Promoting Recovery in Children Who Sustain a Mild Traumatic Brain Injury: mTBI Evaluation and Management (TEaM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 3
- 主要终点
- Time to return to full activity post injury
研究概览
简要总结
The purpose of this study is to evaluate a multi-disciplinary, multi-setting intervention with the goal of improving outcomes for children who have experienced a mild traumatic brain injury (mTBI). The project aims to improve and support mTBI diagnosis and management, and improve critical decision making by clinicians during their interaction with the injured child, their family, and their school.
详细描述
Emergency, urgent care, and primary care providers participating in the study will be block randomized in a 1:1 ratio by practice type to receive the intervention or continue with their standard practice. All enrolled clinicians (both trained and control providers) patients they care for will be screened for inclusion in the trial.
Additionally, a pre/post intervention will be layered upon the randomized educational intervention to evaluate the effects of the information technology decision support tool (i.e. eMR) in isolation of the clinician education intervention. The 32-month mTBI patient enrollment period will be divided into two 16 months segments. The first 16 months will be without the eMR intervention being visible, and the remaining 16 months post eMR screening and decision support deployment in the ED and UC. This study design allows us to evaluate the independent and interactive effects of the decision support tool and educational intervention.
Enrolled children will be followed for up to three months post injury to ascertain the effect of the interventions on the primary aim (reduction of school problems/performance) and secondary aims.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROVIDER INCLUSION CRITERIA
- •Actively practicing physician or APP in the CHOA System
- •Primary practice in either ED, UC, and/or PCP
排除标准
- •Inability or unwillingness to provide written/electronic informed consent
- •Unable to fulfill study training / education requirements
- •CHILD INCLUSION CRITERIA - RETROSPECTIVE
- •School age (5-18 yoa)
- •Evaluated in ED / UC / PCP within 72 hours of injury
- •Discharged home from ED / UC / PCP (e.g., not admitted to hospital)
- •CHILD EXCLUSION CRITERIA - RETROSPECTIVE
- •Non-English speaking
- •Known severe developmental delay or known severe psychiatric history
- •Known prior severe brain injury
- •Known mTBI within past 3 months
- •First mTBI visit outside of CHOA network
- •CHILD INCLUSION CRITERIA - PROSPECTIVE
- •Meets above inclusion for retrospective portion plus:
- •mTBI likely present as defined by:
- •Positive diagnosis by clinician or mTBI OR
- •Positive triage screen plus positive symptom checklist
- •CHILD EXCLUSION CRITERIA - PROSPECTIVE
- •Does not meet above exclusion for retrospective portion plus:
- •Requests to Opt-Out via e-mail or first phone contact
- •Inability or unwillingness to provide verbal informed telephone consent/assent
研究组 & 干预措施
TEaM Intervention Group
Dedicated Provider Education plus Information Technology Support. The IT support includes addition of an eMR concussion screening, followed by an alert to the provider, followed by a structured assessment / evaluation template.
干预措施: TEaM Intervention (Behavioral)
Control Group
Standard medical protocol for the management of mTBI in children. This group will not receive interventional Provider Training on the TEaM concussion evaluation examination and utilization of the eMR template.
干预措施: Standard of Care (Behavioral)
结局指标
主要结局
Time to return to full activity post injury
时间窗: Up to 3 months post-intervention
Measured by serial PCSI and return to activity. PCSI Total score (PPCS-Persistent Post-Concussive Symptoms - will be calculated via the PCSI Total Score with scores classified as "Recovered" or "Non-Recovered (PPCS)" based on the Reliable Change Metrics that reflect recovery or not (e.g., for Parent and Adolescent PCSI Total RAPID score \<5 indicates symptom recovery). Total score ranges from 0 to 100%. Lower % with PPCS in Intervention group compared to Control indicates better study outcome.
Change in CLASS survey score
时间窗: 1 week, 2 week and 1 month post return to school
Concussion Learning Assessment and School Survey (CLASS), identifies the types of problems students experienced across all grades. Total score range 0-42 (14 individual items rated 0-3, 0 = no problem, 3 = significant problem). Higher score reflects a greater problem/ worse outcome.
Change in Peds-QL score
时间窗: 1 week, 2 week and 1 month post return to school
Pediatric Quality of Life (PedsQL) scale, includes 23 items, rated 0-4 (assesses different areas of function (physical, emotional, social, school) to determine if the child is having any problems with various tasks in each functional area and if so, how often the difficulty occurs). 4 sub scales (general health 8 items 0-4 scaling, 0-32 total; social 5 items, 0-4 scaling, 0-20; school 5 items, 0-4 scaling, 0-20; emotional 5 items, 0-4 scaling, 0-20, 0=it is never a problem, 4= it is almost always a problem). Higher raw score reflects worse overall quality of life. Items are calculated and transformed into an overall score with a range of 0-to-100 points, with 100 points indicating better HRQoL.
Post-concussion symptom inventory (PCSI) total score at 3 months post injury
时间窗: 3 months post injury
Persistent post-mTBI symptoms as measured by the PCSI total score at 3 months post injury. Total score range, 0-24 (4 symptoms on a 0-6 scaling). Higher score reflects a greater problem/worse outcome.
Change in Post-concussion symptom inventory (PCSI) total score
时间窗: 1 week, 2 week and 1 month post return to school
Change in Post-concussion symptom inventory (PCSI). Total score range, 0-24 (4 symptoms on a 0-6 scaling). Higher score reflects a greater problem/worse outcome.
次要结局
- Primary Care Physician (PCP) follow up visits(3 months post-intervention)
- Number of letters sent to school(2 weeks post-injury)