Effects of auditing patient safety in hospital care: design of a mixed-method evaluation

Abstract

BackgroundAuditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance. Audits are broadly conducted in hospitals, but little is known about their effects on the behaviour of healthcare professionals and patient safety outcomes. This study was initiated to evaluate the effects of patient safety auditing in hospital care and to explore the processes and mechanisms underlying these effects.Methods and designOur study aims to evaluate an audit system to monitor and improve patient safety in a hospital setting. We are using a mixed-method evaluation with a before-and-after study design in eight departments of one university hospital in the period October 2011–July 2014. We measure several outcomes 3 months before the audit and 15 months after the audit. The primary outcomes are adverse events and complications. The secondary outcomes are experiences of patients, the standardised mortality ratio, prolonged hospital stay, patient safety culture, and team climate. We use medical record reviews, questionnaires, hospital administrative data, and observations to assess the outcomes. A process evaluation will be used to find out which components of internal auditing determine the effects.DiscussionWe report a study protocol of an effect and process evaluation to determine whether auditing improves patient safety in hospital care. Because auditing is a complex intervention targeted on several levels, we are using a combination of methods to collect qualitative and quantitative data about patient safety at the patient, professional, and department levels. This study is relevant for hospitals that want to early detect unsafe care and improve patient safety continuously.Trial registrationNetherlands Trial Register (NTR): NTR3343

Optimal governance of patient safety: A qualitative study on barriers to and facilitators for effective internal audit

“…[11] However, knowledge about the critical factors for effective auditing for governance of patient safety is limited. [14,15] Better insight into the barriers and facilitators for effective auditing could contribute to the effective implementation of audit systems and optimising existing audit systems in hospitals.…”

“…[12,13] Users of the information deriving from the internal audit are therefore up to date regarding the actions that must be undertaken to improve patient safety. [11,12] The aim of the internal audit system in Dutch hospitals is described in Table 1.…”

“…[9,10] In almost every Dutch hospital, boards use information deriving from internal audits. [11] The Dutch internal audit system is an "objective assurance and consulting system for detecting patients' risks of adverse events early, and it should encourage the continuous improvement of patient safety". [11] It is a method that is implemented to measure whether organisational preconditions for safe care are in place and to induce improvements when they are not.…”

“…[11] It is a method that is implemented to measure whether organisational preconditions for safe care are in place and to induce improvements when they are not. [11] The internal audit is initiated by hospital boards and implemented top-down. Using a combination of different methods, for example interviews, observations and chart reviews, an internal audit is able to reveal underlying factors causing safety risks and poor safety outcomes, such as high mortality rates.…”

Evaluation of the organisation and effectiveness of internal audits to govern patient safety in hospitals: a mixed-methods study

“…The internal audit is an ‘objective assurance and consulting system for detecting patients’ risks of adverse events early’, which ‘should encourage the continuous improvement of patient safety’. 16 It is a systematic evaluation of the quality system of a hospital which aims to improve patient safety by measuring performance of healthcare providers and preconditions for safe care and comparing these outcomes with (national) standards and guidelines. The measurements are performed by an audit team existing of internal peers (ie, employees of a hospital who audit colleagues of other departments).…”