Patient Navigator Intervention for Migrant Children With Special Healthcare Needs Experiencing Care Transitions

Co-design and Evaluation of a Patient Navigator Intervention for Migrant Children and Youth With Special Healthcare Needs (CYSHCN) Experiencing Care Transitions

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

Study Overview

• Status: Not yet recruiting
• Conditions: Patient Navigation
• Intervention / Treatment: Behavioral: Patient Navigator

• Study Type: Interventional
• Enrollment (Estimated): 324
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa Tachdjian; Phone Number: 514-233-1873; Email: melissa.tachdjian@rimuhc.ca
• Study Contact Backup: Name: Patricia Li, MD MSc FRCPC; Phone Number: 5144124400; Email: patricia.li@mcgill.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • Unity Health Toronto, Compass Clinic
      • Contact: Ahrrabie Thirunavukkarasu; Email: athirun@uwo.ca
      • Principal Investigator: Shazeen Suleman, MD MPH FRCPC
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital, Crossroads Clinic
      • Contact: Xinyang Ye; Email: xinyang.ye@unityhealth.to
      • Principal Investigator: Meb Rashid
  • Quebec
    • Montréal, Quebec, Canada, H4A 3J1
      • Montreal Children's Hospital
      • Contact: Melissa Tachdjian; Phone Number: 514-233-1873; Email: melissa.tachdjian@rimuhc.ca
      • Principal Investigator: Patricia Li
      • Contact: Patricia Li; Phone Number: 438-402-0510; Email: patricia.li@mcgill.ca
    • Montréal, Quebec, Canada, H3N 1Y9
      • CLSC de Parc-Extension
      • Contact: Patricia LI; Email: patricia.li@mcgill.ca
      • Principal Investigator: Patricia Li
      • Sub-Investigator: Juan Carlos Chirgwin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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).	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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective care coordination	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.	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	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.	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	ER visits, hospital admissions, and no-show visits, through chart review and patient reports.	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	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).	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	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.	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)	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.	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	The distress thermometer asks participants their level of distress in the past month on a scale of 0-10, 10 indicating extreme distress.	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	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.	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)	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.	Assessment will happen at 6 months and at the end of the intervention, i.e., 12 months, only for the intervention group.

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: The Hospital for Sick Children; Canadian Institutes of Health Research (CIHR); Unity Health Toronto; Women's College Hospital; Montreal Children's Hospital of the MUHC; National Newcomer Navigation Network; Centre for Refugee Children, Toronto
• Investigators: Principal Investigator: Patricia Li, Research Institute of the McGill University Health Centre

Publications and helpful links

General Publications

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Helpful 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

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Patient Navigation; Health services research; Child Health; Immigrant; Culturally competent care; Refugee; Chronic health diseases; Migrant population; Asylum seeker
• Other Study ID Numbers: MP-37-2023-9418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No