Patient Navigator for Care Coordination

(MiNav Trial)

Recruiting at 7 trial locations

Overseen By Melissa Tachdjian

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Disqualifiers: Caregiver in Canada ≥10 years, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

324 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether a patient navigator can improve healthcare for migrant families caring for children with special health needs. A patient navigator acts as a guide, helping families understand and access healthcare services. Families will be randomly assigned to either receive assistance from a patient navigator or continue with their usual healthcare for a year. Ideal candidates for this trial are migrant families with children who have ongoing health conditions and frequently move between different healthcare services. As an unphased trial, this study offers families the chance to enhance their healthcare experience through personalized support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on care coordination rather than medication changes.

What prior data suggests that the patient navigator program is safe for improving healthcare experiences and outcomes?

Research has shown that patient navigator programs are generally safe for participants. These programs help people, especially those with long-term health issues, navigate the healthcare system more easily. Studies indicate that patient navigators can improve care organization and facilitate access to healthcare services without causing harm.

Patient navigators often assist with tasks like setting up appointments and connecting with healthcare providers, which participants usually appreciate. No strong evidence of negative effects or problems related to these programs exists. This suggests that the patient navigator approach is well-tolerated and safe for families involved in this type of trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Patient Navigator approach because it offers a personalized touch to care coordination that standard treatments often lack. Unlike traditional care, which can be fragmented and impersonal, this method pairs patients with a dedicated navigator who helps them manage their healthcare journey. These navigators provide ongoing support through various communication channels like in-person visits, video calls, and even SMS, tailoring care plans to individual needs. This hands-on approach aims to improve patient outcomes by ensuring that care is cohesive and responsive to each patient's unique circumstances.

What evidence suggests that the patient navigator program is effective for improving healthcare experiences and outcomes for migrant families with a child or youth with special healthcare needs?

This trial will compare the effects of usual care with the use of a Patient Navigator. Research has shown that patient navigator programs can significantly improve healthcare outcomes. Participants in the Patient Navigator arm will pair with a navigator who will help connect them to local health services, making access to care easier. These programs also enhance coordination among different parts of a patient's healthcare, ensuring smoother operations. Patient navigators can reduce stress for caregivers by guiding them through the healthcare system and empowering them with greater control and understanding of their child's health needs. Overall, patient navigators enhance the healthcare experience for families, particularly those from minority or underserved communities. ^{3 4 5 6 7}

Who Is on the Research Team?

Patricia Li

Principal Investigator

Research Institute of the McGill University Health Centre

Are You a Good Fit for This Trial?

This trial is for migrant families with children or youth who have special healthcare needs, such as chronic health conditions. Participants will be involved in the study for 12 months and must be willing to fill out questionnaires at different times.

Inclusion Criteria

Children or youth with special health care needs as defined by the CYSHCN Screener

I am the main caregiver for a child under 18 who is a first- or second-generation migrant.

I am transitioning between different types of healthcare services.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the patient navigator program or continue with standard care for 12 months

12 months

Initial contact within 7 days, then at least once every 3 months, and as needed

Follow-up

Participants are monitored for healthcare experiences and outcomes after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Patient Navigator

Trial Overview The study is testing a patient navigator program to see if it helps improve healthcare experiences and outcomes by reducing barriers to care, enhancing care coordination, empowering caregivers, alleviating caregiver stress, and improving quality of life.

How Is the Trial Designed?

Group I: Patient Navigator Experimental Treatment 1 Intervention

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).

Group II: Usual Care Active Control 1 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.

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

National Newcomer Navigation Network

Collaborator

Trials

1

Recruited

320+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Montreal Children's Hospital of the MUHC

Collaborator

Trials

32

Recruited

117,000+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Centre for Refugee Children, Toronto

Collaborator

Trials

1

Recruited

320+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Women's College Hospital

Collaborator

Trials

108

Recruited

43,700+

Published Research Related to This Trial

The pilot study involved 75 elderly patients, primarily female, who received patient navigation services from a social worker, helping them effectively navigate the complex US healthcare system.

Patients reported finding the navigation services very helpful, and physicians recognized the PN as a valuable addition to the practice, indicating that integrating patient navigation into primary care can significantly benefit those with complex healthcare needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the patient navigator approach to meet the needs of primary care. Ferrante, JM., Cohen, DJ., Crosson, JC.[2022]

A study involving 1345 patients with abnormal cancer screenings or cancer diagnoses found a significant correlation between satisfaction with patient navigators and overall satisfaction with cancer-related care, indicating that effective navigation can enhance patient experiences.

Factors such as having an abnormal colorectal cancer screening and being older or from a minority racial-ethnic background were linked to higher satisfaction levels, suggesting that tailored navigation support may help address disparities in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction with cancer care among underserved racial-ethnic minorities and lower-income patients receiving patient navigation. Jean-Pierre, P., Cheng, Y., Wells, KJ., et al.[2022]

The Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I) measure was validated in a study involving 783 participants, demonstrating high internal consistency and reliability (α ranging from 0.95 to 0.96).

The PSN-I effectively captures patient satisfaction with navigators, showing strong correlations with existing satisfaction measures, which suggests it is a reliable tool for assessing the quality of support provided to underserved cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric development and reliability analysis of a patient satisfaction with interpersonal relationship with navigator measure: a multi-site patient navigation research program study. Jean-Pierre, P., Fiscella, K., Winters, PC., et al.[2022]

A systematic review of seven studies highlights the effectiveness of oncology nurse practitioner navigators in improving timely care and enhancing patient and staff satisfaction.

The review emphasizes the importance of well-defined metrics for evaluating navigation programs, aligning with expert consensus recommendations, while also calling for more rigorous research tools in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of oncology nurse practitioner navigation metrics. Johnson, F.[2022]

The Patient Care Coordination model empowers nursing leaders to enhance healthcare delivery by reallocating nursing resources to direct patient care, which can lead to improved patient outcomes.

Early results indicate that this model may reduce hospital stays, enhance quality of care, and increase patient satisfaction, suggesting it could significantly transform acute care delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The patient care coordinator role: an innovative delivery model for transforming acute care and improving patient outcomes. Skillings, LN., MacLeod, D.[2019]

The breast cancer navigation (BCN) program significantly improved physician workflows, with many physicians stating it made their day easier and enhanced care coordination and patient experience.

Patients also reported high satisfaction with the support they received during diagnosis communication, indicating that the BCN program effectively met their needs during a challenging time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer Navigation: Using Physician and Patient Surveys to Explore Nurse Navigator Program Experiences. Dillon, EC., Kim, P., Li, M., et al.[2021]

Patient navigation can significantly improve access to care and support for vulnerable cancer patients, particularly those with low income, low education, and multiple health issues, as shown by recent analyses of the Patient Navigation Research Program.

To be most effective, patient navigation programs should be tailored to address the specific challenges faced by these high-risk populations, requiring careful planning and integration into existing healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of evidence-based patient navigation programs. Freund, KM.[2017]

The survey of 819 patient navigators revealed significant differences in their roles and responsibilities based on their type, with nurse navigators more likely to have clinical duties and work in hospital settings, while lay navigators were less involved with underserved populations.

The study highlights the importance of using the Consolidated Framework for Implementation Research (CFIR) to understand how different types of patient navigators impact program implementation and patient outcomes, suggesting that future research should focus on care coordination outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The early dissemination of patient navigation interventions: results of a respondent-driven sample survey. Valverde, PA., Calhoun, E., Esparza, A., et al.[2019]

Oncology nurse navigation programs significantly reduced the time from the first provider visit to the start of therapy for patients with hematologic malignancies, improving access to care.

Patient and provider satisfaction scores were high regarding the navigation program, although it did not lead to an increase in clinical trial enrollment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncology Nurse Navigation: Development and Implementation of a Program at a Comprehensive Cancer Center . Gordils-Perez, J., Schneider, SM., Gabel, M., et al.[2018]

The development of a nurse care coordinator role in oncology aims to enhance patient and family-centered care by providing consistent support and guidance through complex cancer treatments.

This model includes clear role definitions, workflow management tools, and the integration of electronic medical records to improve care coordination and track the effectiveness of the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the Scene: Developing a Nurse Care Coordinator Role at City of Hope. Johnson, SA., Giesie, PD., Ireland, AM., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10165767/

Effectiveness of system navigation programs linking ... This systematic review aims to identify the effectiveness of system navigation programs linking primary care with community-based health and social services.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4121958/

The Role of Patient Navigators in Eliminating Health ... This article explores the unique role that patient navigation can play in improving health outcomes for racial and ethnic minorities, as well as other ...

3. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-021-07140-6

The role of patient navigators in ambulatory care: overview of ... Two reviews on patient navigation in transitional care reported improved patient outcomes, hospital readmission rates and mixed evidence on ...

4. aspe.hhs.gov aspe.hhs.gov/sites/default/files/documents/789434ceda231203f080288de603d1ef/PR-A2599-1.pdf

Exploring Patient Care Navigation in the Medicare Program We then grouped outcomes from data from peer-reviewed literature and reports on the impact of navigation on patients and their families. We did not include ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399116304839

The effectiveness of patient navigation to improve ... Patient navigation is an effective intervention to increase health screening rates. Both lay and professional patient navigators (eg, nurses) can be effective.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK577643/

POLICY BRIEF - What are patient navigators and how ... - NCBI Five systematic reviews reported positive effects of patient navigation on care coordination and continuity of care, including improved referrals, adherence ...

7. patientnavigatortraining.org patientnavigatortraining.org/elearning/wp-content/uploads/2022/10/Care-Coordination-Workbook-with-Tools.pdf

Level 2: Advanced Care Coordination for Patient Navigators This course focuses on the role of the patient navigator in team-based care coordination. A Level 2 patient navigator may be a nurse or social worker with a ...