Background Inhospital falls cause morbidity, staff burden and increased healthcare costs. It is unclear if the persistent problem of inhospital falls is due to the use of ineffective interventions or their suboptimal implementation. The 6-PACK programme appears to reduce fall injuries and a randomised controlled trial (RCT) was undertaken to confirm effects. This paper describes the protocol for the preimplementation studies that aimed to identify moderators of the effective use of the 6-PACK programme to inform the development of an implementation plan to be applied in the RCT.
Methods The 6-PACK project included five preimplementation studies: (1) a profile of safety climate; (2) review of current falls prevention practice; (3) epidemiology of inhospital falls; (4) acceptability of the 6-PACK programme; and (5) barriers and enablers to implementation of the 6-PACK programme. The Theoretical Domain Framework that includes 12 behaviour change domains informed the design of these studies that involved 540 staff and 8877 patients from 24 wards from six Australian hospitals. Qualitative and quantitative methods were applied with data collected via: structured bedside observation; daily nurse unit manager verbal report of falls; audit of medical records, incident reporting and hospital administrative data; surveys of ward nurses; focus groups with ward nurses; and key informant interviews with senior staff.
Discussion Information on contextual, system, intervention, patient and provider level factors is critical to the development of an implementation plan. Information gained from these studies was used to develop a plan applied in the RCT that addressed the barriers and harnessed enablers.
Trial registration number The RCT is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000332921.
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Contributors ALB led the conception, design and application for funding of the project in conjunction with CAB and KDH. ALB, RTM, CAB, KDH and FSL participated in the steering committee and project governance. ALB and DRA led the drafting of all sections of this manuscript. All authors reviewed and revised the manuscript critically for important intellectual content and provided approval of the final version to be published. ALB is the guarantor of the manuscript.
Funding This project was funded by the National Health and Medical Research Council (NHMRC), Australia (APP1007627). ALB's salary was funded by a Career Development Fellowship from the NHMRC (APP1067236). RTM's salary was supported by a postgraduate scholarship from the NHMRC (APP1055604).
Competing interests None declared.
Ethics approval Monash University Human Research Ethics Committee—CF11/0229—2011000072 and each of the relevant hospital ethics committees.
Provenance and peer review Not commissioned; internally peer reviewed.