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Assessing the Natural Helper approach to culturally responsive healthcare for culturally and linguistically diverse (CALD) individuals with chronic health conditions

The Natural Helper approach to culturally responsive healthcare: A type 1 effectiveness-implementation cluster randomised trial of the effect of a cultural mentor program on patient activation in culturally and linguistically diverse (CALD) patients with chronic diseases.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000697785
Enrollment
242
Registered
2022-05-13
Start date
2023-08-10
Completion date
2025-01-01
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project will explore the effectiveness of a cultural navigator or ‘Natural Helper’ mentoring intervention. The purpose is to understand if patients from culturally and linguistically diverse (CALD) backgrounds experience greater activation when they receive mentoring from a cultural mentor, compared to those who do not receive this mentoring. Who is it for? You may be eligible for this study if you are aged 18 or older, you are commencing active treatment with one of the participating clinics for a specified condition of interest, and you self-identify with a CALD community of interest for cultural mentoring by the clinic they are attending. People who are currently undergoing treatment for their cancer or who have recently completed cancer treatment may be eligible for this study. Study details Participants who choose to enrol in this study will be randomly allocated (by chance, similar to flipping a coin) to either immediate mentoring after enrolment, or delayed access to mentoring (approximately 9 months post-enrolment). This allocation will occur at the clinic level, so all participants who are attending the same clinic will either receive immediate mentoring or delayed mentoring depending upon their clinic's allocation. In the immediate mentoring clinics, participants will be paired up with a Natural Helper mentor who will have a lived-experience of the same chronic disease. Mentors will use a range of techniques associated with promoting behaviour change and chronic disease self-management. Advice provided by mentors will be grounded in their own experience with chronic disease self-management. Participants will be asked to attend a minimum of 3 sessions with their mentor over a 3 month period. If they wish to, participants can continue to meet with their mentor after this time. The delayed mentoring clinics will not have any natural helper mentors available for the first 9 months but participants attending these clinics will be able to access standard care services as provided by the clinics. After 9 months, these delayed clinics will then undertake the mentoring program as outlined above. It is hoped this research will determine whether having a mentor with similar life experiences a mentor can result in better outcomes for patient engagement with treatment, coping, self-efficacy and health-related quality of life.

Interventions

As a hybrid effectiveness-implementation trial the intervention is described in terms of the clinical intervention (cultural mentoring alongside routine care) and the implementation strategies. 1) Clinical intervention: The mentoring provided by cultural mentors (termed ‘natural helpers’) will constitute the intervention provided alongside routine care. In this specific project, the mentors are volunteer ‘Natural Helpers’, defined as community members who are intrinsically motivated to help o

As a hybrid effectiveness-implementation trial the intervention is described in terms of the clinical intervention (cultural mentoring alongside routine care) and the implementation strategies. 1) Clinical intervention: The mentoring provided by cultural mentors (termed ‘natural helpers’) will constitute the intervention provided alongside routine care. In this specific project, the mentors are volunteer ‘Natural Helpers’, defined as community members who are intrinsically motivated to help others in everyday life. Natural Helper mentors will have a lived-experience of chronic disease and will be recruited from participating health services Previous volunteer and/or mentoring experience is not a pre-requisite and they will be upskilled using a training package that has been developed specifically for this project via a co-design process with consumers and multicultural health experts and refined following pilot testing. The training package will include 16 hours of training encompassing mandatory site requirements, discussion of roles aligned with Dennis’ conceptual model of peer mentoring (1), mentoring content and behaviour change techniques (outlined below) and practical application (utilise role plays/simulations). Training sessions are anticipated to be delivered in hybrid format (face to face and virtual), approximately 4 x 4 hour sessions over 1 month by a Multicultural Health Coordinator with a maximum of 10 mentors per/session. This format is dependent on health restrictions during the global pandemic. The mentoring intervention will be implemented in public hospitals in Metropolitan areas with cultural diversity. Participating clinics will include services in these hospitals that provide care to people with chronic and complex conditions such and include cardiac and heart failure services, respiratory, diabetes, rheumatology, cancer, renal, pain and allied health clinics. The mentoring intervention within each setting has been designed to be flexible and adaptable to the different clinical settings, diverse cultural backgrounds of Natural Helper mentors and the needs of identified patients. Thus, adaptations will be allowed to the mode of delivery (face to face in the clinic, virtual or phone), frequency of mentoring, duration (time period up to 6-months), dose (number of sessions over 6-months) and content of sessions. For example, pain clinics may integrate the mentor in pain management programs to facilitate coaching with active self management such as activity pacing and exercise, while rheumatology clinics may focus mentoring on adherence to medication and self-monitoring activities. However, core components of the intervention have been defined following the co-design and piloting processes to encompass four core components deemed by the team (consumer, multicultural health, implementation and research team) as critical for a successful peer mentoring partnership. These encompass relationship verification, briefing and debriefing processes, mentoring content and technique and minimum dose parameters as outlined below: I. Relationship verification: Patient and NH mentor acceptance of a match is an important mediator of successful mentoring partnerships. To support relationships and minimise undue conflict between patients and NH mentors, the mentor coordinator will independently debrief each participant and mentor after the initial session and verify both parties’ consent to continue the mentor relationship. Fidelity will be assessed with two questions included in the 6-month patient-participant and mentor-participant survey enquiring about introductions between mentors and mentees and the occurrence of relationship verification. The occurrence of facilitated introduction and relationship verification will be coded from survey responses as 0,1 (0= did not occur; 1 = occurred). II. Briefing and debriefing processes: A critical element of ensuring the mentor-patient relationship complements clinical care is through routine briefing and debriefing between mentors and healthcare providers. Debriefing sessions will be scheduled between mentors and healthcare providers at the end of each session. Fidelity will be assessed via mentor logbooks and the presence of a healthcare provider signature attached to each mentoring session. III. Mentoring content and technique: The content of mentoring discussions will be unscripted and guided by participant needs and the skills/confidence of individual mentors. Mentors will be encouraged to consult their training manuals and resources (developed specifically for this study) and discuss relevant topics during monthly supervision sessions with their coordinator. Core topics will include discussion of emotional well-being, chronic disease management progress, problem-solving/ set-back management and community integration. Mentors will utilise a range of techniques associated with promoting behaviour change and chronic disease self-management2. Key techniques considered core components: active listening, non-judgmental communication, feedback on behaviours (descriptive, non-judgmental and specific), problem solving and action planning, displays of empathy/emotional support. Advice provided by mentors will be grounded in their own experience with chronic disease self-management. Fidelity will be assessed using a purposively designed audit checklist to code the occurrence of key elements as 0,1 (0 did not occur, 1 occurred) and collate for each mentor to achieve a % fidelity for each observed session. Audits will be conducted by a multicultural health officer, experienced in the above techniques, and conducted on a monthly basis. IV. Mode, dose, frequency and duration will be flexible in line with a patient-centred care approach and for supporting adaptability. This will be collaboratively determined between the mentor, HCP and patient. Minimum parameters established include at least three sessions within three months of individual contact, with a strong recommendation for at least one of these sessions conducted face-to-face, pending pandemic and associated clinic restrictions. A minimum duration of 3-months exposure. Beyond this minimum dose, the format and method of mentoring may be extended as desired and encompass varying modes of delivery including individual and group sessions, as determined suitable by the target clinic. The effective duration for peer mentoring cited in the literature is variable ranging from 6-weeks to 6-months, thus the minimum duration encompasses these periods and allows for partnerships to continue for as long as 6-months depending on the clinic and the patient-NH relationships. Fidelity will be assessed via mentor logs, while adaptable elements and actual dose, mode, frequency and duration will be collated and summarised. 2) The Implementation Strategies: The strategies adopted for embedding the NH program in the immediate implementation clusters have been informed by pilot data, the Consolidated Framework for Implementation Research (CFIR) (3) (determinant framework from pilot study), and the adaptation framework (Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) model (4). The strategies will be delivered by the implementation team, led by the Primary Investigator (BB) who is a clinical specialist physiotherapist and postdoctoral clinical research fellow with over 15 years clinical experience working with patients from CALD backgrounds; a multicultural health coordinator and multicultural health officers. The strategies will include: I. Service readiness and needs assessment (plan strategy): A local needs assessment with key service stakeholders conducted pre-implementation to identify readiness and patient needs and resources to support the model. II. Education and training of cultural mentors: 16 hours of training wherein they will be familiarised with concepts of peer mentoring, theory of behaviour change and operational elements of the models. III. Expert shadowing: Three expert-shadowing/joint mentoring sessions will be delivered during the provisional period by an experienced multicultural health officer or experienced past Natural Helper mentor. IV. Audit and Feedback: Observation checklists and feedback on performance will occur weekly for the first month, fortnightly for the second month, then monthly until the end of the active treatment on a randomly selected patient for each NH mentor. V. Ongoing training and NH learning collaborative: Monthly sessions (1 hour) over the study period will be held utilising flexible delivery modes for Natural Helper mentors to engage with other mentors and support staff. VI. Tools for quality monitoring: Debriefing resources will be modified to foster quality Natural Helper-Healthcare provider debriefing VII. Provide ongoing consultation and support: Monthly meetings with clinics to identify potential challenges and support adaptation as necessary. In phase two, delayed implementation clusters will recieve the implementation strategies and intervention. Immediate implementation clusters may continue the program with new patients but no further patient data will be collected from these clusters. Study duration: 20 months (phase 1 and 2 each 10 months) References: 1. Dennis CL. Peer support within a health care context: a concept analysis. Int J Nurs Stud. 2003;40:321-332. 2. Thom DH et al. Impact of peer health coaching on glycemic control in low-income patients with diabetes: a randomized controlled trial. Ann Fam Med. 2013;11:137-144. 3. Damschroder LJ et al. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implementation Science. 2009;4:50. 4. Miller CJ et al. The FRAME-IS: a framework for documenting modifications to implementation strategies in healthcare. Implementation Science. 2021;16:36.

Sponsors

South Western Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Three level of participants will be included. Eligibility is outlined according to each participant group. Patient-participants will be eligible for inclusion if they are i) adults (aged 18 years and above), ii) commencing active treatment with a participating clinic for a chronic condition (>6-months) which the participating clinics determines will require active self-management for at least the next 6-months, iii) self-identify with a CALD community of interest for cultural mentoring by the clinic they are attending, iv) have no cognitive impairment identified by their clinical team that could unduly influence their capacity to give informed consent and v) can give written informed consent. Healthcare Provider-participants will be eligible for inclusion if they are employed by the participating health service, allocated to work in the specific clinic of interest for the 9-month implementation active phase and are anticipated to interact with the Natural Helper mentor during the implementation active phase. The implementation active phase is defined as the time-period for all patient-participants recruited over a 4-month recruitment period to complete their 6-month intervention time-period). Prospective Natural Helper-participants will be eligible for inclusion if they have a lived experience of the condition of interest for a specific clinic, self-identify with the target community identified for mentoring by the clinic based on language, ethnoculture or other cultural identification and have completed the district mandatory requirements for volunteers and consumers and the multicultural health training program.

Exclusion criteria

As a pragmatic trial, there are few exclusion criteria and patient-participants will only be excluded if they speak a language other than those identified by the specific clinic as a target community and/or have a diagnosis that may impair their cognition such as dementia, delirium or severe psychiatric disorder (as assessed by their treating healthcare provider). There are no additional exclusion criteria for Healthcare provider or Natural Helper mentor participants who have met the inclusion criteria.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 3, 2026