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The 6-PACK programme to decrease fall-related injuries in acute hospitals: protocol for a cluster randomised controlled trial
  1. Anna Barker1,
  2. Caroline Brand1,
  3. Terry Haines2,
  4. Keith Hill3,
  5. Sandy Brauer4,
  6. Damien Jolley1,
  7. Mari Botti5,
  8. Robert Cumming6,
  9. Patricia M Livingston5,
  10. Cathie Sherrington7,
  11. Silva Zavarsek8,
  12. Renata Morello1,
  13. Jeannette Kamar9
  1. 1The Centre for Research Excellence in Patient Safety, Department of Epidemiology and Preventative Medicine, Monash University, Victoria, Australia
  2. 2Physiotherapy Department, Monash University and Allied Health Research Unit, Southern Health, Monash University, Victoria, Australia
  3. 3Faculty of Health Sciences, La Trobe University and Northern Health, Victoria Australia
  4. 4Division of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia
  5. 5Epworth/Deakin Centre for Clinical Nursing Research, Deakin University, Victoria, Australia
  6. 6School of Public Health and ANZAC Research Institute, Sydney Medical School, The University of Sydney, New South Wales, Australia
  7. 7The George Institute for Global Health, The University of Sydney, New South Wales, Australia
  8. 8Centre for Health Economics, Monash University, Victoria, Australia
  9. 9Northern Health, Melbourne, Victoria, Australia
  1. Correspondence to Dr Anna Luica Barker, Centre of Research Excellence in Patient Safety, Monash University, Melbourne, Victoria, Australia; anna.barker{at}


Background and aims In-hospital fall-related injuries are a source of personal harm, preventable hospitalisation costs, and access block through increased length of stay. Despite increased fall prevention awareness and activity over the last decade, rates of reported fall-related fractures in hospitals appear not to have decreased. This cluster randomised controlled trial (RCT) aims to determine the efficacy of the 6-PACK programme for preventing fall-related injuries, and its generalisability to other acute hospitals.

Methods 24 acute medical and surgical wards from six to eight hospitals throughout Australia will be recruited for the study. Wards will be matched by type and fall-related injury rates, then randomly allocated to the 6-PACK intervention (12 wards) or usual care control group (12 wards). The 6-PACK programme includes a nine-item fall risk assessment and six nursing interventions: ‘falls alert’ sign; supervision of patients in the bathroom; ensuring patient's walking aids are within reach; establishment of a toileting regime; use of a low-low bed; and use of bed/chair alarm. Intervention wards will be supported by a structured implementation strategy. The primary outcomes are fall and fall-related injury rates 12 months following 6-PACK implementation.

Discussion This study will involve approximately 16 000 patients, and as such is planned to be the largest hospital fall prevention RCT to be undertaken and the first to be powered for the important outcome of fall-related injuries. If effective, there is potential to implement the programme widely as part of daily patient care in acute hospital wards where fall-related injuries are a problem.

Trial registration The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611000332921).

  • Fall
  • clinical care
  • mixed methods
  • hospital care
  • public health
  • concussion
  • behavior change
  • public health
  • pedestrian
  • implementation/translation
  • randomized trial
  • older people

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  • Funding National Health & Medical Research Council, Australia (APP1007627).

  • Competing interests None.

  • Ethical approval Multi-centre approval has been granted by Monash University Human Research Ethics Committee (project number: CF11/0229: 2011000072). Site-specific approval will be obtained from local ethics committees at all participating hospitals.

  • Provenance and peer review Not commissioned; externally peer reviewed