Co-design and Evaluation of a Patient Navigator Intervention for Migrant Children and Youth with Special Healthcare Needs (CYSHCN) Experiencing Care Transitions (MiNav Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 324
- 试验地点
- 6
- 主要终点
- Barriers to Care (BCQ)
研究概览
简要总结
The goal of this randomized controlled trial is to test if a patient navigator program improves healthcare experiences and outcomes for migrant families caring for a child or youth with special healthcare needs (i.e. chronic health condition).
The main questions are, for migrant families with a child or youth with special healthcare needs:
Does a patient navigator reduces barriers to care? Does a patient navigator improve care coordination, caregiver empowerment, caregiver stress and quality of life? What are the healthcare experiences for families with and without the patient navigator intervention?
Participants will:
- Receive the intervention, i.e., the patient navigator program, or continue with standard of care for 12 months
- Fill out questionnaires at 3 time points on barriers to care, caregiver stress, care coordination, and their child's health
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary caregiver of child/youth ≤18 years who is first- or second-generation migrant, defined as born outside of Canada or having parents born elsewhere, respectively (migrants include immigrants, resettled refugees, refugee claimants (asylum seekers), temporary workers or international students, and other individuals without formal immigration status (undocumented)).
- •Children or youth with special health care needs, as defined by the CYSHCN Screener, which identifies children who are experiencing one or more functional limitation or service use due to a physical, emotional, behavioural, developmental, or other health condition that has lasted or is expected to last at least 12 months.
- •Experiencing care transitions between at least 2 of the following: primary care, community-based care, secondary specialist care, and/or hospital-based (acute) care.
排除标准
- •Caregiver living in Canada ≥10 years
- •Families who are receiving available peer navigation support at sites will be excluded to limit cross-over of interventions.
结局指标
主要结局
Barriers to Care (BCQ)
时间窗: Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.
The BCQ has been validated for children and youth with special healthcare needs. It contains 39 items grouped in 5 sub-scales, which include: 1) Pragmatics: issues related to logistics and costs that may prevent or delay appropriate utilization; 2) Skills: strategies to navigate or function competently in health system care; 3) Expectations: caregiver expectations of receiving poor quality care, including a lack of communication between doctors, health care system; 4) Marginalization: the "internationalization and personalization of negative experiences within the health care system"; 5) Knowledge and beliefs: personal ideas about nature and treatment of illness (including culture), which may differ from the healthcare provider. Caregivers rate the items on a 5-point Likert scale, converted to a score ranging from 0 to 100 (higher scores = fewer barriers).
次要结局
- Short-form survey 12(Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.)
- Healthcare utilization(Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.)
- Effective care coordination(Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.)
- Patient Health Questionnaire (PHQ-2)(Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.)
- Patient Satisfaction with Interpersonal Relationships with Navigators (PSN-I)(Assessment will happen at 6 months and at the end of the intervention, i.e., 12 months, only for the intervention group.)
- Parental empowerment scale(Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.)
- PROMIS - Pediatric Global Health 7(Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.)
- Distress Thermometer(Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.)
- Perceived stress scale(Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.)
研究者
Patricia Li
Associate Professor, Department of Pediatrics, Faculty of Medicine and Health Sciences
McGill University Health Centre/Research Institute of the McGill University Health Centre