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Understanding implementation factors and participant experiences of a cluster randomised controlled trial to prevent falls among older Aboriginal people: a process evaluation protocol
  1. Rona Macniven1,2,
  2. Julieann Coombes3,
  3. Roland Wilson4,
  4. Aaron Simon1,3,
  5. Tamara Mackean3,4,
  6. Kate Hunter3,
  7. Tracey Ma1,3,
  8. Josephine Gwynn2,5,
  9. Catherine Sherrington6,
  10. Anne Tiedemann6,
  11. Anne-Marie Hill7,
  12. Kim Delbaere1,8,
  13. Carolyn Lewis7,
  14. Keziah Bennett-Brook3,
  15. Adam Howie1,
  16. Georgia Stewart9,
  17. Madison Shakespeare4,
  18. Kris Rogers3,10,
  19. Rebecca Q Ivers1,3,
  20. Kathleen Clapham9
  1. 1School of Population Health, The University of New South Wales, Sydney, New South Wales, Australia
  2. 2Poche Centre for Indigenous Health, The University of Sydney, Sydney, New South Wales, Australia
  3. 3The George Institute for Global Health, The University of New South Wales, Sydney, New South Wales, Australia
  4. 4Southgate Institute for Health, Society, and Equity, Flinders University, Adelaide, South Australia, Australia
  5. 5Faculty of Health Sciences, The University of Sydney, Sydney, New South Wales, Australia
  6. 6Institute for Musculoskeletal Health, School of Public Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia
  7. 7School of Physiotherapy and Exercise Science, Curtin University, Bentley, Perth, Australia
  8. 8Neuroscience Research Australia, University of New South Wales, Sydney, New South Wales, Australia
  9. 9Ngarruwan Ngadju First Peoples Health and Wellbeing Research Centre, Australian Health Services Research Institute, University of Wollongong, Wollongong, New South Wales, Australia
  10. 10Graduate School of Health, University of Technology Sydney, Ultimo, New South Wales, Australia
  1. Correspondence to Dr Rona Macniven, School of Population Health, The University of New South Wales, Sydney, NSW 2052, Australia; r.macniven{at}


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 Ironbark: Standing Strong and Tall 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 Ironbark: Standing Strong and Tall programme is now being compared with a ‘Healthy Community’ 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.

  • fall
  • programme evaluationx
  • older people
  • indigenous
  • health services
  • process/impact evaluation

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  • Twitter @rebeccaivers, @kathleenclapham

  • Contributors RM led the writing of this paper. Study investigators (CS, AT, A-MH, KC, TaM, KH, JG, KD, KR and RQI) had overall responsibility for the conception of this study with scientific input. The process evaluation working group and project officers (JC, RW, AS, TrM, CL, KB-B, AH, GS and MS) contributed expertise to the development of the process evaluation tools and programme logic model. All authors contributed to the writing of this paper and approved the final draft.

  • Funding This work was supported by the Australian National Health and Medical Research Council grant number (NMHRC Project grant No. 1143085).

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval Ethical approval has been obtained from the Aboriginal Health & Medical Research Council Ethics Committee (NSW) (140118), the Aboriginal Health Research Ethics Committee of South Australia (418790), the Western Australian Aboriginal Health Ethics Committee (962), the Southern Adelaide Clinical Human Research Ethics Committee (HREC/19/SAC/65) and Curtin University (HRE2020-0069) through the National Mutual Acceptance of ethical and scientific review for multicentre human research projects conducted in public health organisations. These ethics approvals have been noted by the University of New South Wales.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement There are no additional data in this protocol.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.