Empowering Families of Migrant Children and Youth with Special Healthcare Needs

NCT ID: NCT06373588

Last Updated: 2024-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-13

Study Completion Date

2027-08-31

Brief Summary

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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

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Conditions

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Patient Navigation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care

Participants will receive care usually provided within their clinics and a standard package with healthcare resources. In keeping with the pragmatic design, there will be variation in the support provided for navigation and care coordination, referral patterns to health and social services, as well as community resources. However, we will document these differences to provide context about potential differences in effects which may occur between sites.

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Patient Navigator

Intervention Type 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.

Interventions

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Patient Navigator

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Patricia Li

Associate Professor, Department of Pediatrics, Faculty of Medicine and Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patricia Li

Role: PRINCIPAL_INVESTIGATOR

Research Institute of the McGill University Health Centre

Locations

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Unity Health Toronto, Compass Clinic

Toronto, Ontario, Canada

Site Status NOT_YET_RECRUITING

CIUSSS West-Central Montreal

Montreal, Quebec, Canada

Site Status RECRUITING

Montreal Children's Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Melissa Tachdjian

Role: CONTACT

438-543-2662

Patricia Li, MD MSc FRCPC

Role: CONTACT

Facility Contacts

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Ahrrabie Thirunavukkarasu

Role: primary

Shazeen Suleman, MD MPH FRCPC

Role: backup

Melissa Tachdjian

Role: primary

(438) 543-2662

Patricia Li

Role: backup

Juan Carlos Chirgwin

Role: backup

Melissa Tachdjian

Role: primary

438-543-2662

Patricia Li

Role: backup

Patricia Li

Role: backup

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Related Links

Access external resources that provide additional context or updates about the study.

https://www2.census.gov/programs-surveys/nsch/technical-documentation/codebook/NSCH_2020_Screener_Frequencies.pdf

United States Census Bureau. 2020 National Survey of Children's Health. Accessed December 31, 2021

https://cihr-irsc.gc.ca/e/50972.html

Canadian Institutes of Health Research. (2021). Transitions in Care. Retrieved from Government of Canada: Canadian Institutes of Health Research. Accessed December 30, 2022

http://p2pcanada.ca/wp-content/uploads/2011/09/families-with-disabled-child-final-report1.pdf

Barriers to Health Service Utilization by Immigrant Families Raising a Disabled Child: Unmet Needs and the Role of Discrimination

http://www150.statcan.gc.ca/n1/pub/11-626-x/11-626-x2015051-eng.htm

Statistics Canada. Social Assistance Receipt Among Refugee Claimants in Canada

http://www.socialplanningtoronto.org/unequal_city_the_hidden_divide_among_toronto_s_children_and_youth

Social Planning Toronto. Unequal City: The Hidden Divide Among Toronto's Children and Youth

http://www.nashp.org/wp-content/uploads/2020/10/care-coordination-report-v5.pdf

National Care Coordination Standards for Children and Youth with Special Health Care Needs.

http://www150.statcan.gc.ca/n1/daily-quotidien/171025/t001b-eng.htm#fn02

Geographic distribution of immigrants and recent immigrants and their proportion within the population of census metropolitan areas, Canada

http://www.newcomernavigation.ca/en/index.aspx

National Newcomer Navigation Network

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MP-37-2023-9418

Identifier Type: -

Identifier Source: org_study_id

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