Improving health system responses when patients are harmed : A protocol for a multistage mixed-methods study

Introduction: At least 10% of hospital admissions in high-income countries, including Australia, are associated with patient safety incidents, which contribute to patient harm (‘adverse events’). When a patient is seriously harmed, an investigation or review is undertaken to reduce the risk of further incidents occurring. Despite 20 years of investigations into adverse events in healthcare, few evaluations provide evidence of their quality and effectiveness in reducing preventable harm.

This study aims to develop consistent, informed and robust best practice guidance, at state and national levels, that will improve the response, learning and health system improvements arising from adverse events.

Methods and analysis: The setting will be healthcare organisations in Australian public health systems in the states of New South Wales, Queensland, Victoria and the Australian Capital Territory. We will apply a multistage mixed-methods research design with evaluation and in-situ feasibility testing. This will include literature reviews (stage 1), an assessment of the quality of 300 adverse event investigation reports from participating hospitals (stage 2), and a policy/procedure document review from participating hospitals (stage 3) as well as focus groups and interviews on perspectives and experiences of investigations with healthcare staff and consumers (stage 4). After triangulating results from stages 1–4, we will then codesign tools and guidance for the conduct of investigations with staff and consumers (stage 5) and conduct feasibility testing on the guidance (stage 6). Participants will include healthcare safety systems policymakers and staff (n=120–255) who commission, undertake or review investigations and consumers (n=20–32) who have been impacted by adverse events.

Ethics and dissemination: Ethics approval has been granted by the Northern Sydney Local Health District Human Research Ethics Committee (2023/ETH02007 and 2023/ETH02341).

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.

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This work was supported by the National Health and Medical Research Council Partnership Grant (Grant Number 2017219). The grant has been funded by the Clinical Excellence Commission (NSW), Clinical Excellence Queensland, Safer Care Victoria, and ACT Health. The Australian Commission on Safety and Quality in Health Care is a non-financial partner. The grant will be led by Macquarie University and supported by Chief Investigators from the University of New South Wales, the University of the Sunshine Coast and the Australian Catholic University.