Empowering Families of Migrant Children and Youth With Special Healthcare Needs
- Conditions
- Patient Navigation
- Interventions
- Behavioral: Patient Navigator
- Registration Number
- NCT06373588
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 324
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patient Navigator Patient Navigator Participants will be paired with a patient navigator. The patient navigator will contact participants: 1) Within 7 days of randomization; 2) At least once every 3 months up to 12 months; 3) As needed to follow-up on tasks identified in previous visits; and 4) As initiated by the participant. Contacts will occur during in-person clinic visits (prioritized for first encounter, if possible), or over video, telephone, SMS, and/or emails. The navigator will tailor the topics addressed during these interactions according to the needs of the participant and compile a care plan with input from the patient, family, and clinicians. In addition, to assess intervention fidelity, patient navigators will document all participant contacts on standardized forms, including topics addressed, services and coordination provided, written care plan provided, and concurrent resources/interventions accessed (e.g., social worker, funding/housing applications, support from community organizations).
- Primary Outcome Measures
Name Time Method Barriers to Care (BCQ) 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).
- Secondary Outcome Measures
Name Time Method 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. For caregivers; This is a self-reported outcome measure that measures quality of life. This one question is scored from 1 poor health - 4 excellent health.
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. ER visits, hospital admissions, and no-show visits, through chart review and patient reports.
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. Based on 6 questions from the National Survey on children with special health care needs, as care coordination that is adequate (receiving help and satisfied), inadequate (not receiving and less than very satisfied), or no need for care coordination.
The primary goals of this survey is to assess the impact of special health care needs and to evaluate change over time.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. For caregivers; The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past two weeks. This questionnaire is used to screen for depression in a "first-step" approach. The PHQ-2 score ranges from 0-6 with a score higher than 3 indicating a likelihood of depression.
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. A valid and reliable measure of satisfaction with patient navigators that contains 9-item answered with a 5-point Likert scale. Score ranging from 1- 45, higher score reflects higher satisfaction with patient navigator.
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. A validated scale in families with children or youth with special healthcare needs. We will use the 12-item "Service System" subscale, which measures empowerment using a 5-point Likert scale converted to a score ranging from 1- 70 (higher scores = increased services) as it pertains to the caregiver actively working to get the services required for their child.
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. Parent-reported assessment of their child's perceived health, quality of life and physical/mental health using a 5-point likert scale. Converted to a score ranging from 1 to 20 (higher scores = better perceived health).
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. The distress thermometer asks participants their level of distress in the past month on a scale of 0-10, 10 indicating extreme distress.
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. 10-item scale designed to help measure individual stress levels in various situations. PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Trial Locations
- Locations (3)
CIUSSS West-Central Montreal
🇨🇦Montréal, Quebec, Canada
Montreal Children's Hospital
🇨🇦Montréal, Quebec, Canada
Unity Health Toronto, Compass Clinic
🇨🇦Toronto, Ontario, Canada