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

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.

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.

Socio-psychological factors driving adult vaccination: a qualitative study.

BACKGROUND: While immunization is one of the most effective and successful public health interventions, there are still up to 30,000 deaths in major developed economies each year due to vaccine-preventable diseases, almost all in adults. In the UK, despite comparatively high vaccination rates among ≥65 s (73%) and, to a lesser extent, at-risk ≤65 s (52%) in 2013/2014, over 10,000 excess deaths were reported the previous influenza season. Adult tetanus vaccines are not routinely recommended in the UK, but may be overly administered. Social influences and risk-perceptions of diseases and vaccines are known to affect vaccine uptake. We aimed to explore the socio-psychological factors that drive adult vaccination in the UK, specifically influenza and tetanus, and to evaluate whether these factors are comparable between vaccines. METHODS: 20 in-depth, face-to-face interviews were conducted with members of the UK public who represented a range of socio-demographic characteristics associated with vaccination uptake. We employed qualitative interviewing approaches to reach a comprehensive understanding of the factors influencing adult vaccination decisions. Thematic analysis was used to analyze the data. RESULTS: Participants were classified according to their vaccination status as regular, intermittent and non-vaccinators for influenza, and preventative, injury-led, mixed (both preventative and injury-led) and as non-vaccinators for tetanus. We present our finding around five overarching themes: 1) perceived health and health behaviors; 2) knowledge; 3) vaccination influences; 4) disease appraisal; and 5) vaccination appraisal. CONCLUSION: The uptake of influenza and tetanus vaccines was largely driven by participants' risk perception of these diseases. The tetanus vaccine is perceived as safe and sufficiently tested, whereas the changing composition of the influenza vaccine is a cause of uncertainty and distrust. To maximize the public health impact of adult vaccines, policy should be better translated into high vaccination rates through evidence-based implementation approaches.

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.

Journey to vaccination: a protocol for a multinational qualitative study.

INTRODUCTION: In the past two decades, childhood vaccination coverage has increased dramatically, averting an estimated 2-3 million deaths per year. Adult vaccination coverage, however, remains inconsistently recorded and substandard. Although structural barriers are known to limit coverage, social and psychological factors can also affect vaccine uptake. Previous qualitative studies have explored beliefs, attitudes and preferences associated with seasonal influenza (flu) vaccination uptake, yet little research has investigated how participants' context and experiences influence their vaccination decision-making process over time. This paper aims to provide a detailed account of a mixed methods approach designed to understand the wider constellation of social and psychological factors likely to influence adult vaccination decisions, as well as the context in which these decisions take place, in the USA, the UK, France, India, China and Brazil. METHODS AND ANALYSIS: We employ a combination of qualitative interviewing approaches to reach a comprehensive understanding of the factors influencing vaccination decisions, specifically seasonal flu and tetanus. To elicit these factors, we developed the journey to vaccination, a new qualitative approach anchored on the heuristics and biases tradition and the customer journey mapping approach. A purposive sampling strategy is used to select participants who represent a range of key sociodemographic characteristics. Thematic analysis will be used to analyse the data. Typical journeys to vaccination will be proposed. ETHICS AND DISSEMINATION: Vaccination uptake is significantly influenced by social and psychological factors, some of which are under-reported and poorly understood. This research will provide a deeper understanding of the barriers and drivers to adult vaccination. Our findings will be published in relevant peer-reviewed journals and presented at academic conferences. They will also be presented as practical recommendations at policy and industry meetings and healthcare professionals' forums. This research was approved by relevant local ethics committees.

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

OBJECTIVES: To identify the critical dimensions of hospital Chief Executive Officers' (CEOs) involvement in a quality and safety 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 s. 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.

Strategies for sustaining a quality improvement collaborative and its patient safety gains.

OBJECTIVE: To identify strategies to facilitate the sustainability of a quality and safety improvement collaborative: the Safer Patients Initiative (SPI) and its successes. DESIGN: A qualitative interview study with a repeated sample at two time points. SETTING: Twenty organizations participating in the SPI programme in the UK. PARTICIPANTS: Twenty principal SPI programme coordinators took part in interviews towards the end of the supported phase of the programme, 12 of which were interviewed again a year later, along with another three replacement programme coordinators, totalling 35 interviewees across the two time points. MAIN OUTCOME MEASURES: Programme coordinators' perceptions of facilitating strategies to the sustainability of the collaborative and its gains. RESULTS: Qualitative analysis identified three overarching factors for the sustainability of SPI: (i) using programme improvement methodology and measurement of its outcomes; (ii) organizational strategies to ensure sustainability and (iii) alignment of goals with external requirements. Within these were eight themes identified by the coordinators as helping to sustain the efforts of the SPI programme and its successes. CONCLUSIONS: This study has presented what principle programme coordinators across 20 NHS organizations considered to be the key strategies to sustain their own improvement programme and its successes, during the supported phase of the programme and 1 year on. Recommendations are to consider these practical strategies in order to improve chances of maintaining changes and continuing a quality improvement programme beyond the formal cessation of the intervention.

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.

Failure Mode and Effects Analysis: views of hospital staff in the UK.

OBJECTIVE: To explore health care professionals' experiences and perceptions of Failure Mode and Effects Analysis (FMEA), a team-based, prospective risk analysis technique. METHODS: Semi-structured interviews were conducted with 21 operational leads (20 pharmacists, one nurse) in medicines management teams of hospitals participating in a national quality improvement programme. Interviews were transcribed, coded and emergent themes identified using framework analysis. RESULTS: Themes identified included perceptions and experiences of participants with FMEA, validity and reliability issues, and FMEA's use in practice. FMEA was considered to be a structured but subjective process that helps health care professionals get together to identify high risk areas of care. Both positive and negative opinions were expressed, with the majority of interviewees expressing positive views towards FMEA in relation to its structured nature and the use of a multidisciplinary team. Other participants criticised FMEA for being subjective and lacking validity. Most likely to restrict its widespread use were its time consuming nature and its perceived lack of validity and reliability. CONCLUSION: FMEA is a subjective but systematic tool that helps identify high risk areas, but its time consuming nature, difficulty with the scores and perceived lack of validity and reliability may limit its widespread use.

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.

Improving reliability of clinical care practices for ventilated patients in the context of a patient safety improvement initiative.

AIMS: To investigate perceived factors relating to the reliable application of four clinical care practices targeting ventilator-associated pneumonias, in the context of a patient safety improvement initiative called the Safer Patients Initiative (SPI). METHODS: Qualitative case study. Seventeen semi-structured individual interviews with clinical operational leads, programme coordinators and executive managers who were involved in the implementation of the programme's critical care work stream during its pilot phase. The interviews had a focus on perceived aspects pertaining to the reliable implementation of the four clinical practices, promoted by the Institute for Healthcare Improvement as the 'ventilator care bundle'. RESULTS: Thematic analysis of the verbatim transcripts revealed three overarching themes experienced by the participants during the implementation of the clinical practices included in the SPI ventilator care bundle: the power of measurement, feedback to peers and experts and improvement tools specific to SPI. Consistent measurement of compliance with the four elements of the bundle and outcomes made the staff realize that their engagement in previous improvement work for ventilated patients was inadequate and motivated them to apply the introduced clinical practices more reliably. Feedback to experts and peers of staff compliance with the four clinical practices and outcome improvement was perceived as a very influential aspect of SPI. Small tests of change (Plan-Do-Study-Act cycles), teaching sessions and daily goal sheets were quoted as particularly useful tools throughout the implementation of the four clinical care practices. CONCLUSIONS: Future initiatives that aim to improve the adherence of clinical staff with clinical practice guidelines in intensive care units could benefit from integrating in their methodology consistent measurement and feedback practices of both process compliance and outcome data.

The disparity of frontline clinical staff and managers' perceptions of a quality and patient safety initiative.

RATIONALE, AIMS AND OBJECTIVES: Arguably, a shared perspective between managers and their clinical staff on an improvement initiative would allow for most effective implementation and increase programme success. However, it has been reported that research has failed to differentiate between managers and line employees on quality management implementation and examine their differences in perceptions of quality and safety initiatives. The aim of this study was to compare clinical frontline staff and senior managers' perceptions on the importance of an organization-wide quality and safety collaborative: the Safer Patients Initiative (SPI). METHOD: A quantitative study obtained 635 surveys at 20 trusts participating in SPI. Participants included the teams and frontline staff involved within the programme at each organization. Independent T-tests were carried out between frontline staff and senior managers' perceptions of SPI programme elements, success factors and impact & sustainability. RESULTS: Statistically significant differences were found between the perceptions of frontline staff and senior managers on a wide number of issues, including the frontline perceiving a significantly larger improvement on the timeliness of care delivery (t = 2.943, P = 0.004), while managers perceived larger improvement on the culture within the organization for safe, effective and reliable care (t = -2.454, P = 0.014). CONCLUSION: This study has identified statistically significant disparities in perceptions of an organization-wide improvement initiative between frontline staff and senior managers. This holds valuable implications for the importance of getting both frontline and management perspectives when designing such interventions, in monitoring their performance, and in evaluating their impact.

Medical engagement in organisation-wide safety and quality-improvement programmes: experience in the UK Safer Patients Initiative.

OBJECTIVES: To identify factors affecting doctors' engagement with the Safer Patients Initiative (SPI). DESIGN: Qualitative interview study. SETTING: Four organisations participating in phase 1 of the SPI programme, from four different geographical locations in the UK. PARTICIPANTS: 34 staff members, comprising senior executive/management leads involved in the SPI programme, the principal SPI programme coordinator and the operational leads in each of the SPI clinical work areas. MAIN OUTCOME MEASURES: Staff perceptions of issues affecting medical engagement with SPI, identified in the interviews. RESULTS: Qualitative analysis identified seven factors that were reported to affect medical engagement with the SPI programme: (1) Organisation Track Record in QSI, (2) Resource Availability & Allocation, (3) Perceptions of the purpose of SPI, (4) Evidence of Efficacy of Programme, (5) External Expertise, (6) Local Programme Champions and (7) Managers Involvement. Specific barriers and general enabling strategies were identified and described for each factor, based upon participants' experiences. CONCLUSIONS: Medical engagement is a complex technical, socio-political and motivational issue that is underpinned by a series of inter-related factors associated with the organisational context, the design of improvement programmes and how they are implemented and promoted. Healthcare organisations planning to embark on safety and quality-improvement programmes may benefit from systematically addressing the core themes identified by this study, in order to promote optimal medical engagement.

Organisational readiness: exploring the preconditions for success in organisation-wide patient safety improvement programmes.

BACKGROUND: Patient safety has been high on the agenda for more than a decade. Despite many national initiatives aimed at improving patient safety, the challenge remains to find coherent and sustainable organisation-wide safety-improvement programmes. In the UK, the Safer Patients' Initiative (SPI) was established to address this challenge. Important in the success of such an endeavour is understanding 'readiness' at the organisational level, identifying the preconditions for success in this type of programme. This article reports on a case study of the four NHS organisations participating in the first phase of SPI, examining the perceptions of organisational readiness and the relationship of these factors with impact by those actively involved in the initiative. MATERIALS AND METHODS: A mixed-methods design was used, involving a survey and semistructured interviews with senior executive leads, the principal SPI programme coordinator and the four operational leads in each of the SPI clinical work areas in all four organisations taking part in the first phase of SPI. CONCLUSIONS: This preliminary work would suggest that prior to the start of organisation-wide quality- and safety-improvement programmes, organisations would benefit from an assessment of readiness with time spent in the preparation of the organisational infrastructure, processes and culture. Furthermore, a better understanding of the preconditions that mark an organisation as ready for improvement work would allow policymakers to set realistic expectations about the outcomes of safety campaigns.

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.

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 Foundation's 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 participant's 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.