Utilizing Mobile Health to Expedite Access to Specialty Care for Youth Presenting to the Emergency Department With Concussion at Highest Risk of Developing Persisting Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Incidence of Persisting Post-Concussion Symptoms (PPCS, Primary Effectiveness)
研究概览
简要总结
The goal of this hybrid implementation-effectiveness study is to evaluate the effectiveness (hastened recovery times) and feasibility (fidelity in connecting to concussion specialty care) of a novel mobile health intervention, designed to reduce disparities in access to specialty care through the use of remote patient monitoring (RPM) to facilitate care hand-off from the emergency department (ED) to concussion specialty care. Participants will report their symptoms and activity once daily through RPM chat technology that is linked to their electronic health record and prompts referral to specialty care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for concussed subjects:
- •Males and females age 13 - 18
- •Present to the Children's Hospital of Philadelphia (CHOP) Emergency Department (ED) within 72 hours of head injury
- •Meet criteria for concussion as defined by the most recent International Consensus Statement on Concussion
- •Own a smartphone
- •Meet criteria for moderate-to-high risk for Persistent Post-Concussion Symptoms according to 5P rule (score >3/12)
排除标准
- •for concussed subjects:
- •Glasgow Coma Scale score <13
- •Lower extremity trauma
- •A prior concussion within 1 month
- •Non-English speaking
- •Admission to the hospital at the initial head injury visit
- •Previously enrolled in the study
- •Inability to complete study procedures.
- •Inclusion Criteria for parents:
- •Child meets the study eligibility criteria
- •Exclusion Criteria for parents:
- •Non-English speaking
- •Inclusion Criteria for providers:
- •ED or specialty provider caring for at least one patient via the mobile Health (mHealth)-facilitated care handoff strategy
- •Exclusion Criteria for providers:
- •Non-English speaking
研究组 & 干预措施
Concussed youth at risk for prolonged symptoms
干预措施: RPM-assisted specialist access (Other)
结局指标
主要结局
Incidence of Persisting Post-Concussion Symptoms (PPCS, Primary Effectiveness)
时间窗: 28 days from injury
Persistence of at least 3 concussion-like symptoms above the pre-injury state beyond 28 days from injury, defined as a positive difference between patient-reported symptoms and the perceived pre-injury symptom rating
Percent of participants meeting referral criteria who interact with a specialty care provider (Fidelity, Primary Implementation)
时间窗: 28 days from injury
Among those participants who flag to see a specialist, at least 1 interaction with a specialty provider either in person or via telehealth during the acute study period
次要结局
- Days until clearance (Secondary Effectiveness)(Up to 90 days from injury)
- Modeling of fidelity (Secondary Implementation)(28 days from injury)
- Patient-defined qualitative appropriateness (Secondary Implementation)(Within 1 year of completing study procedures)
- Days until return to symptoms baseline (Secondary Effectiveness)(Up to 90 days from injury)
- Modeling of PPCS (Secondary Effectiveness)(28 days from injury)
- Days until return to school (Secondary Effectiveness)(Up to 90 days from injury)
- Patient-defined quantitative appropriateness (Secondary Implementation)(Within 1 year of completing study procedures)
- Provider-defined qualitative acceptability (Secondary Implementation)(Within 1 year of completing study procedures)