protocolSection identificationModule nctId: NCT06373588, orgStudyIdInfo id: MP-37-2023-9418, briefTitle: Patient Navigator Intervention for Migrant Children With Special Healthcare Needs Experiencing Care Transitions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), collaborators name: Montreal Children's Hospital of the MUHC, collaborators name: Unity Health Toronto, collaborators name: The Hospital for Sick Children, collaborators name: Women's College Hospital, collaborators name: National Newcomer Navigation Network, collaborators name: Centre for Refugee Children, Toronto, descriptionModule briefSummary: 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, conditionsModule conditions: Patient Navigation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 324, type: ESTIMATED, armsInterventionsModule interventions name: Patient Navigator, outcomesModule primaryOutcomes measure: Barriers to Care (BCQ), secondaryOutcomes measure: Effective care coordination, secondaryOutcomes measure: Parental empowerment scale, secondaryOutcomes measure: Healthcare utilization, secondaryOutcomes measure: PROMIS - Pediatric Global Health 7, secondaryOutcomes measure: Short-form survey 12, secondaryOutcomes measure: Patient Health Questionnaire (PHQ-2), secondaryOutcomes measure: Distress Thermometer, secondaryOutcomes measure: Perceived stress scale, secondaryOutcomes measure: Patient Satisfaction with Interpersonal Relationships with Navigators (PSN-I), eligibilityModule sex: ALL, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Unity Health Toronto, Compass Clinic, city: Toronto, state: Ontario, zip: M5B 1W8, country: Canada, contacts name: Ahrrabie Thirunavukkarasu, role: CONTACT, email: athirun@uwo.ca, contacts name: Shazeen Suleman, MD MPH FRCPC, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Women's College Hospital, Crossroads Clinic, city: Toronto, state: Ontario, zip: M5S 1B2, country: Canada, contacts name: Xinyang Ye, role: CONTACT, email: xinyang.ye@unityhealth.to, contacts name: Meb Rashid, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, locations facility: CLSC de Parc-Extension, city: Montréal, state: Quebec, zip: H3N 1Y9, country: Canada, contacts name: Patricia LI, role: CONTACT, email: patricia.li@mcgill.ca, contacts name: Patricia Li, role: PRINCIPAL_INVESTIGATOR, contacts name: Juan Carlos Chirgwin, role: SUB_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Montreal Children's Hospital, city: Montréal, state: Quebec, zip: H4A 3J1, country: Canada, contacts name: Melissa Tachdjian, role: CONTACT, phone: 514-233-1873, email: melissa.tachdjian@rimuhc.ca, contacts name: Patricia Li, role: CONTACT, phone: 438-402-0510, email: patricia.li@mcgill.ca, contacts name: Patricia Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False