Elsevier

Social Science & Medicine

Volume 69, Issue 12, December 2009, Pages 1767-1776
Social Science & Medicine

Studying large-scale programmes to improve patient safety in whole care systems: Challenges for research

https://doi.org/10.1016/j.socscimed.2009.09.051Get rights and content

Abstract

Large-scale national and multi-institutional patient safety improvement programmes are being developed in the health care systems of several countries to address problems in the reliability of care delivered to patients. Drawing upon popular collaborative improvement models, these campaigns are ambitious in their aims to improve patient safety in macro-level systems such as whole health care organisations. This article considers the methodological issues involved in conducting research and evaluation of these programmes. Several specific research challenges are outlined, which result from the complexity of longitudinal, multi-level intervention programmes and the variable, highly sociotechnical care systems, with which they interact. Organisational-level improvement programmes are often underspecified due to local variations in context and organisational readiness for improvement work. The result is variable implementation patterns and local adaptations. Programme effects span levels and other boundaries within a system, vary dynamically or are cumulative over time and are problematic to understand in terms of cause and effect, where concurrent external influences exist and the impact upon study endpoints may be mediated by a range of organisational and social factors.

We outline the methodological approach to research in the United Kingdom Safer Patients Initiative, to exemplify how some of the challenges for research in this area can be met through a multi-method, longitudinal research design. Specifically, effective research designs must be sensitive to complex variation, through employing multiple qualitative and quantitative measures, collect data over time to understand change and utilise descriptive techniques to capture specific interactions between programme and context for implementation. When considering the long-term, sustained impact of an improvement programme, researchers must consider how to define and measure the capability for continuous safe and reliable care as a property of the whole care system. This requires a sociotechnical approach, rather than focusing upon one microsystem, disciplinary perspective or single level of the system.

Introduction

In the UK and other countries, large-scale national and multi-institutional patient safety improvement programmes are beginning to emerge, to address the problems of patient safety and reliability in care that have been highlighted by a series of influential reports (eg. Dept. Health, 2000, Kohn et al., 2000). Such safety improvement programmes and campaigns are ambitious in their aims and represent intervention on a scale not seen before in health care. Current national campaigns are being designed on the basis that it is only through organisational-level development that any gains made in patient safety will be sustained and may be replicated throughout the system.

As our understanding of the origins and causes of failures grows, practical knowledge concerning how to rectify the problems and improve systems lags somewhere behind. Until recently, the majority of improvement initiatives may be considered to have been focused at the microsystems level within a health care organisation. There is now growing recognition, that patient safety and the capacity of an organisation to deliver consistent, high-quality and failure-free care is both a systemic issue and one that needs to be addressed at the level of the whole organisation or care system. If we are to understand how large-scale programmes can become effective in meeting these aims, we need research designs that are sensitive to the complexity involved in intervening to change whole systems. In this article, we discuss the challenges for research into large-scale patient safety improvement programmes, drawing upon our experience of developing research into the Safer Patients Initiative, a large-scale improvement programme in the United Kingdom.

Section snippets

Research into organisational-level improvement programmes

Several authors have drawn attention to the limited evidence base for the efficacy of large-scale improvement programmes in health care (eg. Mittman, 2004, Shojania and Grimshaw, 2005). The majority of the available research relates to the popular breakthrough collaborative programme model (Institute for Healthcare Improvement, 2004), which involves teams from multiple institutions working together to focus upon improvement in a specific clinical area (eg. Bate et al., 2002, Kilo, 1998). Rather

The challenges for research design

Large-scale improvement programmes provide a number of challenges for research design, due to the inherent complexity in attempting to achieve effects in large-scale adaptive sociotechnical systems, such as a hospital site or whole health care organisation. In the discussion that follows, we first consider the research challenges that must be overcome to improve our understanding of these programmes, before describing a specific example of applied research in this area, to exemplify the

A practical example: research design for the UK Safer Patients Initiative

In order to illustrate how the research challenges outlined above influence applied research in this area, we turn to a practical example from the authors' current research based upon a large-scale safety improvement programme in the United Kingdom: The Safer Patient's Initiative (2004–2008). This work sought to understand the ‘journey to safety’ in 24 hospital sites, or how whole health care organisations can make significant and sustainable improvements in the quality and safety of care

Research limitations

We have described how one possible research design may meet the challenges of complexity in a large-scale intervention, but as with all methodological decisions under resource constraints, the reality is that in selecting one approach over another, the researcher makes various trade-offs. The relative virtues of qualitative and quantitative approaches and their combination in mixed-methods designs have been discussed elsewhere (Bryman and Teevan, 2001, Pope and Mays, 1995, Pope and Mays, 2000).

Implications and conclusions

We have discussed a number of methodological issues pertinent to the design of research into large-scale improvement programmes and have considered these in the context of a practical example in the UK. The characteristics, inherent complexity and multi-level nature of these programmes as systems for change pose some unique challenges for researchers. This is particularly the case where programme effects span levels within a system; vary dynamically or are cumulative over time; where

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