The Natural Helper approach to culturally responsive disease management: protocol for a type 1 effectiveness-implementation cluster randomised controlled trial of a cultural mentor programme

INTRODUCTION: Chronic disease is a leading cause of death and disability that disproportionately burdens culturally and linguistically diverse (CALD) communities. Self-management is a cornerstone of effective chronic disease management. However, research suggests that patients from CALD communities may be less likely to engage with self-management approaches. The Natural Helper Programme aims to facilitate patient engagement with self-management approaches (ie, ‘activation’) by embedding cultural mentors with lived experience of chronic disease into chronic disease clinics/programmes. The Natural Helper Trial will explore the effect of cultural mentors on patient activation, health self-efficacy, coping efforts and health-related quality of life (HRQoL) while also evaluating the implementation strategy. METHODS AND ANALYSIS: A hybrid type-1 effectiveness-implementation cluster-randomised controlled trial (phase one) and a mixed-method controlled before-and-after cohort extension of the trial (phase 2). Hospital clinics in highly multicultural regions in Australia that provide healthcare for patients with chronic and/or complex conditions, will participate. A minimum of 16 chronic disease clinics (clusters) will be randomised to immediate (active arm) or delayed implementation (control arm). In phase 1, the active arm will receive a multifaceted strategy supporting them to embed cultural mentors in their services while the control arm continues with usual care. Each cluster will recruit an average of 15 patients, assessed at baseline and 6 months (n=240). In phase 2, clusters in the control arm will receive the implementation strategy and evaluate the intervention on an additional 15 patients per cluster, while sustainability in active arm clusters will be assessed qualitatively. Change in activation over 6 months, measured using the Patient Activation Measure will be the primary effectiveness outcome, while secondary effectiveness outcomes will explore changes in chronic disease self-efficacy, coping strategies and HRQoL. Secondary implementation outcomes will be collected from patient–participants, mentors and healthcare providers using validated questionnaires, customised surveys and interviews aligning with the Reach, Effectiveness, Adoption, Implementation, Maintenance framework to evaluate acceptability, reach, dose delivered, sustainability, cost-utility and healthcare provider determinants. ETHICS AND DISSEMINATION: This trial has full ethical approval (2021/ETH12279). The results from this hybrid trial will be presented at scientific meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12622000697785.