Colorado Early Intervention Outcomes Research Using Innovative Patient-Reported Outcome (PRO) Measures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 主要终点
- YC-PEM e-PRO Value as assessed by proportion of participants viewing e-PRO online report
研究概览
简要总结
A major goal of early intervention (EI) is to employ a family-centered approach to helping children to optimally function at home and in the community. However, the effects of EI are poorly understood. The aims of this project are: 1) to test the feasibility, acceptability, and value of introducing novel electronic patient-reported outcome (e-PRO) measures in EI, to strengthen family-centered EI care; and 2) to obtain and pair these outcomes data with EI program data, to further determine the value of e-PRO data collection for examining links between EI service use and functional outcomes among families who are enrolled in a large, urban EI program.
详细描述
Approximately 5,800 infants and toddlers with developmental disabilities (e.g., cerebral palsy, Down syndrome, complex chronic conditions) and delays access Early Intervention Colorado (EI-CO) annually. A primary goal of EI-CO is to employ a family-centered care approach to help children optimally function at home and in the community. Hence, early intervention is a common source of rehabilitation (i.e., physical, occupational, speech and language therapy) for EI-CO eligible families.
However, the effects of EI-CO are poorly understood. Numerous challenges exist with obtaining EI-CO outcomes data, including a paucity of validated and feasible functional outcome measures for use in EI outcomes reporting. These challenges have resulted in inadequate knowledge about EI service use and outcomes to guide service delivery. Despite these challenges, recent policy changes have resulted in EI-CO service providers being pressed to ensure high quality care with limited resources and evidence to guide their clinical decision-making about effective and efficient interventions. This proposal addresses the need to fill critical knowledge gaps about the adequacy of EI services with an eye toward improving care quality.
This study involves families who have/are receiving EI-CO services through Rocky Mountain Human Services (RMHS), the largest EI program in Denver Metro. The purpose of this study is to test the feasibility, acceptability, and value of collecting electronic patient-reported outcomes (e-PRO) data to engage families when their child is due for an annual evaluation of progress. To further demonstrate the value of e-PRO data collection, these data will be paired with program data to estimate the association between EI-CO service use and functional outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caregiver is at least 18 years old;
- •Caregiver can read, write, and speak English or Spanish;
- •Caregiver had internet access;
- •Caregiver has a child between 0-3 years old who had received early intervention at RMHS for at least 3 months.
排除标准
- •Caregiver is less than 18 years old
- •Caregiver reads, speaks, and writes in a language other than English or Spanish
- •Caregiver does not have internet access
- •Caregiver has a child who has received EI services for less than 3 months
- •Caregiver has a child older than 3 years (36 months)
研究组 & 干预措施
e-PRO
EI service coordinators participated in a 90-minute training on the study protocol, to gain clearance to recruit families when they were being contacted to schedule their annual reviews of progress. The recruitment protocol was later modified in response to low enrollment, such that a designated EI staff member was paired with research staff to recruit participants. Eligible and interested caregivers visited the project website to create an account, confirmed study eligibility, provided informed consent and HIPAA authorization for abstracting select EI service use data, and completed a demographic questionnaire and the Young Children's Participation and Environment Measure (YC-PEM) e-PRO. Caregivers received immediate access to an online report summarizing their e-PRO responses to share with their child's EI team
干预措施: Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO) (Behavioral)
结局指标
主要结局
YC-PEM e-PRO Value as assessed by proportion of participants viewing e-PRO online report
时间窗: up to 4 weeks
The percentage of participants who viewed a summary of their e-PRO responses via an online report was estimated.
YC-PEM e-PRO Feasibility as assessed by enrollment rate
时间窗: up to 4 weeks
Enrollment rate was estimated as the proportion of eligible participants who enrolled in the study. The success of feasibility was determined as e-PRO enrollment rates of 50% or higher based on what is known about the percentage of families who opt into family assessment as part of usual care.
YC-PEM e-PRO Acceptability as assessed by caregiver perceptions of overall helpfulness
时间窗: up to 4 weeks
Caregiver responses to an open-ended item were coded into a one of three categories (yes, helpful; somewhat helpful; not helpful) to create a new variable that captured the extent to which caregivers perceived the YC-PEM e-PRO to be useful for planning EI care.
YC-PEM e-PRO Feasibility as assessed by completion rate
时间窗: up to 4 weeks
Feasibility was determined as the proportion of participants who enrolled that completed the YC-PEM e-PRO. The success of feasibility was determined as completion rates of 50% or higher based on family assessment completion rates within usual care.
YC-PEM e-PRO Feasibility as assessed by completion time in minutes and seconds
时间窗: up to 4 weeks
The success of feasibility was determined as e-PRO completion time of less than 45 minutes based on family assessment completion time within usual care.
次要结局
未报告次要终点