Implementation of the Pain and Irritability of Unknown Origin (PIUO) Pathway in Community Pediatric Practices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Implementation Adoption
研究概览
简要总结
The Pain and Irritability of Unknown Origin (PIUO) Pathway is a clinical pathway that was developed to evaluate and manage unexplained pain and irritability for children with severe neurological impairments (SNI) who cannot verbally communicate 'where it hurts'. The investigators studied the usefulness of the Pathway with families and expert clinicians in 4 centres across Canada. The aim of this Phase 2 study is to determine whether this tool can transfer from hospital research centres into the community. The Pathway will be used by community pediatricians across British Columbia (BC) when they see patients with PIUO. The investigators want to know how well these pediatricians can follow the Pathway. The goal is to create a systematic, cohesive approach to enhance the clinical care for all children with complex medical needs experiencing PIUO.
详细描述
BACKGROUND: Many children with brain-based developmental disorders and their families, specifically those with SNI, experience on-going and difficult-to-treat PIUO. However, currently, no consensus exists among healthcare providers about how to best approach PIUO, which likely exacerbates the challenges in faced by parents in taking care of their children with SNI experiencing PIUO. The PIUO Pathway was developed to streamline pain management and care for these children, who are among the most vulnerable seen in any hospital or clinic. To-date, the PIUO Pathway has only been used by expert clinicians in complex care, palliative medicine, and pain medicine, and in tertiary pediatric care settings. Community pediatricians are not yet trained to use this tool, which limits access of such care to the tertiary care level and/or through access to specialist supports. Training front-line clinicians, specifically community pediatricians, to use the PIUO Pathway holds the potential to delivering sustained, effective, and quality community care that can better serve and reach this vulnerable population of Canadian children and families.
AIMS: To advance the assessment and treatment of PIUO in children with SNI and their families, the primary aims and respective research questions of this hybrid implementation-effectiveness study are:
Primary Implementation Aim 1: To determine the feasibility and effectiveness of, and factors that influence implementing the Pain Pathway. Specifically, do the implementation strategies show promise in facilitating the implementation of the Pain Pathway in community practice?
Primary Intervention Aim 2: To assess the effectiveness of the Pain Pathway intervention on relevant outcomes of children with SNI and their families. Specifically, does the Pain Pathway work to help manage PIUO for children with SNI presenting and their families when seen in a community practice?
METHODS
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
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain Pathway Intervention Inclusion Criteria:
- •Children aged 6 months to 18 years with SNI (from any cause) with unexplained pain and irritability and whose cognitive or communication impairments prevent determination of pain location, cause, and type will be eligible to participate.
- •Eligible children will have cognitive impairment or be non-verbal. Parents should have sufficient English skills, or have access to assistance, to participate in the clinic visits and complete survey tools.
- •Pain Pathway Intervention
排除标准
- •Children not within the specified age range
- •Children with communication capabilities and cognitive development to localize their pain
- •Children that have an explained and treatable cause of pain and irritability. Parents that do not have sufficient English skills, or have access to assistance, to participate in the clinic visits and complete survey tools.
- •Implementation Participant Inclusion Criteria:
- •General pediatricians
- •Practicing in a community clinic in British Columbia
- •Implementation Participant Exclusion Criteria:
- •Healthcare professionals who are not general pediatricians (e.g., pediatrician specialists, nurse practitioners, nurses, other allied health professionals)
研究组 & 干预措施
PIUO Pathway
The PIUO Pathway targets PIUO in an intentional, focused, timely, sequential order of standardized steps to support best outcomes for children with SNI and families.
The PIUO Pathway is comprised of 2 steps. Step 1 is for the pediatrician to conduct a thorough history that includes a pain history to identify known and unknown sources of past and current pain, and a physical examination. Step 2 is to carry out a series of screening tests to further explore any potential underlying disease or injury if not apparent based on the Step 1 history and physical examination. The standard screening tests may include urinalysis, ultrasound, gastric pH, and bloodwork. Each child proceeds through the Pain Pathway as long as their pain persists but may not go through all steps if their pain source is identified or pain resolves at any stage. The Steps of the Pain Pathway may be refined by the team based on the results of Phase 1 study analysis, which is underway.
干预措施: PIUO Pathway (Other)
结局指标
主要结局
Implementation Adoption
时间窗: End of the Pain Pathway, an average of 1 year to 18 months
Adoption of the Pain Pathway will be measured by completion rates, self-reported by community pediatricians.
Implementation Reach
时间窗: Baseline and end of the Pain Pathway, an average of 1 year to 18 months
Reach of the Pain Pathway will be measured by recruitment and retention rates of community pediatricians, self-reported by community pediatricians.
Implementation Acceptability
时间窗: End of the Pain Pathway, an average of 1 year to 18 months
Acceptability of the Pain Pathway will be measured by level of satisfaction (e.g., 1 = very unsatisfied; 7 = very satisfied) based on a Likert scale and self-reported by community pediatricians. Scores will be averaged and higher scores reflect higher levels of satisfaction/acceptability.
PIUO Pain Pathway Effectiveness
时间窗: End of the Pain Pathway, an average of 1 year to 18 months
Effectiveness of the PIUO Pain Pathway will be measured by proportion of children with SNI and families who received appropriate steps of investigation and treatment options based on following the steps of the PIUO Pain Pathway.
次要结局
- Pain and Irritability (PIUO)(Baseline and end of the Pain Pathway, an average of 1 year to 18 months)
- Factors Influencing Implementation(Baseline and end of the Pain Pathway, an average of 1 year to 18 months)
- Family Well-being(Baseline and end of the Pain Pathway, an average of 1 year to 18 months)
研究者
Harold Siden
Clinical Professor
University of British Columbia