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NCT Number: NCT06373588

Empowering Families of Migrant Children and Youth with Special Healthcare Needs

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

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Key information

Conditions

Patient Navigation

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unity Health Toronto, Compass Clinic, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient Navigator

Behavioral

The patient navigator will meet the following requirements: a bachelor's degree in health or social sciences, or equivalent experiences; strong knowledge of the local health and social services system; trauma-informed care and cultural safety; strong interpersonal skills, ability to problem-solve, and autonomy; have prior experiences with migrant communities (including lived experiences) and working in healthcare setting. The navigator will be trained on topics related to their role, through case discussions, and role playing, as done in other navigator trials. Topics will include Indigenous cultural safety as applied to migrant health, systems navigation, care coordination, family-centred care, social determinants of health (health insurance, income supplements, etc.) and inequities, advanced communication and helping skills (e.g., motivational interviewing), ethics, privacy, and confidentiality, and others as determined through our co-design process.

Primary outcomes

  1. 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

  1. Effective care coordination

    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.

    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.

  2. Parental empowerment scale

    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.

    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.

  3. Healthcare utilization

    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.

    ER visits, hospital admissions, and no-show visits, through chart review and patient reports.

  4. PROMIS - Pediatric Global Health 7

    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.

    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).

  5. Short-form survey 12

    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.

    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.

  6. Patient Health Questionnaire (PHQ-2)

    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.

    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.

  7. Distress Thermometer

    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 distress thermometer asks participants their level of distress in the past month on a scale of 0-10, 10 indicating extreme distress.

  8. Perceived stress scale

    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.

    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.

  9. Patient Satisfaction with Interpersonal Relationships with Navigators (PSN-I)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa Tachdjian

CONTACT

[email protected]

438-543-2662

Patricia Li, MD MSc FRCPC

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • The Hospital for Sick Children
  • Unity Health Toronto

Registry information

Official study 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)

Acronym: MiNav

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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