Anam Parand

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

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.

The role of hospital managers in quality and patient safety: a systematic review

Objectives To review the empirical literature to identify the activities, time spent and engagement of hospital managers in quality of care. Design A systematic review of the literature. Methods A search was carried out on the databases MEDLINE, PSYCHINFO, EMBASE, HMIC. The search strategy covered three facets: management, quality of care and the hospital setting comprising medical subject headings and key terms. Reviewers screened 15 447 titles/abstracts and 423 full texts were checked against inclusion criteria. Data extraction and quality assessment were performed on 19 included articles. Results The majority of studies were set in the USA and investigated Board/senior level management. The most common research designs were interviews and surveys on the perceptions of managerial quality and safety practices. Managerial activities comprised strategy, culture and data-centred activities, such as driving improvement culture and promotion of quality, strategy/goal setting and providing feedback. Significant positive associations with quality included compensation attached to quality, using quality improvement measures and having a Board quality committee. However, there is an inconsistency and inadequate employment of these conditions and actions across the sample hospitals. Conclusions There is some evidence that managers’ time spent and work can influence quality and safety clinical outcomes, processes and performance. However, there is a dearth of empirical studies, further weakened by a lack of objective outcome measures and little examination of actual actions undertaken. We present a model to summarise the conditions and activities that affect quality performance.

Perceptions of the impact of a large‐scale collaborative improvement programme: experience in the UK Safer Patients Initiative

RATIONALE AND AIMS In several countries, collaborative improvement programmes involving multiple health care organizations have been developed to address the issue of patient safety and reliability of care at an organization-wide level. In the UK, the Health Foundations Safer Patients Initiative (SPI) was developed to achieve breakthrough improvement in the quality and safety of care in 24 acute hospital Trusts between 2004 and 2008. Research evidence for the effectiveness of programmes of this type and the mechanisms by which positive outcomes are achieved remains limited. We report a multi-method preliminary study based upon phase 1 of SPI to understand participants perceptions of the local impact of the programme and to form the basis of future research in this area. METHODS Data were collected on the perceived local impact of SPI on a range of clinical, organizational and social dimensions relating to care quality and safety. Data were collected retrospectively from local SPI programme improvement teams using semi-structured interviews and surveys. Qualitative and quantitative analyses were performed, and the results synthesized under common themes and frameworks. RESULTS Specific dimensions of care systems commonly considered to be affected by SPI, included culture, strategic priority, organizational capability and clinical care delivery. Survey data revealed the perceived importance for success of a range of programme components: quality improvement methodology, learning sessions and programme faculty support, along with predefined clinical practice changes. Safety climate and capability dimensions rated as most sensitive to the effects of the SPI programme related to multi-professional engagement and communication, the degree of routine monitoring of care processes and the capacity to evaluate the impact of changes to clinical work systems. CONCLUSIONS Study findings support the view that programmes such as SPI have considerable impact upon the cultural, inter-professional, strategic and organizational aspects of care delivery, in addition to clinical working practices. The specific implications for understanding the effects of complex organization-level interventions and future research design are discussed.

Aviation and healthcare: a comparative review with implications for patient safety

Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing.

Factors predicting change in hospital safety climate and capability in a multi-site patient safety collaborative: a longitudinal survey study

Objective The study had two specific objectives: (1) To analyse change in a survey measure of organisational patient safety climate and capability (SCC) resulting from participation in the UK Safer Patients Initiative and (2) To investigate the role of a range of programme and contextual factors in predicting change in SCC scores. Design Single group longitudinal design with repeated measurement at 12-month follow-up. Setting Multiple service areas within NHS hospital sites across England, Wales, Scotland and Northern Ireland. Participants Stratified sample of 284 respondents representing programme teams at 19 hospital sites. Intervention A complex intervention comprising a multi-component quality improvement collaborative focused upon patient safety and designed to impact upon hospital leadership, communication, organisation and safety climate. Measures A survey including a 31-item SCC scale was administered at two time-points. Results Modest but significant positive movement in SCC score was observed between the study time-points. Individual programme responsibility, availability of early adopters, multi-professional collaboration and extent of process measurement were significant predictors of change in SCC. Hospital type and size, along with a range of programme preconditions, were not found to be significant. Conclusion A range of social, cultural and organisational factors may be sensitive to this type of intervention but the measurable effect is small. Supporting critical local programme implementation factors may be an effective strategy in achieving development in organisational patient SCC, regardless of contextual factors and organisational preconditions.

The role of chief executive officers in a quality improvement initiative: a qualitative study

Objectives To identify the critical dimensions of hospital Chief Executive Officers’ (CEOs) involvement in a quality and safety initiative and to offer practical guidance to assist CEOs to fulfil their leadership role in quality improvement (QI). Design Qualitative interview study. Setting 20 organisations participating in the main phase of the Safer Patients Initiative (SPI) programme across the UK. Participants 17 CEOs overseeing 19 organisations participating in the main phase of the SPI programme and 36 staff (20 workstream leads, 10 coordinators and 6 managers) involved in SPI across all 20 participating organisations. Main outcome measure Self-reported perceptions of CEOs on their contribution and involvement within the SPI programme, supplemented by staff peer-reports. Results The CEOs recognised the importance of their part in the SPI programme and gave detailed accounts of the perceived value that their involvement had brought at all stages of the process. In exploring the parts played by the CEOs, five dimensions were identified: (1) resource provision; (2) staff motivation and engagement; (3) commitment and support; (4) monitoring progress and (5) embedding programme elements. Staff reports confirmed these dimensions; however, the weighting of the dimensions differed. The findings stress the importance of particular actions of support and monitoring such as constant communication through leadership walk rounds and reviewing programme progress and its related clinical outcomes at Board meetings. Conclusions This study addressed the call for more research-informed practical guidance on the role of senior management in QI initiatives. The findings show that the CEOs provided key participation considered to significantly contribute towards the SPI programme. CEOs and staff identified a number of clear and consistent themes essential to organisation safety improvement. Queries raised include the tangible benefits of executive involvement in changing structures and embedding for sustainability and the practical steps to creating the ‘right’ environment for QI.

Predictors of the perceived impact of a patient safety collaborative: an exploratory study.

OBJECTIVE The aim of this study was to evaluate the influence of various factors on the perceived impact of a patient safety improvement collaborative in the UK, the Safer Patients Initiative (SPI). STUDY DESIGN A cross-sectional survey design was used. Study setting Twenty National Health Service organizations from the UK that participated in the main phase of the SPI programme, which ran from September 2007 to 2008. PARTICIPANTS Senior executive leads, clinical operational leads in the four clinical areas targeted by the programme, programme coordinators and any other staff involved in the SPI (n = 635). INTERVENTION The SPI is a patient safety improvement intervention based on the Breakthrough Series Collaborative model (Institute of Healthcare Improvement, 2004) aimed at improving patient safety in four clinical areas (general ward care, intensive care, perioperative care and pharmacy) through implementing a number of evidence-based clinical practices and a focus on organizational leadership. Outcome measures Participant perceptions of the impact of the programme on their organizations. RESULTS Exploratory regression analysis showed that programme management, the value assigned to programme methodology and length of data collection contributed the largest variance in perceived impact of the SPI followed by perceived support from junior doctors, inter-professional collaboration, difference of the programme from existing safety improvement practices and organizational readiness. CONCLUSIONS The resulting model suggests hierarchical importance for a range of variables to support future research concerning the mechanisms by which large-scale organizational programmes, such as the SPI, impact on the care systems they are designed to influence.

Expanding Healthcare Failure Mode and Effect Analysis: a composite proactive risk analysis approach

Healthcare Failure Mode and Effect Analysis (HFMEA) is a systematic risk assessment method derived from high risk industries to prospectively examine complex healthcare processes. Like most methods, HFMEA has strengths and weaknesses. In this paper we provide a review of HFMEAs limitations and we introduce an expanded version of traditional HFMEA, with the addition of two safety management techniques: Systematic Human Error Reduction and Prediction Analysis (SHERPA) and Systems-Theoretic Accident Model and Processes – Systems-Theoretic Process Analysis (STAMP-STPA). The combination of the three methodologies addresses significant HFMEA limitations. To test the viability of the proposed hybrid technique, we applied it to assess the potential failures in the process of administration of medication in the home setting. Our findings suggest that it is both a viable and effective tool to supplement the analysis of failures and their causes. We also found that the hybrid technique was effective in identifying corrective actions to address human errors and detecting failures of the constraints necessary to maintain safety.

A prospective risk assessment of informal carers’ medication administration errors within the domiciliary setting

Abstract Increasingly, medication is being administered at home by family and friends of the care-recipient. This study aims to identify and analyse risks associated with potential drug administration errors made by informal carers at home. We mapped medication administration at home with a multidisciplinary team that included carers, health care professionals and patients. Evidence-based risk-analysis methodologies were applied: Healthcare Failure Modes and Effect Analysis (HFMEA), Systematic Human Error Reduction and Prediction Analysis (SHERPA) and Systems-Theoretic Accident Model and Processes (STAMP). The process of administration comprises seven sub-processes. Thirty-four possible failure modes were identified and six of these were rated as high risk. These highlighted that medications may be given with a wrong dose, stored incorrectly, not discontinued as instructed, not recorded, or not ordered on time, and often caused by communication and support problems. Combined risk analyses contributed unique information helpful to better understand the medication administration risks and causes within homecare. Practitioner Summary: Increasingly, medication is being administered at home by family and friends of the care-recipient. This study identifies risks associated with potential drug administration errors made by informal carers at home through consensus-based quantitative techniques. The different analyses contribute unique information helpful to better understand the administration risks and causes.

Carers' Medication Administration Errors in the Domiciliary Setting: A Systematic Review.

Purpose Medications are mostly taken in patients’ own homes, increasingly administered by carers, yet studies of medication safety have been largely conducted in the hospital setting. We aimed to review studies of how carers cause and/or prevent medication administration errors (MAEs) within the patient’s home; to identify types, prevalence and causes of these MAEs and any interventions to prevent them. Methods A narrative systematic review of literature published between 1 Jan 1946 and 23 Sep 2013 was carried out across the databases EMBASE, MEDLINE, PSYCHINFO, COCHRANE and CINAHL. Empirical studies were included where carers were responsible for preventing/causing MAEs in the home and standardised tools used for data extraction and quality assessment. Results Thirty-six papers met the criteria for narrative review, 33 of which included parents caring for children, two predominantly comprised adult children and spouses caring for older parents/partners, and one focused on paid carers mostly looking after older adults. The carer administration error rate ranged from 1.9 to 33% of medications administered and from 12 to 92.7% of carers administering medication. These included dosage errors, omitted administration, wrong medication and wrong time or route of administration. Contributory factors included individual carer factors (e.g. carer age), environmental factors (e.g. storage), medication factors (e.g. number of medicines), prescription communication factors (e.g. comprehensibility of instructions), psychosocial factors (e.g. carer-to-carer communication), and care-recipient factors (e.g. recipient age). The few interventions effective in preventing MAEs involved carer training and tailored equipment. Conclusion This review shows that home medication administration errors made by carers are a potentially serious patient safety issue. Carers made similar errors to those made by professionals in other contexts and a wide variety of contributory factors were identified. The home care setting should be a priority for the development of patient safety interventions.