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Trial registered on ANZCTR


Registration number
ACTRN12622000697785
Ethics application status
Approved
Date submitted
7/04/2022
Date registered
13/05/2022
Date last updated
25/08/2024
Date data sharing statement initially provided
13/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the Natural Helper approach to culturally responsive healthcare for culturally and linguistically diverse (CALD) individuals with chronic health conditions
Scientific title
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.
Secondary ID [1] 306739 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic diseases 325735 0
Condition category
Condition code
Public Health 323078 323078 0 0
Health service research
Musculoskeletal 323338 323338 0 0
Other muscular and skeletal disorders
Respiratory 323339 323339 0 0
Other respiratory disorders / diseases
Cardiovascular 323340 323340 0 0
Other cardiovascular diseases
Cardiovascular 323341 323341 0 0
Diseases of the vasculature and circulation including the lymphatic system
Metabolic and Endocrine 323342 323342 0 0
Diabetes
Renal and Urogenital 323343 323343 0 0
Kidney disease
Cancer 323344 323344 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 323306 0
Behaviour
Intervention code [2] 323307 0
Treatment: Other
Comparator / control treatment
As a pragmatic trial, the control intervention is routine care. Clusters randomised to control will continue usual or routine assessment and treatment processes for all patients until the completion of the cluster RCT phase (phase one) at approximately 10-months. None of the participating clusters currently implement a cultural or peer mentor element, thus it is routine care without the implementation of cultural Natural Helper mentoring. Thereafter control clusters will be eligible to proceed to implementation of the intervention as described for the intervention group. Phase two is also anticipated to be completed over 10 months.
Control group
Active

Outcomes
Primary outcome [1] 330990 0
Patient-Participant Primary Effectiveness Outcome:
Patient-participant change in activation from baseline to 6-months post treatment is the primary effectiveness outcome, evaluated using the Patient Activation Measure (PAM) (1). The PAM is a reliable and valid 13-item self-reported questionnaire that assesses a patient’s knowledge of their health condition and confidence in managing health-related tasks. The PAM has been translated into 22 languages and translated versions will be used as appropriate for patient participants recruited.

1. Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005;40(6 Pt 1):1918-1930.
Timepoint [1] 330990 0
In phase one: Baseline and 6-months post-intervention commencement/routine treatment commencement both groups.

In phase two: Baseline and 6-months post-intervention commencement for the delayed implementation group (previous control group) only.
Secondary outcome [1] 408392 0
Patient-participant secondary effectiveness outcome:
Change in self-efficacy observed between baseline and 6-months post treatment measured using the Self-Efficacy for Managing Chronic Disease 6-item Scale (SEM6S). The SEM6S is a brief questionnaire that evaluates an individual’s confidence in managing fatigue, discomfort, pain, emotional distress or any other symptom associated with managing a chronic condition, validated for use with a broad range of chronic conditions
Timepoint [1] 408392 0
In phase one: Baseline and 6-months post-intervention commencement/routine treatment commencement both groups.

In phase two: Baseline and 6-months post-intervention commencement for the delayed implementation group (previous control group) only.
Secondary outcome [2] 408393 0
Patient-participant secondary effectiveness outcome:
Change in an individual's dispositional and situational coping efforts between baseline and 6-months post treatment will be evaluated using the Brief Coping Orientation to Problems Experienced Inventory (Brief-COPE). This 28-item questionnaire evaluates a respondents utilization of key coping strategies across three sub-scales including problem-focused coping, emotion-focused coping and avoidant coping, to identify the primary coping style adopted to life problems experienced.
Timepoint [2] 408393 0
In phase one: Baseline and 6-months post-intervention commencement/routine treatment commencement both groups.

In phase two: Baseline and 6-months post-intervention commencement for the delayed implementation group (previous control group) only.
Secondary outcome [3] 408394 0
Patient-participant secondary effectiveness outcome:
Health-related quality of life as measured using the EuroQOL-5D (EQ5D-5L). The EQ5D-5L measures five domain sub-scales including mobility, self-care, usual activities, pain or discomfort and anxiety or depression.
Timepoint [3] 408394 0
In phase one: Baseline and 6-months post-intervention commencement/routine treatment commencement both groups.

In phase two: Baseline and 6-months post-intervention commencement for the delayed implementation group (previous control group) only.
Secondary outcome [4] 408395 0
Natural Helper mentor-participant secondary exploratory outcome:
Well-being measured using the Control, Autonomy, Self-Realisation and Pleasure (CASP-19) scale, a reliable and valid measure of overall well-being in older people, across different ethnocultural communities and is independent of other factors influencing well-being such as health. This measure, in conjunction with qualitative methods described, will allow exploration of the influence of mentoring on the mentor’s overall well-being.
Timepoint [4] 408395 0
Phase one: Baseline and completion of mentoring intervention for all natural helper mentors (intervention group only). This will equate to phase one conclusion.
Phase two: Baseline and completion of mentoring intervention for all natural helper mentors (both groups). This will equate to phase two conclusion.
Secondary outcome [5] 408396 0
Healthcare Provider-participant secondary exploratory outcome:
Healthcare provider cultural responsiveness will be measured using the Cultural Competence Assessment Instrument (CCAI), a 30-item self-report measure encompassing two subscales of cultural awareness and sensitivity, and cultural competence behaviours (1).

1. Doorenbos AZ, Schim SM, Benkert R, Borse NN. Psychometric evaluation of the cultural competence assessment instrument among healthcare providers. Nurs Res. 2005;54(5):324-331.
Timepoint [5] 408396 0
Baseline, phase 1 completion (last-participant completed 6-month outcome measure), phase 2 completion for healthcare providers (last participant completed 6-month outcome measures) in both groups.
Secondary outcome [6] 408397 0
Healthcare Provider-participant secondary exploratory outcome:
Healthcare provider patient centeredness will be explored using the Patient-Centred Care Competency Scale (PCCS) (1), a 17-item HCP self-appraisal of their competencies associated with person-centred care activities.

1. Hwang JI. Development and testing of a patient-centred care competency scale for hospital nurses. Int J Nurs Pract. 2015;21(1):43-51.
Timepoint [6] 408397 0
Baseline, phase 1 completion (last-participant completed 6-month outcome measure), phase 2 completion (last-participant completed 6-month outcome measure) for all healthcare providers in both groups.
Secondary outcome [7] 408398 0
Implementation secondary outcomes (Aligned to the RE-AIM Framework)
Patient satisfaction will be one measure of Acceptability of the intervention using the 8-item Client Satisfaction Questionnaire (CSQ-8) (1).

1. Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-237.
Timepoint [7] 408398 0
6-months post-treatment (for patient-participant measure), phase one completion and phase two completion
Secondary outcome [8] 408399 0
Implementation secondary outcomes:
Reach will be assessed as the percentage of patients who meet the eligibility criteria within each cluster that subsequently consent to participate in the trial. This information will be obtained from clinic screening logs.
Timepoint [8] 408399 0
Phase one completion (last-participant in phase one completed 6-month outcome measure) and phase two completion (last participant completed 6-month outcome measure) for both groups.
Secondary outcome [9] 408400 0
Implementation secondary outcomes:
Dose and adapted elements will be assessed via collation of Natural Helper mentor and Co-Ordinator logbooks. These will record the number, frequency and approximate duration of mentoring sessions. The mode and method of mentoring on each occasion (face to face, virtual, phone; group v individual) will be recorded.
Timepoint [9] 408400 0
Phase one and phase two completion defined at the timepoint when the last patient-participant completed their 6-month outcome measure.
Secondary outcome [10] 408401 0
Implementation secondary outcomes:
Fidelity to core components of the intervention will be collected via participant and mentor survey item (for relationship verification), mentor logbooks (signed debriefing records for debriefing core element and mode, dose, frequency and duration records) and audit checklist (from multicultural health auditor checklist for content and technique). These elements will be collated as a composite secondary outcome, designed specifically for this study, that reports on the percentage of core elements fulfilled for each patient-participant.
Timepoint [10] 408401 0
Phase one completion for the intervention group (when the last intervention patient-participant completed their 6-month outcome measure)
Phase two completion for the delayed implementation group (control group from phase one) defined as the time point when the last patient-participant completed their 6-month outcome measure.
Secondary outcome [11] 408402 0
Implementation secondary outcomes:
Cost-effectiveness: Calculation of direct program costings will include coordinator time (measured using electronic schedule of all interviews, training sessions, supervision, and site consultations: number of hours x hourly rate), mentor reimbursement (measured via gift voucher registry as the number of vouchers x amount), other mentor expenses (measured via expense registry - number of expenses x tariff) and program resources and translations (production costs - material quantity x price).

Timepoint [11] 408402 0
Phase one completion for the intervention group (when the last intervention patient-participant completed their 6-month outcome measure)
Phase two completion for the delayed implementation group (control group from phase one) defined as the time point when the last patient-participant completed their 6-month outcome measure.
Secondary outcome [12] 408403 0
Implementation secondary outcomes:

Sustainability will be reported as the number of clusters randomised to the immediate implementation arm who are continuing the model at the project completion (end of phase two), derived from healthcare provider-participant surveys.
Timepoint [12] 408403 0
Phase two completion (point of last patient-participant completing their 6-month outcome measure).
Secondary outcome [13] 408404 0
Secondary implementation outcomes:

Individual interviews will be conducted with a purposive sample of patient-participants to ensure diverse perspectives are captured for the spectrum of conditions of interest included in this study. Interviews will be conducted face-to-face, phone, or virtually, according to participant preference and restrictions imposed on health services at that time and in the participants preferred language, by a bilingual member of the research team experienced in qualitative interviewing or an investigator and NAATI accredited interpreter. A semi-structured interview guide, modelled on the pilot study (under review), mapped to the CFIR determinant framework and designed with consumer input, will be used to explore participants’ experiences with the program, including perceived benefits, challenges and recommendations for improvement.
Timepoint [13] 408404 0
In phase one: Baseline and 6-months post-intervention commencement/routine treatment commencement both groups.

In phase two: Baseline and 6-months post-intervention commencement for the delayed implementation group (previous control group) only.
Secondary outcome [14] 408405 0
Implementation secondary outcomes:
Mentor experiences will be explored through a purposefully designed electronic survey containing both closed multiple response questions and open-ended questions. The survey is based on the qualitative findings from the pilot study, consultation with consumer partners and mapped to the described determined and evaluation frameworks.
Timepoint [14] 408405 0
Phase one completion for Natural Helper mentors from the intervention group (defined as the time when the last-participant in phase one intervention group completed 6-month outcome measure). This is expected to equate to approximately 10 months post first participant enrollment, allowing for a 4-month participant recruitment period.

Phase two completion for Natural Helper mentors from both groups (defined as the time when the last patient-participant completed 6-month outcome measure). This is expected to equate to 20 months post first participant enrollment.
Secondary outcome [15] 408406 0
Implementation secondary outcomes:
Healthcare provider experiences will be explored through a purposefully designed electronic survey containing both closed multiple response questions and open-ended questions. The survey is based on the qualitative findings from the pilot study, consultation with healthcare provider stakeholders and mapped to the previously described determinant and evaluation frameworks.
Timepoint [15] 408406 0
Phase one completion for healthcare-providers from the intervention group (approx 10 months post-enrollment)
Phase two completion for healthcare providers from the delayed implementation group (control group from phase one, approximately 20 months post-enrollment).
Secondary outcome [16] 408735 0
Implementation secondary outcomes (Aligned to the RE-AIM Framework)

Acceptability will also be assessed via auditing of the Multicultural Health Co-Ordinator’s records of NH-patient relationship verification to identify the percentage of participants who did not wish to continue the mentoring relationship after initial matching.
Timepoint [16] 408735 0
Phase one completion for the intervention group (approximately 10-months post project commencement/first patient-participant enrollment).
Phase two completion for the delayed implementation group (control group, approximately 20 months post project commencement/first patient-participant enrollment).
Secondary outcome [17] 408736 0
Implementation secondary outcomes (Aligned to the RE-AIM Framework)
Acceptability from the perspective of patient and healthcare provider’s will be explored using semi-structured individual interviews and/or focus groups conducted in participants preferred language. Participant preference will determine format (individual interview or focus group) and a topic guide will initially guide discussions, although this will evolve throughout successive interviews as analyses progress.
Timepoint [17] 408736 0
Phase one: 6-months post treatment commencement for patient-participant interviews and phase one completion (approximately 10-months post first patient-participant enrollment) for healthcare provider interviews.

Phase two: 6-months post treatment commencement for phase two patient-participants and phase two completion (approximately 20 months post first patient-participant enrollment) for healthcare provider interviews.
Secondary outcome [18] 408739 0
Reach will also be assessed via service level data derived from the electronic medical record. Specifically, attendance over the 6-month treatment period (number of sessions scheduled, number of sessions attended, number of cancellations/failures to attend).
Timepoint [18] 408739 0
In phase one: Baseline and 6-months post-intervention commencement/routine treatment commencement both groups.

In phase two: Baseline and 6-months post-intervention commencement for the delayed implementation group (previous control group) only.
Secondary outcome [19] 408740 0
Secondary implementation outcomes:
Fidelity to the implementation strategies will be descriptively summarized from Healthcare provider and mentor surveys. The survey's have been designed from pilot data and consumer/past-mentor input to be specific to this study.
Timepoint [19] 408740 0
Phase one completion for the intervention group (approximately 10-months from first patient-participant enrollment)
Phase two completion for the delayed implementation group (control group, approximately 20 months from first patient-participant enrollment).
Secondary outcome [20] 408741 0
Implementation secondary outcomes
Sustainability from a healthcare provider perspective will also be assessed via the Clinical Sustainability Assessment Tool (CSAT) (1). The CSAT is a 35-item self-reported questionnaire that assesses organizational capacity for the sustainability of an initiative in a clinical setting.

(1) Malone, S., K. Prewitt, R. Hackett, J. C. Lin, V. McKay, C. Walsh-Bailey and D. A. Luke (2021). "The Clinical Sustainability Assessment Tool: measuring organizational capacity to promote sustainability in healthcare." Implementation Science Communications 2(1): 77.
Timepoint [20] 408741 0
Phase one completion for the intervention groups (approximately 10-months from first patient-participant enrollment)
Phase two completion for the delayed implementation groups (control group, approximately 20 months from first patient-participant enrollment).
Secondary outcome [21] 408742 0
Implementation secondary outcome
Sustainability from a Natural Helper Mentor perspective will also be informed by mixed-methods synthesis (composite outcome) of responses in the NH-participant survey (specifically developed for this study) and findings from Natural Helper semi-structured individual interviews or focus groups
Timepoint [21] 408742 0
Phase one completion for the intervention NH-mentor participants (approximately 10-months from first patient-participant enrollment)
Phase two completion for all NH mentor participants (approximately 20 months from first patient-participant enrollment).
Secondary outcome [22] 408743 0
Mentor experiences will also be explored via semi-structured individual interviews or focus groups (according to participant preference and availability). The participants will be sampled based on Natural Helper mentor survey results to provide an in-depth understanding of the characteristics of successful and potentially unsuccessful mentoring relationships. Interviews or focus group sessions will be guided by a semi-structured interview guide adapted from the pilot study and be audio-recorded and transcribed for analysis.
Timepoint [22] 408743 0
Phase one completion for the intervention NH-mentor participants (approximately 10-months from first patient-participant enrollment)
Phase two completion for all NH mentor participants (approximately 20 months from first patient-participant enrollment). .
Secondary outcome [23] 408744 0
Implementation secondary outcomes
Healthcare provider experiences will also be explored via a qualitative semi-structured focus group (or interview if participant is unavailable) with a maximum of 6 participants to provide an in-depth understanding of the characteristics of successful and less successful mentoring programs. A semi-structured interview guide will guide initial discussions, although this may evolve as analysis proceeds. Interviews/focus groups will be audio-recorded and transcribed for analysis
Timepoint [23] 408744 0
Phase one completion for intervention group healthcare provider participants (approximately 10-months from first patient-participant enrollment)
Phase two completion for delayed implementation healthcare provider participants (control group, approximately 20 months from first patient-participant enrollment).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will occur at a cluster level. At the time of randomisation, the chief investigator will contact the study bio statistician, who has prepared the randomisation schedule and who is off-site and independent of the implementation team and outcome assessors. All study participants in a cluster will be assigned to the same study arm thus individual participant allocation will not occur.


Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sixteen clinics will be randomised to the intervention (immediate implementation) or control (delayed implementation) using block randomisation, with a block size of two. Matching clusters according to similarities in conditions of interest and/or disease trajectory and using a block size of two will ensure relative balance in the outcome expectancies for the diverse chronic disease clusters.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Two phase design:
Phase one is a type 1 hybrid effectiveness-implementation cluster randomised controlled trial. Phase two is an extension of the trial, using a before-and-after design and mixed-methods to allow control clusters to implement the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: Using parameter estimates derived from a multilevel model of pilot data, we conducted a simulation study to estimate sample size. A minimum sample of 240 patients (15 patients over at least 16 clusters with equal allocation of clusters into intervention and control groups) was calculated to be sufficient to find an improvement of 6.5 points in the PAM between clusters that were part of the intervention group compared with those in a control group, achieving 81% power, 5% statistical significance and allowing for a loss to follow up of 20%. These calculations have been based on pilot data demonstrating a 10-point higher PAM for participants exposed to a mentor and exceeds the minimal detectable difference of four points14. In the simulation, we assumed conservative variance parameters estimated from the pilot data by variance + 1.96*SE(variance), which gave random intercept variance (clinic) =121, residual variance = 239, co-variance of the pre-and post-measurements = 111. Fixed effect parameters were intercept = 64.7, phase coefficient = 7.1, time coefficient = 10.2, time x phase interaction coefficient = 6.5.

For phase two, a sample of 120 participants (8 control clusters x 15 participants per cluster) will be sufficient to explore trends of effectiveness, comparing patient activation measure scores in these clusters with those from the same clusters in phase one, powered for a large effect size only.

Analysis Plan:
Phase One Analyses: The study biostatistician, blinded to cluster allocation will use a 2-multilevel model to model PAM, with a random intercept of clinic, fixed effects of allocation, time and an allocation by time interaction as the main variables of interest in the model. The coefficient of the allocation by time interaction will provide the difference in the changes of PAM from pre to post between the allocation groups. Analysis will be adjusted to control for covariates that may be related to level of activation (e.g. education, age, English proficiency and gender).

Secondary analyses: Similar 2-level multilevel models, adjusted for potential confounders, will model secondary continuous outcomes. The coefficient of the allocation by time interaction will provide the difference in the changes of the secondary outcomes from pre to post between the allocation groups.

Phase Two Analyses: A 2-level multilevel model will be used to model PAM, with a random intercept effect of clinic (cluster), before and after-phase as the primary independent variable, time, and an interaction between phase and time. The coefficient of the phase by time interaction will provide the difference in the changes of the PAM from pre to post between the phases. All other patient related outcomes (PAM, SEM6S, Brief COPE and EQ5D) will be analysed in similar manner.

Implementation and mixed methods analysis: Implementation outcome analysis of measures of acceptability (patient satisfaction: CSQ-8) and reach will be evaluated using between-group comparisons using linear models. A within-study Cost Utility Analysis of the Natural Helper intervention will be conducted at 6-months compared to the usual care intervention The remaining implementation measures (acceptability, dose, fidelity and sustainability measures) and determinants will be descriptively presented. Audio-recordings of interviews and focus groups will be transcribed verbatim and imported into NVivo (Version 12 produced by QSR International, Melbourne, VIC, Australia). A rapid assessment process including data categorisation and coding by two members of the research team experienced in qualitative analysis mapped to the RE-AIM and CFIR frameworks. This data will be used to expand upon the results from the pragmatic trial to understand the implementation processes as experienced by the healthcare provider and natural helper stakeholders.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
10/08/2023
Date of last participant enrolment
Anticipated
1/01/2025
Actual
Date of last data collection
Anticipated
30/01/2025
Actual
Sample size
Target
360
Accrual to date
242
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22138 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 22139 0
Fairfield Hospital - Prairiewood
Recruitment hospital [3] 22140 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [4] 22141 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [5] 25749 0
Sunshine Hospital - St Albans
Recruitment hospital [6] 25750 0
Williamstown Hospital - Williamstown
Recruitment postcode(s) [1] 37262 0
2170 - Liverpool
Recruitment postcode(s) [2] 37263 0
2176 - Prairiewood
Recruitment postcode(s) [3] 37264 0
2200 - Bankstown
Recruitment postcode(s) [4] 37265 0
2560 - Campbelltown
Recruitment postcode(s) [5] 41573 0
3021 - St Albans
Recruitment postcode(s) [6] 41574 0
3016 - Williamstown

Funding & Sponsors
Funding source category [1] 310984 0
Government body
Name [1] 310984 0
South Western Sydney Local Health District
Country [1] 310984 0
Australia
Funding source category [2] 315069 0
Government body
Name [2] 315069 0
Medical Research Future Fund (MRFF) Consumer led Research Scheme
Country [2] 315069 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
SWSLHD Multicultural Services
5/39 Stanley Street Bankstown, NSW 2200
Country
Australia
Secondary sponsor category [1] 312295 0
None
Name [1] 312295 0
Address [1] 312295 0
Country [1] 312295 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310539 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 310539 0
South Western Sydney Local Health District (SWSLHD) HREC
Locked Bag 7279 Eastern Campus Liverpool BC NSW 1871
Ethics committee country [1] 310539 0
Australia
Date submitted for ethics approval [1] 310539 0
25/11/2021
Approval date [1] 310539 0
20/01/2022
Ethics approval number [1] 310539 0
2021/ETH12279

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118010 0
Dr Bernadette Brady
Address 118010 0
Department of Pain Medicine,
Liverpool Hospital
Locked Bag 7103, Liverpool BC NSW 1871
Country 118010 0
Australia
Phone 118010 0
+61 28738 3885
Fax 118010 0
Email 118010 0
[email protected]
Contact person for public queries
Name 118011 0
Bernadette Brady
Address 118011 0
Department of Pain Medicine,
Liverpool Hospital
Locked Bag 7103, Liverpool BC NSW 1871
Country 118011 0
Australia
Phone 118011 0
+61 28738 7200
Fax 118011 0
Email 118011 0
[email protected]
Contact person for scientific queries
Name 118012 0
Bernadette Brady
Address 118012 0
Department of Pain Medicine,
Liverpool Hospital
Locked Bag 7103, Liverpool BC NSW 1871
Country 118012 0
Australia
Phone 118012 0
+61 28738 7200
Fax 118012 0
Email 118012 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
De-identified raw, line-by-line data for each participant will not be available for data sharing due to ethical approval restrictions. Rather, aggregated data supporting the findings of the effectiveness components of the study are available from the primary author, upon reasonable request.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15689Study protocol    The trial protocol will be linked and available as... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Natural Helper approach to culturally responsive disease management: Protocol for a type 1 effectiveness-implementation cluster randomised controlled trial of a cultural mentor programme.2023https://dx.doi.org/10.1136/bmjopen-2022-069120
N.B. These documents automatically identified may not have been verified by the study sponsor.