Empowering Families of Migrant Children and Youth with Special Healthcare Needs

NCT06373588 | Recruiting

• 1 other identifier: MP-37-2023-9418
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 3

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

Conditions

Patient Navigation

Keywords

Child Health; Chronic health diseases; Patient Navigation; Migrant population; Refugee; Immigrant; Asylum seeker; Culturally competent care; Health services research

Outcome Measures

Primary Outcomes (1)

• Barriers to Care (BCQ)

  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).

  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 (9)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Usual Care

NO INTERVENTION

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.

Patient Navigator

EXPERIMENTAL

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).

Behavioral: Patient Navigator

Interventions

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.

Patient Navigator

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Unity Health Toronto: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• The Hospital for Sick Children: collaborator

Study Sites (3)

Unity Health Toronto, Compass Clinic

Toronto, Ontario, M5B 1W8, Canada

NOT YET RECRUITING

CIUSSS West-Central Montreal

Montreal, Quebec, H3N 1Y9, Canada

RECRUITING

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

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• Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008 Apr;62(1):107-15. doi: 10.1111/j.1365-2648.2007.04569.x.

  PMID: 18352969 BACKGROUND

• Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093/intqhc/mzm042. Epub 2007 Sep 14.

  PMID: 17872937 BACKGROUND

• Impact of the South Asian Adolescent Diabetes Awareness Program (SAADAP) on diabetes knowledge, risk perception and health behaviour.

  BACKGROUND

• Weidman DR, Desmarais P, Stevens K, Klinger CA, Colquhoun H, Bender JL, Gupta A. Peer Support Needs of Adolescents with Cancer in Pediatrics: A Canadian Mixed Methods Study. J Adolesc Young Adult Oncol. 2022 Aug;11(4):433-438. doi: 10.1089/jayao.2021.0122. Epub 2021 Sep 30.

  PMID: 34591689 BACKGROUND

• McKay S. Immigrant Children With Special Health Care Needs: A Review. Curr Probl Pediatr Adolesc Health Care. 2019 Feb;49(2):45-49. doi: 10.1016/j.cppeds.2019.01.004. Epub 2019 Feb 15.

  PMID: 30777710 BACKGROUND

• Merry L, Pelaez S. Knowledge translation and better health and health care for migrants in Canada: What is the responsibility of health funders and researchers? Can Fam Physician. 2021 Jun;67(6):403-405. doi: 10.46747/cfp.6706403. No abstract available.

  PMID: 34127460 BACKGROUND

Related Links

• United States Census Bureau. 2020 National Survey of Children's Health. Accessed December 31, 2021
• Canadian Institutes of Health Research. (2021). Transitions in Care. Retrieved from Government of Canada: Canadian Institutes of Health Research. Accessed December 30, 2022
• Barriers to Health Service Utilization by Immigrant Families Raising a Disabled Child: Unmet Needs and the Role of Discrimination
• Children with an immigrant background: Bridging cultures
• Statistics Canada. Social Assistance Receipt Among Refugee Claimants in Canada
• Social Planning Toronto. Unequal City: The Hidden Divide Among Toronto's Children and Youth
• National Care Coordination Standards for Children and Youth with Special Health Care Needs.
• Guidance on co-producing a research project.
• WHO guidelines on hand hygiene in health care.
• Geographic distribution of immigrants and recent immigrants and their proportion within the population of census metropolitan areas, Canada
• National Newcomer Navigation Network

MeSH Terms

Interventions

Patient Navigation

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Patricia Li

  Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Tachdjian

CONTACT

438-543-2662; melissa.tachdjian@rimuhc.ca

Patricia Li, MD MSc FRCPC

CONTACT

patricia.li@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Pediatrics, Faculty of Medicine and Health Sciences

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: August 13, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)