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)

Overview

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

Interventions

• Behavioral 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 cas

Primary outcome measures

• 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.]

Secondary outcome measures (9)

• 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.]
• 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.]
• 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.]
• 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.]
• 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.]
• 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.]
• 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.]
• 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.]
• 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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Canada · 3 centers

• Unity Health Toronto, Compass Clinic — Toronto
• CIUSSS West-Central Montreal — Montreal
• Montreal Children's Hospital — Montreal

Publications

• McPherson M, Arango P, Fox H, Lauver C, McManus M, Newacheck PW, Perrin JM, Shonkoff JP, Strickland B. A new definition of children with special health care needs. Pediatrics. 1998 Jul;102(1 Pt 1):137-40. doi: 10.1542/peds.102.1.137. No abstract available. PMID 9714637
• Arim RG, Kohen DE, Brehaut JC, Guevremont A, Garner RE, Miller AR, McGrail K, Brownell M, Lach LM, Rosenbaum PL. Developing a non-categorical measure of child health using administrative data. Health Rep. 2015 Feb;26(2):9-16. PMID 25692939
• Antonelli R, McAllister J, Popp J. Making Care Coordination a Critical Component of the Pediatric Health System: A Multidisciplinary Framework. 2009.
• Cordeiro A, Davis RK, Antonelli R, Rosenberg H, Kim J, Berhane Z, Turchi R. Care Coordination for Children and Youth With Special Health Care Needs: National Survey Results. Clin Pediatr (Phila). 2018 Oct;57(12):1398-1408. doi: 10.1177/0009922818783501. Epub 2018 Jun 22. PMID 29932000
• Fox F, Aabe N, Turner K, Redwood S, Rai D. "It was like walking without knowing where I was going": A Qualitative Study of Autism in a UK Somali Migrant Community. J Autism Dev Disord. 2017 Feb;47(2):305-315. doi: 10.1007/s10803-016-2952-9. PMID 27858263
• Khanlou N, Haque N, Sheehan S, Jones G. "It is an Issue of not Knowing Where to Go": Service Providers' Perspectives on Challenges in Accessing Social Support and Services by Immigrant Mothers of Children with Disabilities. J Immigr Minor Health. 2015 Dec;17(6):1840-7. doi: 10.1007/s10903-014-0122-8. PMID 25376126
• Alsharaydeh EA, Alqudah M, Lee RLT, Chan SW. Challenges, Coping, and Resilience Among Immigrant Parents Caring for a Child With a Disability: An Integrative Review. J Nurs Scholarsh. 2019 Nov;51(6):670-679. doi: 10.1111/jnu.12522. Epub 2019 Oct 21. PMID 31637861
• Yu SM, Singh GK. Household language use and health care access, unmet need, and family impact among CSHCN. Pediatrics. 2009 Dec;124 Suppl 4:S414-9. doi: 10.1542/peds.2009-1255M. PMID 19948607

Identifiers

NCT: NCT06373588 · MP-37-2023-9418

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗