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.

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.

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.

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.

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.

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.

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.

Exploring how ward staff engage with the implementation of a patient safety intervention: a UK-based qualitative process evaluation.

OBJECTIVES: A patient safety intervention was tested in a 33-ward randomised controlled trial. No statistically significant difference between intervention and control wards was found. We conducted a process evaluation of the trial and our aim in this paper is to understand staff engagement across the 17 intervention wards. DESIGN: Large qualitative process evaluation of the implementation of a patient safety intervention. SETTING AND PARTICIPANTS: National Health Service staff based on 17 acute hospital wards located at five hospital sites in the North of England. DATA: We concentrate on three sources here: (1) analysis of taped discussion between ward staff during action planning meetings; (2) facilitators' field notes and (3) follow-up telephone interviews with staff focusing on whether action plans had been achieved. The analysis involved the use of pen portraits and adaptive theory. FINDINGS: First, there were palpable differences in the ways that the 17 ward teams engaged with the key components of the intervention. Five main engagement typologies were evident across the life course of the study: consistent, partial, increasing, decreasing and disengaged. Second, the intensity of support for the intervention at the level of the organisation does not predict the strength of engagement at the level of the individual ward team. Third, the standardisation of facilitative processes provided by the research team does not ensure that implementation standardisation of the intervention occurs by ward staff. CONCLUSIONS: A dilution of the intervention occurred during the trial because wards engaged with Patient Reporting and Action for a Safe Environment (PRASE) in divergent ways, despite the standardisation of key components. Facilitative processes were not sufficiently adequate to enable intervention wards to successfully engage with PRASE components.

Can patient involvement improve patient safety? A cluster randomised control trial of the Patient Reporting and Action for a Safe Environment (PRASE) intervention.

OBJECTIVE: To evaluate the efficacy of the Patient Reporting and Action for a Safe Environment intervention. DESIGN: A multicentre cluster randomised controlled trial. SETTING: Clusters were 33 hospital wards within five hospitals in the UK. PARTICIPANTS: All patients able to give informed consent were eligible to take part. Wards were allocated to the intervention or control condition. INTERVENTION: The ward-level intervention comprised two tools: (1) a questionnaire that asked patients about factors contributing to safety (patient measure of safety (PMOS)) and (2) a proforma for patients to report both safety concerns and positive experiences (patient incident reporting tool). Feedback was considered in multidisciplinary action planning meetings. MEASUREMENTS: Primary outcomes were routinely collected ward-level harm-free care (HFC) scores and patient-level feedback on safety (PMOS). RESULTS: Intervention uptake and retention of wards was 100% and patient participation was high (86%). We found no significant effect of the intervention on any outcomes at 6 or 12 months. However, for new harms (ie, those for which the wards were directly accountable) intervention wards did show greater, though non-significant, improvement compared with control wards. Analyses also indicated that improvements were largest for wards that showed the greatest compliance with the intervention. LIMITATIONS: Adherence to the intervention, particularly the implementation of action plans, was poor. Patient safety outcomes may represent too blunt a measure. CONCLUSIONS: Patients are willing to provide feedback about the safety of their care. However, we were unable to demonstrate any overall effect of this intervention on either measure of patient safety and therefore cannot recommend this intervention for wider uptake. Findings indicate promise for increasing HFC where wards implement ≥75% of the intervention components. TRIAL REGISTRATION NUMBER: ISRCTN07689702; pre-results.

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.

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.

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.

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.

Can staff and patient perspectives on hospital safety predict harm-free care? An analysis of staff and patient survey data and routinely collected outcomes.

BACKGROUND: Patients have the potential to provide feedback on the safety of their care. Recently, tools have been developed that ask patients to provide feedback on those factors that are known to contribute to safety, therefore providing information that can be used proactively to manage safety in hospitals. The aim of this study was to investigate whether the safety information provided by patients is different from that provided by staff and whether it is related to safety outcomes. METHOD: Data were collected from 33 hospital wards across 3 acute hospital Trusts in the UK. Staff on these wards were asked to complete the four outcome measures of the Hospital Survey of Patient Safety Culture, while patients were asked to complete the Patient Measure of Safety and the friends and family test. We also collated publicly reported safety outcome data for 'harm-free care' on each ward. This patient safety thermometer measure is used in the UK NHS to record the percentage of patients on a single day of each month on every ward who have received harm-free care (ie, no pressure ulcers, falls, urinary tract infections and hospital acquired new venous thromboembolisms). These data were used to address questions about the relationship between measures and the extent to which patient and staff perceptions of safety predict safety outcomes. RESULTS: The friends and family test, a single item measure of patient experience was associated with patients' perceptions of safety, but was not associated with safety outcomes. Staff responses to the patient safety culture survey were not significantly correlated with patient responses to the patient measure of safety, but both independently predicted safety outcomes. The regression models showed that staff perceptions (adjusted r(2)=0.39) and patient perceptions (adjusted r(2)=0.30) of safety independently predicted safety outcomes. When entered together both measures accounted for 49% of the variance in safety outcomes (adjusted r(2)=0.49), suggesting that there is overlap but some unique variance is also explained by these two measures. Based on responses to the Patient Measure of Safety it was also possible to identify differences between the acute Hospital Trusts. DISCUSSION: The findings suggest that although the views of patients and staff predict some overlapping variance in patient safety outcomes, both also offer a unique perspective on patient safety, contributing independently to the prediction of safety outcomes. These findings suggest that feedback from patients about the safety of the care that they receive can be used, in addition to data from staff to drive safety improvements in healthcare. TRIAL REGISTRATION NUMBER: ISRCTN07689702.

Emotion and coping in the aftermath of medical error: a cross-country exploration.

OBJECTIVES: Making a medical error can have serious implications for clinician well-being, affecting the quality and safety of patient care. Despite an advancing literature base, cross-country exploration of this experience is limited, and a paucity of studies has examined the coping strategies used by clinicians. A greater understanding of clinicians' responses to making an error, the factors that may influence these, and the various coping strategies used are all essential for providing effective clinician support and ensuring optimal outcomes.The objectives were therefore to investigate the following: a) the professional or personal disruption experienced after making an error, b) the emotional response and coping strategies used, c) the relationship between emotions and coping strategy selection, d) influential factors in clinicians' responses, and e) perceptions of organizational support. METHODS: A cross-sectional, cross-country survey of 265 physicians and nurses was undertaken in 2 large teaching hospitals in the United Kingdom and the United States. RESULTS: Professional and personal disruption was reported as a result of making an error. Negative emotions were common, but positive feelings of determination, attentiveness, and alertness were also identified. Emotional response and coping strategy selection did not differ because of location or perceived harm, but responses did appear to differ by professional group; nurses in both locations reported stronger negative feelings after an error. Respondents favored problem-focused coping strategies, and associations were identified between coping strategy selection and the presence of particular emotions. Organizational support services, particularly including peers, were recognized as helpful, but fears over confidentiality may prohibit some staff from accessing these. CONCLUSIONS: Clinicians in the United Kingdom and the United States experience professional and personal disruption after an error. A number of factors may influence clinician recovery; these factors should be considered in the provision of comprehensive support programs so as to improve clinician recovery and ensure higher quality, safer patient care.

Understanding diagnostic error: looking beyond diagnostic accuracy.

Whether a diagnosis is correct or incorrect is often used to determine diagnostic performance despite there being no valid measure of diagnostic accuracy. In this paper we draw on our experience of conducting research on diagnostic error and discuss some of the challenges that a focus on accuracy brings to this field of research. In particular, we discuss whether diagnostic accuracy can be captured and what diagnostic accuracy does and does not tell us about diagnostic judgement. We draw on these points to argue that a focus on diagnostic accuracy may limit progress in this field and suggest that research which tries to understand more about the factors that influence decision making during the diagnostic process may be more useful in helping to improve diagnostic performance.

Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial.

BACKGROUND: Estimates show that as many as one in 10 patients are harmed while receiving hospital care. Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour, with little involvement of patients. The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care. Over the past 3 years, our research team have developed, tested and refined the PRASE (Patient Reporting and Action for a Safe Environment) intervention, which gains patient feedback about quality and safety on hospital wards. METHODS/DESIGN: A multi-centre, cluster, wait list design, randomised controlled trial with an embedded qualitative process evaluation. The aim is to assess the efficacy of the PRASE intervention, in achieving patient safety improvements over a 12-month period.The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England. The PRASE intervention comprises two tools: (1) a 44-item questionnaire which asks patients about safety concerns and issues; and (2) a proforma for patients to report (a) any specific patient safety incidents they have been involved in or witnessed and (b) any positive experiences. These two tools then provide data which are fed back to wards in a structured feedback report. Using this report, ward staff are asked to hold action planning meetings (APMs) in order to action plan, then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience.The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results. METHODS: fieldworker diaries, ethnographic observation of APMs, structured interviews with APM lead and collection of key data about intervention wards. Intervention fidelity will be assessed primarily by adherence to the intervention via scoring based on an adapted framework. DISCUSSION: This study will be one of the largest patient safety trials ever conducted, involving 32 hospital wards. The results will further understanding about how patient feedback on the safety of care can be used to improve safety at a ward level. Incorporating the 'patient voice' is critical if patient feedback is to be situated as an integral part of patient safety improvements. TRIAL REGISTRATION: ISRCTN07689702, 16 Aug 2013.