Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06443190 |
| Other study ID # |
Pro00138085 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2024 |
| Est. completion date |
December 2026 |
Study information
| Verified date |
May 2024 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The objective of this pathway is to establish and evaluate a novel Indigenous-led patient
navigator (IPN) program for Indigenous adolescents living with chronic health conditions in
Maskwacis, Alberta. Over the last three years a community-based participatory research
partnership was developed with Elders and community members from Maskwacis, Maskwacis Health
Services, and researchers from the University of Alberta. Previous research identified the
need for an IPN to support Indigenous young adults and their caregivers in managing their
health conditions transitioning into adulthood and transferring from pediatric to adult
healthcare. The aim of partnership now is to evaluate whether a community-derived IPN program
co-designed with an established group of Maskwacis Elders, Knowledge Keepers, healthcare
providers, caregivers and youth with lived experience can aid in improving the experience of
transitioning into adult healthcare services for Indigenous youth and their families living
in Maskwacis, Alberta.
Description:
Purpose: to implement and evaluate a novel Indigenous Patient Navigator (IPN) pathway for
Indigenous young adults with complex and chronic medical conditions, and their families,
living in Maskwacis, AB learning to manage their health condition transitioning into
adulthood.
Hypothesis: the Indigenous-Led Pathway for Young Adults will provide substantial benefits to
youth and families, including but not limited to cultural ceremony and Elder-support,
emotional support, accessing medical appointments and preventing loss to follow-up, feeling
engaged with the adult health care system, developing self-management and self-advocacy
skills, and reducing feelings of anxiety and isolation. The investigators expect the pathway
will improve the health of Indigenous adolescents and young adults living with chronic health
conditions in Maskwacîs, ultimately improving the wellbeing of the entire community.
Justification: The investigators' previous research has identified key barriers to care
included finances (e.g., cost and availability of transportation to healthcare appointments),
intergenerational trauma making it difficult to prioritize the health condition, racism and
discrimination in health care settings, lack of cultural safety, and loss of benefits at age
18 (e.g., Jordan's Principle does not apply to young adults). Facilitating factors identified
include family support and culture, peer support networks, health condition education, and
having safe spaces in healthcare settings where Indigenous imagery and medicines were visibly
displayed.
During a series of in-person meetings with our Community Advisory Committee (CAC) the
Investigators discussed study findings and possible strategies to address them. The Elders
and Knowledge Keepers concluded that a community-based, Indigenous-led patient navigator
service would be a logical approach to helping transition-age youth navigate the healthcare
system between pediatric and adult care. It was felt that both the barriers and facilitators
summarized above provided evidence for the need for an IPN, and that an IPN could help
mitigate some of the social determinants of health that prevent adolescents and young adults
from attending medical appointments, filling prescriptions, and managing their health
condition(s). IPN programs in Canada exist in acute care settings, children's hospitals,
cancer care, and adult outpatient settings. To the Investigators' knowledge, a community
based IPN program focusing on transition age youth does not yet exist in Canada.
Objectives
1. To strengthen the existing partnership with the CAC and Maskwacis Health Services,
through regular gatherings, engaging in ceremony and traditions, respecting cultural
protocol, encouraging feedback, and ensuring our committee members guide the project's
activities to benefit the community in a good way.
2. To co-design and implement a novel IPN service for Indigenous adolescents with special
health care needs residing in Maskwacis through community engagement sessions and
meetings with senior management of Maskwacis Health Services and Alberta Health
Services.
3. To evaluate the IPN service, addressing the following questions:
1. How do Indigenous youth transitioning into adult care describe their experiences of
transitioning, the role of the IPN in helping them through this transition, and the
impact of the IPN program on the Indigenous perspective of health and wellness?
2. How can these findings promote improved outcomes for Indigenous youth in
transition?
4. To create sustainability of the IPN role within the Maskwacis community and enable the
creation of an IPN program for transition-age youth in other Indigenous communities in
Alberta, both on- and off-reserve.
Research Method/Procedures
Study design and setting: Qualitative study to evaluate an IPN program using a
community-based participatory action research approach. The study will be conducted with and
within the community of Maskwacis, Alberta, Maskwacis Health Services and the Awasisak
Indigenous Health Program at the Stollery Children's Hospital. Maskwacis is located
approximately 90 km southeast of Edmonton. It has a population of ~18 000 residents divided
among Four Nations (Samson, Louis Bull, Ermineskin, Montana) and a small satellite location
in Pigeon Lake.
Participant Recruitment: The CAC and community members will assist Investigators to find ways
to recruit participants from the community. A community-based research assistant (RA) will
approach potentially eligible participants at participating recruitment clinics.
IPN Role: The IPN role will be co-designed and implemented based on thorough community
engagement including the CAC, Alberta Health Services and Maskwacis Health Services. Allowing
flexibility within the role and developing the IPN role with guidance from the CAC and
community will allow the IPN to serve participants, families and the community in the most
appropriate and effective way.
Below is a list of supports that may potentially be provided to participants by the IPN:
1. Connect participants with community supports including housing, social assistance,
disability payments, education, and employment opportunities.
2. Connect participants with cultural resources: cultural programming and events, ceremony,
connection with Elders.
3. Scheduling primary care and/or specialty care appointments as appropriate to address
specific medical/mental health needs.
4. Accessing transportation to medical and social service appointments.
5. Providing in person support and advocacy for participants during health care
appointments.
6. Work with the participant to create a smart phone-based health passport containing key
information about their health condition, names and doses of medications, schedule of
upcoming appointments, and contact names, phone number and addresses for their doctors,
nurses, and allied health professionals. For participants not having access to a
smartphone, this information will be provided on a wallet-sized card.
7. Support adherence to follow-up clinic visits and health maintenance including completing
clinically indicated laboratory tests and obtaining prescription refills as needed.
8. Assist with financial and insurance paperwork (e.g., Jordan's Principal, Non-Insured
Health Benefits, Alberta Income for the Severely Handicapped).
9. Promote self-management skills by providing tools, educational resources, and coaching.
10. Facilitate in-person group sessions open to all participants at a community hall. Group
sessions reduce isolation, empower youth to build connections, advocate for themselves
and each other, and incorporate Indigenous cultural ceremonies.
Navigators will use electronic technology (cell phone, email, text message, social media) to
maintain contact and provide support for participants. The needs of each participant will
vary and hence the program will be participant and family-centered and specific. There will
be no a priori limits on the frequency of contact between the navigator and participant;
contact may be as frequent as daily, or as infrequently as every 2 months at a minimum,
depending on participants' needs.
Health Information Access + Documentation:
Participants will be asked for permission for the research team and IPN to review their
health information within their Electronic Medical Record within Alberta Health Services and
Maskwacis Health Services databases, so the IPN can understand their health condition and how
they use the health care system during this transition. The IPN will record every contact and
nature of assistance provided using the AHS EMR Connect Care, in a standardized encounter
format.
IPN training: Plan for an Indigenous identifying individual who has a minimum of a Bachelor
of Social Work or a Bachelor of Science in Nursing, and experience working with adolescents
and/or young adults in a community setting. The IPN will be trained by a) other IPNs in
Alberta (e.g., Four Winds Program, led by team member Dr. Oster), b) staff at the Awasisak
Indigenous Health Program at the Stollery with AHS onboarding and orientation as
appropriately determined by the reporting manager, c) a non-Indigenous patient navigator at
the Stollery, affiliated with the Transition Navigator Trial led by team member Dr. Mackie,
and d) staff at Maskwacis Health Services. The IPN will receive privacy and confidentiality
training as per TCPS-2, as well as AHS Privacy and Confidentiality Training. Most
importantly, the IPN will be continually involved with the team's CAC to receive guidance and
feedback on the IPN role and implementation and engage in ceremony.
Study Logistics:
1. Navigator Meeting: The IPN will schedule a face-to-face meeting with the participant, or
with caregiver(s) if the participant has developmental delay precluding their
participation independent of a caregiver, or both. Prior to the meeting the IPN will
review the electronic medical record of the youth participant to understand their health
condition and access of healthcare. During this meeting the IPN will complete an
assessment of the participant's healthcare needs and learn about the participant's
journey with their health condition, as well as build trust and rapport with the family.
Using the information from both the interview, as well as from review of their
electronic medical record, the navigator will create an individual-centered transition
plan, in collaboration with the participant, caregiver(s), and if needed with community
partners.
2. Navigator support: Participants will then work with the IPN for up to 18 months. Support
offered by the IPN is previously described under "IPN Role".
3. Peer Support Sessions + Talking Circles: The IPN will organize peer support sessions for
study participants held every 3 months in-person in Maskwacis. Both youth participants
and caregiver participants are invited to take part in peer support sessions. The
purpose of these sessions will be to build a sense of community for youth living with
chronic health conditions and their caregivers, reduce isolation, and empower
participants to develop self-management and self-advocacy skills together in an engaging
and fun environment. Life skills topics such as budgeting and job interviewing will be
included. A community Elder will attend the peer sessions to provide cultural ceremony
and share traditional teachings such as smudging and prayer. During the sessions talking
circles will be offered for participants to engage in discussion with Elders and each
other regarding their experience working with the IPN. Participants may attend as many
or as little of the peer support sessions as they wish.
4. Exit Interview: Participants will complete a follow-up semi-structured interview, held
either in-person or virtually, conducted by the RA to ask about their experience
receiving IPN support. Feedback will be elicited on what aspects of IPN support was
helpful and what could be improved upon. Healthcare providers who work at clinic sites
where recruitment took place will also be asked to take part in an individual interview
about how the IPN service impacted their practice and care provision to Indigenous youth
and their families.
