Experience-based co-design-Adapting the method for a researcher-initiated study in a multi-site setting.

BACKGROUND: Experience-based co-design (EBCD) brings patients and staff together to co-design services. It is normally conducted in one organization which initiates and implements the process. We used the traditional EBCD method with a number of adaptations as part of a larger research study in the British National Health Service. METHODS: The primary aim was to assess the feasibility and acceptability of conducting research-initiated EBCD, to enhance intervention development prior to testing. As well as embedding the method in a research study, there were 3 further key adaptations: (a) working across primary and secondary care sectors, (b) working on multiple sites and (c) incorporating theory-informed analysis. RESULTS: We recruited four sites (covering both primary and secondary care) and, on each site, conducted the initial traditional EBCD meetings, with separate staff and patient groups-followed by a single joint patient-staff event, where four priority areas for co-design were agreed. This event was driven by theory-informed analysis, as well as the traditional trigger film of patient experiences. Each site worked on one priority area, and the four co-design groups met over 2-3 months to design prototype tools. A second joint event was held (not usually undertaken in single-site EBCD) where they shared and compared outputs. The research team combined elements of these outputs to create an intervention, now being tested in a cluster randomized controlled trial. CONCLUSIONS: EBCD can be successfully adapted for use across an entire patient pathway with multiple organizations and as part of a research process to identify an intervention for subsequent testing in a randomized trial. Our pragmatic approach used the patient experience to identify areas for improvement and co-designed an intervention which directly reflected patient priorities.

The patient reporting and action for a safe environment (PRASE) intervention: a feasibility study.

BACKGROUND: There is growing interest in the role of patients in improving patient safety. One such role is providing feedback on the safety of their care. Here we describe the development and feasibility testing of an intervention that collects patient feedback on patient safety, brings together staff to consider this feedback and to plan improvement strategies. We address two research questions: i) to explore the feasibility of the process of systematically collecting feedback from patients about the safety of care as part of the PRASE intervention; and, ii) to explore the feasibility and acceptability of the PRASE intervention for staff, and to understand more about how staff use the patient feedback for service improvement. METHOD: We conducted a feasibility study using a wait-list controlled design across six wards within an acute teaching hospital. Intervention wards were asked to participate in two cycles of the PRASE (Patient Reporting & Action for a Safe Environment) intervention across a six-month period. Participants were patients on participating wards. To explore the acceptability of the intervention for staff, observations of action planning meetings, interviews with a lead person for the intervention on each ward and recorded researcher reflections were analysed thematically and synthesised. RESULTS: Recruitment of patients using computer tablets at their bedside was straightforward, with the majority of patients willing and able to provide feedback. Randomisation of the intervention was acceptable to staff, with no evidence of differential response rates between intervention and control groups. In general, ward staff were positive about the use of patient feedback for service improvement and were able to use the feedback as a basis for action planning, although engagement with the process was variable. Gathering a multidisciplinary team together for action planning was found to be challenging, and implementing action plans was sometimes hindered by the need to co-ordinate action across multiple services. DISCUSSION: The PRASE intervention was found to be acceptable to staff and patients. However, before proceeding to a full cluster randomised controlled trial, the intervention requires adaptation to account for the difficulties in implementing action plans within three months, the need for a facilitator to support the action planning meetings, and the provision of training and senior management support for participating ward teams. CONCLUSIONS: The PRASE intervention represents a promising method for the systematic collection of patient feedback about the safety of hospital care.

The process and perspective of serious incident investigations in adult community mental health services: integrative review and synthesis.

AIMS AND METHOD: Serious incident management and organisational learning are international patient safety priorities. Little is known about the quality of suicide investigations and, in turn, the potential for organisational learning. Suicide risk assessment is acknowledged as a complex phenomenon, particularly in the context of adult community mental health services. Root cause analysis (RCA) is the dominant investigative approach, although the evidence base underpinning RCA is contested, with little attention paid to the patient in context and their cumulative risk over time. RESULTS: Recent literature proposes a safety-II approach in response to the limitations of RCA. The importance of applying these approaches within a mental healthcare system that advocates a zero suicide framework, grounded in a restorative just culture, is highlighted. CLINICAL IMPLICATIONS: Although integrative reviews and syntheses have clear methodological limitations, this approach facilitates the management of a disparate body of work to advance a critical understanding of patient safety in adult community mental healthcare.

Patient involvement in patient safety: Protocol for developing an intervention using patient reports of organisational safety and patient incident reporting.

BACKGROUND: Patients have the potential to provide a rich source of information on both organisational aspects of safety and patient safety incidents. This project aims to develop two patient safety interventions to promote organisational learning about safety - a patient measure of organisational safety (PMOS), and a patient incident reporting tool (PIRT) - to help the NHS prevent patient safety incidents by learning more about when and why they occur. METHODS: To develop the PMOS 1) literature will be reviewed to identify similar measures and key contributory factors to error; 2) four patient focus groups will ascertain practicality and feasibility; 3) 25 patient interviews will elicit approximately 60 items across 10 domains; 4) 10 patient and clinician interviews will test acceptability and understanding. Qualitative data will be analysed using thematic content analysis.To develop the PIRT 1) individual and then combined patient and clinician focus groups will provide guidance for the development of three potential reporting tools; 2) nine wards across three hospital directorates will pilot each of the tools for three months. The best performing tool will be identified from the frequency, volume and quality of reports. The validity of both measures will be tested. 300 patients will be asked to complete the PMOS and PIRT during their stay in hospital. A sub-sample (N = 50) will complete the PMOS again one week later. Health professionals in participating wards will also be asked to complete the AHRQ safety culture questionnaire. Case notes for all patients will be reviewed. The psychometric properties of the PMOS will be assessed and a final valid and reliable version developed. Concurrent validity for the PIRT will be assessed by comparing reported incidents with those identified from case note review and the existing staff reporting scheme. In a subsequent study these tools will be used to provide information to wards/units about their priorities for patient safety. A patient panel will provide steering to the research. DISCUSSION: The PMOS and PIRT aim to provide a reliable means of eliciting patient views about patient safety. Both interventions are likely to have relevance and practical utility for all NHS hospital trusts.

Twelve tips for implementing a patient safety curriculum in an undergraduate programme in medicine.

Patient safety is a major priority for health services. It is a multi-disciplinary problem and requires a multi-disciplinary solution; any education should therefore be a multi-disciplinary endeavour, from conception to implementation. The starting point should be at undergraduate level and medical education should not be an exception. It is apparent that current educational provision in patient safety lacks a systematic approach, is not linked to formal assessment and is detached from the reality of practice. If patient safety education is to be fit for purpose, it should link theory and the reality of practice; a human factors approach offers a framework to create this linkage. Learning outcomes should be competency based and generic content explicitly linked to specific patient safety content. Students should ultimately be able to demonstrate the impact of what they learn in improving their clinical performance. It is essential that the patient safety curriculum spans the entire undergraduate programme; we argue here for a spiral model incorporating innovative, multi-method assessment which examines knowledge, skills, attitudes and values. Students are increasingly learning from patient experiences, we advocate learning directly from patients wherever possible. Undergraduate provision should provide a platform for continuing education in patient safety, all of which should be subject to periodic evaluation with a particular emphasis on practice impact.

A practical guide to failure mode and effects analysis in health care: making the most of the team and its meetings.

BACKGROUND: Failure Mode and Effects Analysis (FMEA) is a proactive risk assessment tool used to identify potential vulnerabilities in complex, high-risk processes and to generate remedial actions before the processes result in adverse events. FMEA is increasingly used to proactively assess and improve the safety of complex health care processes such as drug administration and blood transfusion. A central feature of FMEA is that it is undertaken by a multidisciplinary team, and because it entails numerous analytical steps, it takes a series of several meetings. Composing a team of busy health care professionals with the appropriate knowledge, skill mix, and logistical availability for regular meetings is, however, a serious challenge. Despite this, information and advice on FMEA team assembly and meetings scheduling are scarce and diffuse and often presented without the accompanying rationale. THE MULTIDISCIPLINARY TEAM: Assemble an eight-member team composed of clinically active health care staff, from every profession involved in delivery of the process-and who regularly perform it; staff from a range of seniority levels; outsider(s) to the process-and perhaps even to health care; a leader (and facilitator); and researchers. SCHEDULING: Plan for 10-15 hours of team meeting time for first-time, narrowly defined FMEAs, scheduled as four to six meetings lasting 2 to 3 hours each, spaced weekly to biweekly. Meet in a venue that seats the team around one table and is off the hospital floor but within its grounds. CONCLUSIONS: FMEA, generally acknowledged to be a useful addition to the patient safety toolkit, is a meticulous and time- and resource-intensive methodology, and its successful completion is highly dependent on the team members' aptitude and on the facility's and team members' commitment to hold regular, productive meetings.

Medical error in the hospice setting: exploring the perspectives of management staff.

This study explores the experiences of health professionals in managerial roles at various levels in child and adult hospice care in northern England, studying perspectives around managing medical error, the issues that arise, and the challenges faced. A multicentred, descriptive, exploratory design was adopted. The sample comprised 10 hospice managers (five deputy and five senior managers) from four hospices (two adult and two children's) in the north of England. Participants took part in individual semi-structured interviews, which lasted between 45-60 minutes each. Interviews were transcribed and analysed by a team of three researchers, including two health psychologists and one nurse using a qualitative analytic framework. Emerging themes appeared to be inter-related and were ultimately linked to two meta-concepts; underpinning and fundamental to the data, these issues were intrinsically tied to all emerging themes. Primary themes were defined by their explanatory power and regularity. Primary themes highlighted the impact of managing error on management teams at a professional and personal level, the challenges for error management in hospice settings, the use of error management tools, and the conceptualization of blame in these settings. The strong influence of the health-care setting in which an error takes place on the outcomes of an error event for the health professional, managers, health-care organizations, and ultimately patients was evident.

Human error theory: relevance to nurse management.

AIM: Describe, discuss and critically appraise human error theory and consider its relevance for nurse managers. BACKGROUND: Healthcare errors are a persistent threat to patient safety. Effective risk management and clinical governance depends on understanding the nature of error. EVALUATION: This paper draws upon a wide literature from published works, largely from the field of cognitive psychology and human factors. Although the content of this paper is pertinent to any healthcare professional; it is written primarily for nurse managers. KEY ISSUES: Error is inevitable. Causation is often attributed to individuals, yet causation in complex environments such as healthcare is predominantly multi-factorial. Individual performance is affected by the tendency to develop prepacked solutions and attention deficits, which can in turn be related to local conditions and systems or latent failures. Blame is often inappropriate. Defences should be constructed in the light of these considerations and to promote error wisdom and organizational resilience. CONCLUSION AND IMPLICATIONS: Managing and learning from error is seen as a priority in the British National Health Service (NHS), this can be better achieved with an understanding of the roots, nature and consequences of error. Such an understanding can provide a helpful framework for a range of risk management activities.

The risks of double checking.

For many healthcare professionals, particularly nurses, double checking medications is part of the daily routine. However, a study of medication errors and how they are reported (Armitage 2003) reveals that double checking sometimes contributes to medication errors. This article describes how reasons for this can be gleaned from human error theory, and claims that a solution to the problem may lie in the aviation industry.

Cardiology patients' medicines management networks after hospital discharge: A mixed methods analysis of a complex adaptive system.

INTRODUCTION: The complex healthcare system that provides patients with medicines places them at risk when care is transferred between healthcare organisations, for example discharge from hospital. Consequently, understanding and improving medicines management, particularly at care transfers, is a priority. OBJECTIVES: This study aimed to explore the medicines management system as patients experience it and determine differences in the patient-perceived importance of people in the system. METHODS: We used a Social Network Analysis framework, collecting ego-net data about the importance of people patients had contact with concerning their medicines after hospital discharge. Single- and multi-level logistic regression models of patients' networks were constructed, and model residuals were explored at the patient level. This enabled us to identify patients' networks with support tie patterns different from the general patterns suggested by the model results. Qualitative data for those patients were then analysed to understand their differing experiences. RESULTS: Networks comprised clinical and administrative healthcare staff and friends and family members. Networks were highly individual and the perceived importance of alters varied both within and between patients. Ties to spouses were significantly more likely to be rated as highly important and ties to community pharmacy staff (other than pharmacists) and to GP receptionists were less likely to be highly rated. Patients with low-value medicines management networks described having limited information about their medicines and a lack of understanding or help. Patients with high-value networks described appreciating support and having confidence in staff. CONCLUSIONS: Patients experienced medicines management as individual systems within which they interacted with healthcare staff and informal support to manage their treatment. Multilevel models indicated that there are unexplained variables impacting on patients' assessments of their medicines management networks. Qualitative exploration of the model residuals can offer an understanding of networks that do not have the typical range of support ties.

Gaps, traps, bridges and props: a mixed-methods study of resilience in the medicines management system for patients with heart failure at hospital discharge.

INTRODUCTION: Poor medicines management places patients at risk, particularly during care transitions. For patients with heart failure (HF), optimal medicines management is crucial to control symptoms and prevent hospital readmission. This study explored the concept of resilience using HF as an example condition to understand how the system compensates for known and unknown weaknesses. METHODS: We explored resilience using a mixed-methods approach in four healthcare economies in the north of England. Data from hospital site observations, healthcare staff and patient interviews, and documentary analysis were collected between June 2016 and March 2017. Data were synthesised and analysed using framework analysis. RESULTS: Interviews were conducted with 45 healthcare professionals, with 20 patients at three time points and 189 hours of observation were undertaken. We identified four primary inter-related themes concerning organisational resilience. These were named as gaps, traps, bridges and props. Gaps were discontinuities in processes that had the potential to result in poorly optimised medicines. Traps were features of the system that could produce errors or unintended adverse medication events. Bridges were features of the medicines management system that promoted safety and continuity which ensured that, despite varying conditions, care could be delivered successfully. Props were informal, temporary or impromptu actions taken by patients or healthcare staff to avoid potential adverse events. CONCLUSION: The numerous opportunities for HF patient safety to be compromised and for suboptimal medicines management during this common care transition are mitigated by system resilience. Cross-organisational bridges and temporary fixes or 'props' put in place by patients and carers, healthcare teams and organisations are critical for safe and optimal care to be delivered in the face of continued system pressures.

A qualitative study of patient involvement in medicines management after hospital discharge: an under-recognised source of systems resilience.

INTRODUCTION: There are risks to the safety of medicines management when patient care is transferred between healthcare organisations, for example, when a patient is discharged from hospital. Using the theoretical concept of resilience in healthcare, this study aimed to better understand the proactive role that patients can play in creating safer, resilient medicines management at a common transition of care. METHODS: Qualitative interviews with 60 cardiology patients 6 weeks after their discharge from 2 UK hospitals explored patients' experiences with their discharge medicines. Data were initially subjected to an inductive thematic analysis and a subsequent theory-guided deductive analysis. RESULTS: During interviews 23 patients described medicines management resilience strategies in two main themes: identifying system vulnerabilities; and establishing self-management strategies. Patients could anticipate problems in the system that supplied them with medicines and took specific actions to prevent them. They also identified when errors had occurred both before and after medicines had been supplied and took corrective action to avoid harm. Some reported how they had not foreseen problems or experienced patient safety incidents. Patients recounted how they ensured information about medicines changes was correctly communicated and acted upon, and described their strategies to enhance their own reliability in adherence and resource management. CONCLUSION: Patients experience the impact of vulnerabilities in the medicines management system across the secondary-primary care transition but many are able to enhance system resilience through developing strategies to reduce the risk of medicines errors occurring. Consequently, there are opportunities-with caveats-to elicit, develop and formalise patients' capabilities which would contribute to safer patient care and more effective medicines management.

Patient-reported safety incidents as a new source of patient safety data: an exploratory comparative study in an acute hospital in England.

Objectives To compare a new co-designed, patient incident reporting tool with three established methods of detecting patient safety incidents and identify if the same incidents are recorded across methods. Method Trained research staff collected data from inpatients in nine wards in one university teaching hospital during their stay. Those classified as patient safety incidents were retained. We then searched for patient safety incidents in the corresponding patient case notes, staff incident reports and reports to the Patient Advice and Liaison Service specific to the study wards. Results In the nine wards, 329 patients were recruited to the study, of which 77 provided 155 patient reports. From these, 68 patient safety incidents were identified. Eight of these were also identified from case note review, five were also identified in incident reports, and two were also found in the records of a local Patient Advice and Liaison Service. Reports of patients covered a range of events from their immediate environment, involving different health professionals and spanning the entire spectrum of care. Conclusion Patient safety incidents reported by patients are unlikely to be found through other established methods of incident detection. When hospitalized patients are asked about their care, they can provide a unique perspective on patient safety. Co-designed, real-time reporting could be a helpful addition to existing methods of gathering patient safety intelligence.

What can patients tell us about the quality and safety of hospital care? Findings from a UK multicentre survey study.

BACKGROUND: Patient safety measurement remains a global challenge. Patients are an important but neglected source of learning; however, little is known about what patients can add to our understanding of safety. We sought to understand the incidence and nature of patient-reported safety concerns in hospital. METHODS: Feedback about the experience of safety within hospital was gathered from 2471 inpatients as part of a multicentre, waitlist cluster randomised controlled trial of an intervention, undertaken within 33 wards across three English NHS Trusts, between May 2013 and September 2014. Patient volunteers, supported by researchers, developed a classification framework of patient-reported safety concerns from a random sample of 231 reports. All reports were then classified using the patient-developed categories. Following this, all patient-reported safety concerns underwent a two-stage clinical review process for identification of patient safety incidents. RESULTS: Of the 2471 inpatients recruited, 579 provided 1155 patient-reported incident reports. 14 categories were developed for classification of reports, with communication the most frequently occurring (22%), followed by staffing issues (13%) and problems with the care environment (12%). 406 of the total 1155 patient incident reports (35%) were classified by clinicians as a patient safety incident according to the standard definition. 1 in 10 patients (264 patients) identified a patient safety incident, with medication errors the most frequently reported incident. CONCLUSIONS: Our findings suggest that patients can provide insight about safety that complements existing patient safety measurement, with a frequency of reported patient safety incidents that is similar to those obtained via case note review. However, patients provide a unique perspective about hospital safety which differs from and adds to current definitions of patient safety incidents. TRIAL REGISTRATION NUMBER: ISRCTN07689702; pre-results.

Recognising and referring children exposed to domestic abuse: a multi-professional, proactive systems-based evaluation using a modified Failure Mode and Effects Analysis (FMEA).

Failure Modes and Effects Analysis (FMEA) is a prospective quality assurance methodology increasingly used in healthcare, which identifies potential vulnerabilities in complex, high-risk processes and generates remedial actions. We aimed, for the first time, to apply FMEA in a social care context to evaluate the process for recognising and referring children exposed to domestic abuse within one Midlands city safeguarding area in England. A multidisciplinary, multi-agency team of 10 front-line professionals undertook the FMEA, using a modified methodology, over seven group meetings. The FMEA included mapping out the process under evaluation to identify its component steps, identifying failure modes (potential errors) and possible causes for each step and generating corrective actions. In this article, we report the output from the FMEA, including illustrative examples of the failure modes and corrective actions generated. We also present an analysis of feedback from the FMEA team and provide future recommendations for the use of FMEA in appraising social care processes and practice. Although challenging, the FMEA was unequivocally valuable for team members and generated a significant number of corrective actions locally for the safeguarding board to consider in its response to children exposed to domestic abuse.

Developing a patient-led electronic feedback system for quality and safety within Renal PatientView.

BACKGROUND: It is increasingly acknowledged that patients can provide direct feedback about the quality and safety of their care through patient reporting systems. The aim of this study was to explore the feasibility of patients, healthcare professionals and researchers working in partnership to develop a patient-led quality and safety feedback system within an existing electronic health record (EHR), known as Renal PatientView (RPV). METHODS: Phase 1 (inception) involved focus groups (n = 9) and phase 2 (requirements) involved cognitive walkthroughs (n = 34) and 1:1 qualitative interviews (n = 34) with patients and healthcare professionals. A Joint Services Expert Panel (JSP) was convened to review the findings from phase 1 and agree the core principles and components of the system prototype. Phase 1 data were analysed using a thematic approach. Data from phase 1 were used to inform the design of the initial system prototype. Phase 2 data were analysed using the components of heuristic evaluation, resulting in a list of core principles and components for the final system prototype. RESULTS: Phase 1 identified four main barriers and facilitators to patients feeding back on quality and safety concerns. In phase 2, the JSP agreed that the system should be based on seven core principles and components. DISCUSSION: Stakeholders were able to work together to identify core principles and components for an electronic patient quality and safety feedback system in renal services. Tensions arose due to competing priorities, particularly around anonymity and feedback. Careful consideration should be given to the feasibility of integrating a novel element with differing priorities into an established system with existing functions and objectives.

The Patient Feedback Response Framework - Understanding why UK hospital staff find it difficult to make improvements based on patient feedback: A qualitative study.

Patients are increasingly being asked for feedback about their healthcare experiences. However, healthcare staff often find it difficult to act on this feedback in order to make improvements to services. This paper draws upon notions of legitimacy and readiness to develop a conceptual framework (Patient Feedback Response Framework - PFRF) which outlines why staff may find it problematic to respond to patient feedback. A large qualitative study was conducted with 17 ward based teams between 2013 and 2014, across three hospital Trusts in the North of England. This was a process evaluation of a wider study where ward staff were encouraged to make action plans based on patient feedback. We focus on three methods here: i) examination of taped discussion between ward staff during action planning meetings ii) facilitators notes of these meetings iii) telephone interviews with staff focusing on whether action plans had been achieved six months later. Analysis employed an abductive approach. Through the development of the PFRF, we found that making changes based on patient feedback is a complex multi-tiered process and not something that ward staff can simply 'do'. First, staff must exhibit normative legitimacy - the belief that listening to patients is a worthwhile exercise. Second, structural legitimacy has to be in place - ward teams need adequate autonomy, ownership and resource to enact change. Some ward teams are able to make improvements within their immediate control and environment. Third, for those staff who require interdepartmental co-operation or high level assistance to achieve change, organisational readiness must exist at the level of the hospital otherwise improvement will rarely be enacted. Case studies drawn from our empirical data demonstrate the above. It is only when appropriate levels of individual and organisational capacity to change exist, that patient feedback is likely to be acted upon to improve services.

How might health services capture patient-reported safety concerns in a hospital setting? An exploratory pilot study of three mechanisms.

INTRODUCTION: Emergent evidence suggests that patients can identify and report safety issues while in hospital. However, little is known about the best method for collecting information from patients about safety concerns. This study presents an exploratory pilot of three mechanisms for collecting data on safety concerns from patients during their hospital stay. METHOD: Three mechanisms for capturing safety concerns were coproduced with healthcare professionals and patients, before being tested in an exploratory trial using cluster randomisation at the ward level. Nine wards participated, with each mechanism being tested over a 3-month study period. Patients were asked to feed back safety concerns via the mechanism on their ward (interviewing at their bedside, paper-based form or patient safety 'hotline'). Safety concerns were subjected to a two-stage review process to identify those that would meet the definition of a patient safety incident. Differences between mechanisms on a range of outcomes were analysed using inferential statistics. Safety concerns were thematically analysed to develop reporting categories. RESULTS: 178 patients were recruited. Patients in the face-to-face interviewing condition provided significantly more safety concerns per patient (1.91) compared with the paper-based form (0.92) and the patient safety hotline (0.43). They were also significantly more likely to report one or more concerns, with 64% reporting via the face-to-face mechanism, compared with 41% via the paper-based form and 19% via the patient safety hotline. No mechanism differed significantly in the number of classified patient safety incidents or physician-rated preventability and severity. DISCUSSION: Interviewing at the patient's bedside is likely to be the most effective means of gathering safety concerns from inpatients, potentially providing an opportunity for health services to gather patient feedback about safety from their perspective.