Patient NavigationMiNavNCT06373588
Empowering Families of Migrant Children and Youth with Special Healthcare Needs
A study testing Patient Navigator in people with Patient Navigation, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Patient Navigation
- What is being tested?
- Patient Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 3 sitesCanada
- Study dates
- 13 Aug 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Patricia Li, MD MSc FRCPC contact
Canada3 sites, 3 recruiting
- Recruiting
CIUSSS West-Central Montreal
Montreal, Quebec, H3N 1Y9
Melissa Tachdjian, (438) 543-2662, navigation@muhc.mcgill.ca
Patricia Li
- Recruiting
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
Melissa Tachdjian, 438-543-2662, navigation@muhc.mcgill.ca
Patricia Li, patricia.li@mcgill.ca
- Not yet recruiting
Unity Health Toronto, Compass Clinic
Toronto, Ontario, M5B 1W8
Ahrrabie Thirunavukkarasu, ahrrabie.thirunavukkarasu@unityhealth.to
Shazeen Suleman, MD MPH FRCPC
About this study
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)
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:
Read more
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
- Being tested
- Patient Navigator
- Keywords
- Child Health, Chronic health diseases, Patient Navigation, Migrant population, Refugee, Immigrant, Asylum seeker, Culturally competent care, Health services research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigatorBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Patient Navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessment will happen at 6 months and at the end of the intervention, i.e., 12 months, only for the intervention group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start13 Aug 2024
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (81)Papers the sponsor has linked to this study.
- Other trials for Patient NavigationStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto, Canadian Institutes of Health Research (CIHR), The Hospital for Sick Children
- Responsible party
- Principal investigator, Patricia Li, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Patricia Li, Principal investigator, Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373588
- Sponsor's protocol ID
- MP-37-2023-9418
- Acronym
- MiNav
- Status last verified
- Jul 2024
- First submitted
- 15 Apr 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 9714637Arim 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.
PubMed 25692939Antonelli 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.
PubMed 29932000Fox 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.
PubMed 27858263Khanlou 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.
PubMed 25376126Alsharaydeh 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.
PubMed 31637861Yu 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.
PubMed 19948607Son E, Moring NS, Igdalsky L, Parish SL. Navigating the health-care system in community: Perspectives from Asian immigrant parents of children with special health-care needs. J Child Health Care. 2018 Jun;22(2):251-268. doi: 10.1177/1367493517753084. Epub 2018 Jan 28.
PubMed 29374977Kalich A, Heinemann L, Ghahari S. A Scoping Review of Immigrant Experience of Health Care Access Barriers in Canada. J Immigr Minor Health. 2016 Jun;18(3):697-709. doi: 10.1007/s10903-015-0237-6.
PubMed 26093784Salami B, Mason A, Salma J, Yohani S, Amin M, Okeke-Ihejirika P, Ladha T. Access to Healthcare for Immigrant Children in Canada. Int J Environ Res Public Health. 2020 May 10;17(9):3320. doi: 10.3390/ijerph17093320.
PubMed 32397618Ahmed S, Shommu NS, Rumana N, Barron GR, Wicklum S, Turin TC. Barriers to Access of Primary Healthcare by Immigrant Populations in Canada: A Literature Review. J Immigr Minor Health. 2016 Dec;18(6):1522-1540. doi: 10.1007/s10903-015-0276-z.
PubMed 26364053McKeary M, Newbold B. Barriers to care: the challenges for Canadian refugees and their health care providers. Journal of Refugee Studies. 2010;23(4):523-545.
Campbell RM, Klei AG, Hodges BD, Fisman D, Kitto S. A comparison of health access between permanent residents, undocumented immigrants and refugee claimants in Toronto, Canada. J Immigr Minor Health. 2014 Feb;16(1):165-76. doi: 10.1007/s10903-012-9740-1.
PubMed 23124632Woodgate RL, Busolo DS, Crockett M, Dean RA, Amaladas MR, Plourde PJ. A qualitative study on African immigrant and refugee families' experiences of accessing primary health care services in Manitoba, Canada: it's not easy! Int J Equity Health. 2017 Jan 9;16(1):5. doi: 10.1186/s12939-016-0510-x.
PubMed 28068998
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06373588
- Acronym / sponsor ID
- MiNav / MP-37-2023-9418
- Conditions
- Patient Navigation
- Keywords
- Child Health, Chronic health diseases, Patient Navigation, Migrant population, Refugee, Immigrant, Asylum seeker, Culturally competent care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Unity Health Toronto, Canadian Institutes of Health Research (CIHR), The Hospital for Sick Children
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Patient NavigatorParticipants 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). |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient NavigatorThe 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. | Behavioural | Patient Navigator |
Primary outcome
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.
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).
9 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Background: PubMed 9714637McPherson 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.
- Background: PubMed 25692939Arim 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.
- BackgroundAntonelli R, McAllister J, Popp J. Making Care Coordination a Critical Component of the Pediatric Health System: A Multidisciplinary Framework. 2009.
- Background: PubMed 29932000Cordeiro 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.
- Background: PubMed 27858263Fox 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.
- Background: PubMed 25376126Khanlou 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.
- Background: PubMed 31637861Alsharaydeh 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.
- Background: PubMed 19948607Yu 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.
- Background: PubMed 29374977Son E, Moring NS, Igdalsky L, Parish SL. Navigating the health-care system in community: Perspectives from Asian immigrant parents of children with special health-care needs. J Child Health Care. 2018 Jun;22(2):251-268. doi: 10.1177/1367493517753084. Epub 2018 Jan 28.
- Background: PubMed 26093784Kalich A, Heinemann L, Ghahari S. A Scoping Review of Immigrant Experience of Health Care Access Barriers in Canada. J Immigr Minor Health. 2016 Jun;18(3):697-709. doi: 10.1007/s10903-015-0237-6.
- Background: PubMed 32397618Salami B, Mason A, Salma J, Yohani S, Amin M, Okeke-Ihejirika P, Ladha T. Access to Healthcare for Immigrant Children in Canada. Int J Environ Res Public Health. 2020 May 10;17(9):3320. doi: 10.3390/ijerph17093320.
- Background: PubMed 26364053Ahmed S, Shommu NS, Rumana N, Barron GR, Wicklum S, Turin TC. Barriers to Access of Primary Healthcare by Immigrant Populations in Canada: A Literature Review. J Immigr Minor Health. 2016 Dec;18(6):1522-1540. doi: 10.1007/s10903-015-0276-z.
- United States Census Bureau. 2020 National Survey of Children's Health. Accessed December 31, 2021Link provided by the sponsor.
- Canadian Institutes of Health Research. (2021). Transitions in Care. Retrieved from Government of Canada: Canadian Institutes of Health Research. Accessed December 30, 2022Link provided by the sponsor.
- Children with an immigrant background: Bridging culturesLink provided by the sponsor.
- Statistics Canada. Social Assistance Receipt Among Refugee Claimants in CanadaLink provided by the sponsor.
- Social Planning Toronto. Unequal City: The Hidden Divide Among Toronto's Children and YouthLink provided by the sponsor.
- National Care Coordination Standards for Children and Youth with Special Health Care Needs.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Patient Navigation
Not yet recruiting
Patient-reported Outcomes-driven Supportive Care Navigation Among Hispanic/Latinx Cancer Patients
Cancer
Not yet recruiting
A Patient Navigation Trial for Housing and Health (PATHH)
Housing Instability, Health and Social Services
Active, not recruiting
An Education and Navigation Support Tool to Improve Participation in Care Coordination Among Patients With Locally Advanced, Metastatic and Unresectable Bladder Cancer and Their Caregivers
Locally Advanced Bladder Carcinoma, Metastatic Bladder Carcinoma
Not yet recruiting
Multi-level Intervention to Successfully Transition to Adult Care for Survivors of Childhood and Adolescent Cancers: The BRIDGES-YAS! Study
Health Care Transition, Survivorship Care
Recruiting
Targeted Navigation in Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma, Cholangiocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patricia Li, MD MSc FRCPC contact
Patricia Li principal investigator
Research Institute of the McGill University Health Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigator in people with Patient Navigation, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Tachdjian (438-543-2662, melissa.tachdjian@rimuhc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06373588, which also lists 81 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.