Optimization and Implementation Trial of a User-Centered Emergency Care Action Plan for Infants with Medical Complexity
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Inpatient hospitalization
研究概览
简要总结
An Emergency Care Action Plan (ECAP) is a tool intended to be helpful to providers when treating a child with complex medical needs during an emergency. Once created, ECAPs are added to the Electronic Health Record (EHR), shared with the child's caregiver(s), and kept up by all of those involved in a child's care.
The goal of this study is to measure important health outcomes (ex. inpatient days, emergency department visits) in terms of the use of the ECAP for infants discharged from the Neonatal Intensive Care Unit (NICU). This study will also measure other real-time potential challenges related to the use of the ECAP including, but not limited to, if it is being used, if providers and caregivers want to use it, and if they keep using it over a long period of time.
详细描述
National expert recommendations and human-centered design principles were used to optimize an Emergency Care Action Plan (ECAP) for infants with medical complexity. This study will implement and monitor the effectiveness and feasibility of the optimized Emergency Care Action Plan for infants with medical complexity. The primary objective is to determine the effectiveness of a user-centered Emergency Care Action Plan for infants with medical complexity on emergency health care utilization and cost metrics. The secondary objective is to monitor and evaluate barriers and facilitators to the current and widespread implementation of a user-centered Emergency Care Action Plan for infants with medical complexity.
Research participants will be assigned by chance to receive an ECAP or standard care. Caregivers (parent/legal guardian) of infant participants will be asked to complete periodic surveys during a one-year feasibility trial period. If assigned, caregivers will be asked to help with the process of creating an ECAP for their child.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0 to 6 months
- •Admitted to the University of Vermont Medical Center Neonatal Intensive Care Unit (NICU)
- •Meets or is expected to meet Children with Medical Complexity status as determined by the treating NICU clinician and defined as "children with multiple significant chronic health problems including multiple organ systems, which result in functional limitations, high health care needs or utilization, and often require need for, or use of, medical technology."
排除标准
- •Does not have a caregiver participant who agrees to their participation in the study to complete follow-up surveys
- •Does not intend to use University of Vermont Health Network and affiliated sites for care during the one-year trial period
结局指标
主要结局
Inpatient hospitalization
时间窗: Day 0 (NICU discharge) to Month 12
Number of inpatient hospital days
次要结局
- Avoidance of ED visits(Day 0 (NICU discharge) to Month 12)
- Number of ED visits(Day 0 (NICU discharge) to Month 12)
- ED length of stay(Day 0 (NICU discharge) to Month 12)
- Interfacility transfers(Day 0 (NICU discharge) to Month 12)
- Caregiver stress(Day 0 (NICU discharge) to Month 12, assessed at quarterly intervals (Month 3, 6, 9, 12))
- Caregiver self-efficacy(Day 0 (NICU discharge) to Month 12, assessed at quarterly intervals (Month 3, 6, 9, 12))
研究者
Christian Pulcini
Principal Investigator
University of Vermont