Clinical trial NCT06373588: Empowering Families of Migrant Children and Youth with Special Healthcare Needs
Official title: Co-design and Evaluation of a Patient Navigator Intervention for Migrant Children and Youth with Special Healthcare Needs (CYSHCN) Experiencing Care Transitions (MiNav Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patient Navigation
Keywords: Child Health
Chronic health diseases
Patient Navigation
Migrant population
Refugee
Immigrant
Asylum seeker
Culturally competent care
Health services research
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
name: Canadian Institutes of Health Research (CIHR)
name: The Hospital for Sick Children
First posted: 2024-04-18
Enrollment: 324
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-centre, pragmatic, assessor-blinded, parallel randomized controlled trial with an embedded qualitative study. In the control arm, participants will receive a standard information package and care usually provided within their clinics. In the intervention arm, participants will receive support from a trained 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. 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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


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.

Primary outcomes:
measure: Barriers to Care (BCQ)
timeFrame: Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.
Secondary outcomes:
measure: Effective care coordination
timeFrame: Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.
measure: Parental empowerment scale
timeFrame: Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.
measure: Healthcare utilization
timeFrame: Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.
measure: PROMIS - Pediatric Global Health 7
timeFrame: Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.
measure: Short-form survey 12
timeFrame: Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.
measure: Patient Health Questionnaire (PHQ-2)
timeFrame: Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.
measure: Distress Thermometer
timeFrame: Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.
measure: Perceived stress scale
timeFrame: Assessment will happen at baseline, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.
measure: Patient Satisfaction with Interpersonal Relationships with Navigators (PSN-I)
timeFrame: Assessment will happen at 6 months and at the end of the intervention, i.e., 12 months, only for the intervention group.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Unity Health Toronto, Compass Clinic
state: Ontario
city: Montréal
country: Canada
facility: CIUSSS West-Central Montreal
state: Quebec
city: Montréal
country: Canada
facility: Montreal Children&#39;s Hospital
state: Quebec
Study officials:
affiliation: Research Institute of the McGill University Health Centre
name: Patricia Li
role: PRINCIPAL_INVESTIGATOR
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