Understanding implementation factors and participant experiences of a cluster randomised controlled trial to prevent falls among older Aboriginal people: a process evaluation protocol.

INTRODUCTION

Process evaluations examining programme implementation are often conducted in conjunction with effectiveness studies. Their inclusion in studies with Aboriginal participants can give an understanding of programme delivery in Aboriginal community contexts. The programme was codesigned with Aboriginal communities and includes exercise and facilitated 'yarning' discussion about fall risk and prevention strategies. The programme pilot showed favourable outcomes and acceptability for Aboriginal people aged 45 years and over. The programme is now being compared with a '' programme in a cluster randomised controlled trial within Aboriginal health and community services. An embedded process evaluation aims to explore relationships between participation and programme outcomes and the quality of programme implementation.

METHODS AND ANALYSIS

The process evaluation will use a mixed methods design, guided by Indigenous research methodology. It will evaluate quantitative data (number of completed sessions, site coaching checklist tool, participant and facilitator questionnaire data and a participant habit formation scale), as well as qualitative data (open-ended responses from project and site staff and semistructured interviews using yarning with study participants and site managers). A programme logic model was developed to explain the intended inputs, activities, outputs and outcomes, which guided this process evaluation design.

CONCLUSION

This process evaluation of a fall prevention programme for older Aboriginal people using a mixed methods design and data triangulation will allow for a comprehensive understanding of study findings. Multiple study sites allow for generalisability of findings and exploration of variation across sites.

TRIAL REGISTRATION NUMBER

ACTRN12619000349145.