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Clinical Trials/NCT06373588
NCT06373588
Not Yet Recruiting
N/A

Co-design and Evaluation of a Patient Navigator Intervention for Migrant Children and Youth With Special Healthcare Needs (CYSHCN) Experiencing Care Transitions (MiNav Trial)

McGill University Health Centre/Research Institute of the McGill University Health Centre3 sites in 1 country324 target enrollmentAugust 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Patient Navigation
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment
324
Locations
3
Primary Endpoint
Barriers to Care (BCQ)
Status
Not Yet Recruiting
Last Updated
last year

Overview

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
Registry
clinicaltrials.gov
Start Date
August 1, 2024
End Date
August 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible Party
Principal Investigator
Principal Investigator

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

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Barriers to Care (BCQ)

Time Frame: 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 Outcomes

  • 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.)

Study Sites (3)

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