Implementation of a Clinical Pathway for Paediatric Concussion in Acute Care Settings: Measuring Health Outcomes of the RECOVER Intervention Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,878
- 试验地点
- 2
- 主要终点
- Clinical Outcome
研究概览
简要总结
The project encompasses the development and implementation of an acute care, pediatric concussion clinical pathway at 5 pediatric emergency departments in the province of Alberta (Canada).
详细描述
Clinical pathways (CPs) do not currently guide the care of children with concussions presenting to acute care settings in Alberta. The Alberta Health Services Maternal Newborn Child & Youth (MNCY) Strategic Clinical Network established a work group to develop best-practice, evidence-based Clinical Practice Guidelines for the management of concussion that are being translated into specific CPs for different clinical settings.
The research has three key objectives:
- Design an evidence-based, knowledge-user informed, and theory-driven approach to implementation of a clinical pathway for acute care of pediatric concussion. Guided by the Theoretical Domains Framework (TDF), the investigators will assess barriers and facilitators likely to influence uptake of the CP in acute care settings. The results of that assessment will inform implementation strategy design, again guided by the TDF.
- Evaluate the impact of the implementation of the CP on patient-centered outcomes using a stepped wedge cluster randomised trial. Within the context of a stepped wedge cluster randomised trial, the investigators will assess relevant process and clinical outcomes to determine whether implementation of the CP results in significant uptake of the pathway, as well as higher patient satisfaction and better health outcomes following concussion.
- Determine whether the implementation and use of a CP for acute care of pediatric concussion is associated with changes in health care utilization and associated costs. Health care utilization and costs associated with care of concussion will be compared before and after the implementation of the CP. Utilization and costs are expected to remain stable or decline following implementation of the CP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Each site will be randomized to a start date. Once a site starts the clinical pathway, the clinical pathway tools (assessment, education and referral tools) will be utilized by staff in that particular emergency department. Patients and parents will be unaware of clinical pathway.
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children evaluated for concussion (including their parents) January 30 - November 30, 2019 at the 5 participating emergency departments
排除标准
- •moderate to severe brain injury
结局指标
主要结局
Clinical Outcome
时间窗: Through study enrollment, plus a 6 follow-up period, 15 months
Time to symptom resolution using weekly ratings by patients and parents of whether patient has returned to pre-injury status. Parents and children were asked asked to complete a numeric scale of 0 to 10 (where 0 is very bad and 10 is back to normal), how do you feel now?
Process Outcome
时间窗: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Measurement of clinician utilization of the newly implemented clinical pathway. Clinician utilization was represented by proportion of clinician-completed 5P assessments per diagnosed concussion. Data was also collected on the number of high risk referrals made through the clinical pathway and the number of handouts provided by the clinician to patients and families.
次要结局
- Emergency Department satisfaction(Through study enrollment (Jan 30 - Nov 30, 2019) 11 months)
- Rate of Head CT scans ordered(Through study enrollment (Jan 30 - Nov 30, 2019) 11 months)
- Post-concussive symptom ratings(Through study enrollment (Jan 30 - Nov 30, 2019) 11 months)
- Quality of life ratings(4 weeks post injury)
- Adherence to discharge recommendations(Through study enrollment (Jan 30 - Nov 30, 2019) 11 months)
- RECOVER web portal usage(1 year)
- Rate of diagnosed concussions(Through study enrollment (Jan 30 - Nov 30, 2019) 11 months)