Pressure injuries are problematic to health systems throughout the world, significantly harming over 7 million patients and adding extraordinary costs. The USA, for instance, experiences more than 2.5 million pressure injury cases per year which cause over 60 000 deaths—that is more than car accident fatalities in the USA—and cost the health system at least $9–$11 billion.1 The UK is no less affected by 700 000 cases per year that result in 27 000 deaths and cost the National Health Service (NHS) an estimated £1.4–£2.1 billion.2
Despite there being no reason to expect major differences in the presentation of pressure injuries between the two countries, the UK appears mainly to have a problem with chronic pressure ulcers, whereas the USA appears to have an increasing burden of acute pressure ulcers.3 4 The UK NHS reports chronic wounds accounting for 78% of the NHS spending on wound treatments.
Assuring public safety after widespread adoption of medical devices is critically important, and has been identified as a priority by the Food and Drug Administration (FDA).1 Growing public concern regarding postmarket safety of medical devices stems in part from an increasing recognition that medical device failure, although infrequent, may lead to injury. Regulatory agencies, such as FDA, are faced with the competing pressures of ensuring patient safety while simultaneously improving the efficiency of medical device approval. Unfortunately, premarket medical device approval studies are frequently limited by small sample size, restricted patient and provider populations, and inadequate duration of follow-up.2 3 Therefore, strengthening approaches of postmarket safety evaluation are increasingly important.
The FDA strategy for postmarket safety evaluation has relied extensively on reporting of adverse events by physicians, patients and device manufacturers through the Medical Device Reporting system. It has become increasingly apparent that, despite...
Internationally, primary care is under pressure. In 10 developed nations surveyed for the 2015 Commonwealth report, primary care physicians reported their struggle to find ways to care for ageing populations with complex healthcare needs.1 Practice consultation rates, average consultation duration and total patient-facing clinical workload have increased substantially in primary care in recent years.2 Increases in demand have not been matched by growth in either funding or in workforce: in the UK alone, the shortage of general practitioners (GPs) is expected to worsen from 3300 in 2015 to 8000 by 2020. Over and above rising demand, factors such as advances in technology, the shifting workload from secondary to primary care, and patients’ growing health and social care needs (including more complicated drug regimens and challenging national clinical standards) have all added to complexity.3
Much discussion has focused on how to increase the supply...
Contemporary health policies frequently invoke notions of ‘culture’ and ‘cultural change’ as levers for achieving performance improvement and good-quality healthcare.1 But it has remained unclear whether talk of culture is largely empty rhetoric or whether framing healthcare organisations in ‘cultural’ terms offers useful insights that might improve organisational processes and outcomes of care. When considering the role of organisational culture in facilitating high-quality care and improved outcomes, a first important step is to explain what is meant by organisational culture, and then consider the evidence that organisational culture can be purposively managed and form part of efforts to improve quality and clinical performance in healthcare delivery organisations.
A recent systematic review found a consistent association between positive organisational and workplace cultures and beneficial clinical outcomes, including reduced mortality rates across a variety of health settings.2 Most ‘included’ studies in the review consisted of observational and...
Hospital-acquired pressure injuries (HAPIs) are publicly reported in the USA and used to adjust Medicare payment to acute inpatient facilities. Current methods used to identify HAPIs in administrative claims rely on hospital-reported present-on-admission (POA) data instead of prior patient health information.Objective
To study the reliability of claims data for HAPIs and pressure injury (PI) stage by evaluating diagnostic coding agreement across interfacility transfers.Methods
Using the 2012 100% Medicare Provider and Analysis Review file, we identified all fee-for-service acute inpatient discharge records with a PI diagnosis among Medicare patients 65 years and older. We then identified additional facility claims (eg, acute inpatient, long-stay inpatient or skilled nursing facility) belonging to the same patient who had either (1) admission within 1day of hospital discharge or (2) discharge within 1day of hospital admission. Multivariable logistic regression and stratified kappa statistics were used to measure coding agreement between transferring and receiving facilities in the presence or absence of a PI diagnosis at the time of patient transfer and PI stage category (early vs advanced).Results
In our comparison of claims data between transferring and receiving facilities, we observed poor agreement in the presence or absence of a PI diagnosis at the time of transfer (36.3%, kappa=0.03) and poor agreement in PI stage category (74.3%, kappa=0.17). Among transfers with a POA PI reported by the receiving hospital, only 34.0% had a PI documented at the prior transferring facility.Conclusions
The observed discordance in PI documentation and staging between transferring and receiving facilities may indicate inaccuracy of HAPI identification in claims data. Future research should evaluate the accuracy of hospital-reported POA data and its impact on PI quality measurement.
Postmarket surveillance of medical devices is reliant on physician reporting of adverse medical device events (AMDEs). Little is known about factors that influence whether and how physicians report AMDEs, an essential step in developing behaviour change interventions. This study explored factors that influence AMDE reporting.Methods
Qualitative interviews were conducted with physicians who differed by specialties that implant cardiovascular and orthopaedic devices prone to AMDEs, geography and years in practice. Participants were asked if and how they reported AMDEs, and the influencing factors. Themes were identified inductively using constant comparative technique, and reviewed and discussed by the research team on four occasions.Results
Twenty-two physicians of varying specialty, region, organisation and career stage perceived AMDE reporting as unnecessary, not possible or futile due to multiple factors. Physicians viewed AMDEs as an expected part of practice that they could manage by switching to different devices or developing work-around strategies for problematic devices. Physician beliefs and behaviour were reinforced by limited healthcare system capacity and industry responsiveness. The healthcare system lacked processes and infrastructure to detect, capture, share and act on information about AMDEs, and constrained device choice through purchasing contracts. The device industry did not respond to reports of AMDEs from physicians or improve their products based on such reports. As a result, participants said they used devices that were less than ideal for a given patient, leading to suboptimal patient outcomes.Conclusions
There may be little point in solely educating or incentivising individual physicians to report AMDEs unless environmental conditions are conducive to doing so. Future research should explore policies that govern AMDEs and investigate how to design and implement postmarket surveillance systems.
Prescribing is a high-volume primary care routine where both speed and attention to detail are required. One approach to examining how organisations approach quality and safety in the face of high workloads is Hollnagel’s Efficiency and Thoroughness Trade-Off (ETTO). Hollnagel argues that safety is aligned with thoroughness and that a choice is required between efficiency and thoroughness as it is not usually possible to maximise both. This study aimed to ethnographically examine the efficiency and thoroughness trade-offs made by different UK general practices in the achievement of prescribing safety.Methods
Non-participant observation was conducted of prescribing routines across eight purposively sampled UK general practices. Sixty-two semistructured interviews were also conducted with key practice staff alongside the analysis of relevant practice documents.Results
The eight practices in this study adopted different context-specific approaches to safely handling prescription requests by variably prioritising speed of processing by receptionists (efficiency) or general practitioner (GP) clinical judgement (thoroughness). While it was not possible to maximise both at the same time, practices situated themselves at various points on an efficiency-thoroughness spectrum where one approach was prioritised at particular stages of the routine. Both approaches carried strengths and risks, with thoroughness-focused approaches considered safer but more challenging to implement in practice due to GP workload issues. Most practices adopting efficiency-focused approaches did so out of necessity as a result of their high workload due to their patient population (eg, older, socioeconomically deprived).Conclusions
Hollnagel’s ETTO presents a useful way for healthcare organisations to optimise their own high-volume processes through reflection on where they currently prioritise efficiency and thoroughness, the stages that are particularly risky and improved ways of balancing competing priorities.
Hospital organisational culture affects patient outcomes including mortality rates for patients with acute myocardial infarction; however, little is known about whether and how culture can be positively influenced.Methods
This is a 2-year, mixed-methods interventional study in 10 US hospitals to foster improvements in five domains of organisational culture: (1) learning environment, (2) senior management support, (3) psychological safety, (4) commitment to the organisation and (5) time for improvement. Outcomes were change in culture, uptake of five strategies associated with lower risk-standardised mortality rates (RSMR) and RSMR. Measures included a validated survey at baseline and at 12 and 24 months (n=223; average response rate 88%); in-depth interviews (n=393 interviews with 197 staff); and RSMR data from the Centers for Medicare and Medicaid Services.Results
We observed significant changes (p<0.05) in culture between baseline and 24 months in the full sample, particularly in learning environment (p<0.001) and senior management support (p<0.001). Qualitative data indicated substantial shifts in these domains as well as psychological safety. Six of the 10 hospitals achieved substantial improvements in culture, and four made less progress. The use of evidence-based strategies also increased significantly (per hospital average of 2.4 strategies at baseline to 3.9 strategies at 24 months; p<0.05). The six hospitals that demonstrated substantial shifts in culture also experienced significantly greater reductions in RSMR than the four hospitals that did not shift culture (reduced RSMR by 1.07 percentage points vs 0.23 percentage points; p=0.03) between 2011–2014 and 2012–2015.Conclusions
Investing in strategies to foster an organisational culture that supports high performance may help hospitals in their efforts to improve clinical outcomes.
Quality collaboratives are widely endorsed as a potentially effective method for translating and spreading best practices for acute myocardial infarction (AMI) care. Nevertheless, hospital success in improving performance through participation in collaboratives varies markedly. We sought to understand what distinguished hospitals that succeeded in shifting culture and reducing 30-day risk-standardised mortality rate (RSMR) after AMI through their participation in the Leadership Saves Lives (LSL) collaborative.Procedures
We conducted a longitudinal, mixed methods intervention study of 10 hospitals over a 2-year period; data included surveys of 223 individuals (response rates 83%–94% depending on wave) and 393 in-depth interviews with clinical and management staff most engaged with the LSL intervention in the 10 hospitals. We measured change in culture and RSMR, and key aspects of working related to team membership, turnover, level of participation and approaches to conflict management.Main findings
The six hospitals that experienced substantial culture change and greater reductions in RSMR demonstrated distinctions in: (1) effective inclusion of staff from different disciplines and levels in the organisational hierarchy in the team guiding improvement efforts (referred to as the ‘guiding coalition’ in each hospital); (2) authentic participation in the work of the guiding coalition; and (3) distinct patterns of managing conflict. Guiding coalition size and turnover were not associated with success (p values>0.05). In the six hospitals that experienced substantial positive culture change, staff indicated that the LSL learnings were already being applied to other improvement efforts.Principal conclusions
Hospitals that were most successful in a national quality collaborative to shift hospital culture and reduce RSMR showed distinct patterns in membership diversity, authentic participation and capacity for conflict management.
Quality improvement collaboratives (QIC) have proliferated internationally, but there is little empirical evidence for their effectiveness.Method
We searched Medline, Embase, CINAHL, PsycINFO and the Cochrane Library databases from January 1995 to December 2014. Studies were included if they met the criteria for a QIC intervention and the Cochrane Effective Practice and Organisation of Care (EPOC) minimum study design characteristics for inclusion in a review. We assessed study bias using the EPOC checklist and the quality of the reported intervention using a subset of SQUIRE 1.0 standards.Results
Of the 220 studies meeting QIC criteria, 64 met EPOC study design standards for inclusion. There were 10 cluster randomised controlled trials, 24 controlled before-after studies and 30 interrupted time series studies. QICs encompassed a broad range of clinical settings, topics and populations ranging from neonates to the elderly. Few reports fully described QIC implementation and methods, intensity of activities, degree of site engagement and important contextual factors. By care setting, an improvement was reported for one or more of the study’s primary effect measures in 83% of the studies (32/39 (82%) hospital based, 17/20 (85%) ambulatory care, 3/4 nursing home and a sole ambulance QIC). Eight studies described persistence of the intervention effect 6 months to 2 years after the end of the collaborative. Collaboratives reporting success generally addressed relatively straightforward aspects of care, had a strong evidence base and noted a clear evidence-practice gap in an accepted clinical pathway or guideline.Conclusions
QICs have been adopted widely as an approach to shared learning and improvement in healthcare. Overall, the QICs included in this review reported significant improvements in targeted clinical processes and patient outcomes. These reports are encouraging, but most be interpreted cautiously since fewer than a third met established quality and reporting criteria, and publication bias is likely.
Methods to identify preventable adverse events typically have low yield and efficiency. We refined the methods of Institute of Healthcare Improvement’s Global Trigger Tool (GTT) application and leveraged electronic health record (EHR) data to improve detection of preventable adverse events, including diagnostic errors.Methods
We queried the EHR data repository of a large health system to identify an ‘index hospitalization’ associated with care escalation (defined as transfer to the intensive care unit (ICU) or initiation of rapid response team (RRT) within 15 days of admission) between March 2010 and August 2015. To enrich the record review sample with unexpected events, we used EHR clinical data to modify the GTT algorithm and limited eligible patients to those at lower risk for care escalation based on younger age and presence of minimal comorbid conditions. We modified the GTT review methodology; two physicians independently reviewed eligible ‘e-trigger’ positive records to identify preventable diagnostic and care management events.Results
Of 88 428 hospitalisations, 887 were associated with care escalation (712 ICU transfers and 175 RRTs), of which 92 were flagged as trigger-positive and reviewed. Preventable adverse events were detected in 41 cases, yielding a trigger positive predictive value of 44.6% (reviewer agreement 79.35%; Cohen’s kappa 0.573). We identified 7 (7.6%) diagnostic errors and 34 (37.0%) care management-related events: 24 (26.1%) adverse drug events, 4 (4.3%) patient falls, 4 (4.3%) procedure-related complications and 2 (2.2%) hospital-associated infections. In most events (73.1%), there was potential for temporary harm.Conclusion
We developed an approach using an EHR data-based trigger and modified review process to efficiently identify hospitalised patients with preventable adverse events, including diagnostic errors. Such e-triggers can help overcome limitations of currently available methods to detect preventable harm in hospitalised patients.
Healthcare providers and payers continue to consolidate into larger firms. One type of consolidation, known as vertical integration, occurs when hospitals or health systems offer their own insurance products.1 Proponents argue that consolidation improves efficiency, but there is little evidence on the relationship between provider-offered health insurance and quality of care.2 Therefore, we compared the quality of provider-offered Medicare Advantage (MA) to that of insurer-offered contracts.Methods
Using publicly available MA contract and enrolment files from the Centers for Medicare & Medicaid Services (CMS), we constructed a data set identifying all provider-offered contracts from 2011 to 2015 (n=2030 contract years). For the purposes of this study, provider-offered means that the parent organisation of the MA contract and provider organisation are or are owned by the same firm. To make this determination, we followed the approach of Frakt et al and Johnson et al.