

研究者

申办方类型
Other
责任方
Sponsor

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