The Measurement of Threats to Patient Safety in Australian General Practice

The importance of better understanding error and safety in the community setting is widely accepted, with recent calls to promote efforts and improve resources in this area of research (Jacobson, Elwyn et al. 2003). The measurement of patient safety events in primary care is a relatively under-researched area and it is well recognized that there are large gaps in the research describing patient safety in ambulatory settings (Hammons, Piland et al. 2003). Attitudes towards embracing safety event measurement have improved in recent years, however there remains a substantial amount of work to be done before common standards can be recommended, despite recent calls in the scientific literature for national and international systems (Runciman, Williamson et al. 2006). This thesis describes the Threats to Australian Patient Safety (TAPS) study, which aimed to create a secure anonymous web-based error reporting system suited to the Australian general practice setting, and then describe and quantify the errors reported by a representative random sample of Australian general practitioners. The study was made possible with the support of funding from a National Health and Medical Research Council project grant, and also gained support from NSW Health and the Commonwealth Department of Health and Aging in the form of granting qualified privilege and providing essential Medicare data under legal instrument. The study methodology involved the development of a database management system which created an electronic method for managing and analysing a wide variety of vii features related to large numbers of anonymously reported errors from Australian general practice. A representative random sample of 84 general practitioners (GPs) from New South Wales (NSW) participated in the study, with over 400 errors reported in a 12 month period. The key messages arising from the TAPS study were: • GPs embraced anonymous patient safety event reporting using a secure website, with the majority of study participants making reports • New findings from this study on the incidence of reported error in general practice were published in the scientific literature, which will help guide the design of future error reporting systems • A new taxonomy to describe reported error from GPs was developed as part of this study and published in the scientific literature, with the view of allowing future self-coding of reported patient safety events by GPs The TAPS study presented the first calculations known worldwide of the incidence of reported error in a general practice setting using a representative random sample of general practitioners. It was found that if an anonymous, secure, web-based reporting system was provided, approximately 2 errors were reported by general practitioners per 1000 patients seen per year (Makeham, Kidd et al. 2006). In addition, the study created a simple descriptive general practice based error taxonomy, entitled the TAPS taxonomy (see Appendix 10) (Makeham, Stromer et al. 2007), and was the first study to test the reproducibility of the application of such a viii tool using a group of general practitioners. The TAPS taxonomy developed as part of this study was found to have a good level of inter-coder agreement. With respect to the underlying causes of errors, the TAPS study found that the majority of reported patient safety events were errors related to the processes of health care (70%), rather than errors related to the knowledge and skills of health professionals (30%). Most errors reported in the TAPS study had the direct involvement of a patient (93% of error reports). Overall the reporting general practitioners were very familiar with these patients, who were on average 52 years old, and more often female (56%). Around one quarter of the errors reported was associated with patients being harmed. Reports containing events related to processes of health care were associated less with harm than those containing events related to the knowledge and skills of health professionals. The patients in errors associated with patient harm reported in the TAPS study were on average older than patients in reports where no harm was known to have occurred (58 years versus 50 years respectively). There was no statistically significant difference found between these groups with respect to gender or ethnicity, including people from Non-English speaking backgrounds or Aboriginal and Torres Strait Islander (ATSI) peoples, although the association with the latter group approached statistical significance. ix Cases of patient death were reported in 8 of 415 errors reported in the TAPS study (2%), and more often involved events relating to the knowledge and skills of health professionals than events relating to the processes of health care compared to reports not involving a known patient death. In support of suggestions in the scientific literature about the importance of anonymity as a feature of an error reporting system, a feedback interview found that an anonymous reporting system was a factor which made participants more likely to report error events, with two thirds of participants agreeing that anonymity made them more likely to participate in reporting. The majority of participants found the reporting process easy to undertake, and took approximately 6 minutes to send a report. The study provided a self directed learning educational activity for participating general practitioners that was approved for 30 group 1 Quality Assurance and Continuing Education points by the Royal Australian College of General Practitioners (RACGP). An important practical outcome of the TAPS study was that it highlighted a systematic error relating to immunisation failures with meningococcal vaccines which was reported to relevant organisations including NSW Health, the RACGP and the manufacturer involved, which was addressed with educational materials for GPs being distributed and communication in Australian Family Physician. x There are further analyses that could be undertaken using the TAPS data to improve our understanding of the errors reported, such as further statistical analyses using techniques such as building a model with multiple regression to determine significant factors that contribute to different error types. This work was beyond the scope of the TAPS study aims, but is part of further research recommendations. In addition, future studies should address aspects of patient safety and reported error that it would not be possible to capture from the perspective of the reporting GP. Rather than one taxonomy which describes the reported errors from the GP’s perspective in the way that the TAPS taxonomy does, it may be useful to develop a series of interlinked taxonomies that are directed to the needs of differing constituencies, such as the organisation providing health funds or the health insurer, the health regulators and legislators, and the patients or their significant others. The assessment of potential and actual harms sustained by patients involved in reported errors is a further area of patient safety research that is difficult to comprehensively assess, and existing reporting systems in the literature, whilst addressing this from the reporter’s perspective, require further work to improve the accuracy by which harm is measured and correlated with other data sets such as those managed by health insurers, and the experiences of people who are the subject of the reports. The TAPS study presents a number of new findings about the nature of error and threats to patient safety that arise in the Australian health care environment, reported by a representative sample of general practitioners, and it is hoped that these will be xi useful to all stakeholders in the health care setting, from clinicians, through to policy makers, and most importantly the patients who are the subject of the potentially preventable harms and near misses that are highlighted in this thesi

The Measurement of Threats to Patient Safety in Australian General Practice

The importance of better understanding error and safety in the community setting is widely accepted, with recent calls to promote efforts and improve resources in this area of research (Jacobson, Elwyn et al. 2003). The measurement of patient safety events in primary care is a relatively under-researched area and it is well recognized that there are large gaps in the research describing patient safety in ambulatory settings (Hammons, Piland et al. 2003). Attitudes towards embracing safety event measurement have improved in recent years, however there remains a substantial amount of work to be done before common standards can be recommended, despite recent calls in the scientific literature for national and international systems (Runciman, Williamson et al. 2006). This thesis describes the Threats to Australian Patient Safety (TAPS) study, which aimed to create a secure anonymous web-based error reporting system suited to the Australian general practice setting, and then describe and quantify the errors reported by a representative random sample of Australian general practitioners. The study was made possible with the support of funding from a National Health and Medical Research Council project grant, and also gained support from NSW Health and the Commonwealth Department of Health and Aging in the form of granting qualified privilege and providing essential Medicare data under legal instrument. The study methodology involved the development of a database management system which created an electronic method for managing and analysing a wide variety of vii features related to large numbers of anonymously reported errors from Australian general practice. A representative random sample of 84 general practitioners (GPs) from New South Wales (NSW) participated in the study, with over 400 errors reported in a 12 month period. The key messages arising from the TAPS study were: • GPs embraced anonymous patient safety event reporting using a secure website, with the majority of study participants making reports • New findings from this study on the incidence of reported error in general practice were published in the scientific literature, which will help guide the design of future error reporting systems • A new taxonomy to describe reported error from GPs was developed as part of this study and published in the scientific literature, with the view of allowing future self-coding of reported patient safety events by GPs The TAPS study presented the first calculations known worldwide of the incidence of reported error in a general practice setting using a representative random sample of general practitioners. It was found that if an anonymous, secure, web-based reporting system was provided, approximately 2 errors were reported by general practitioners per 1000 patients seen per year (Makeham, Kidd et al. 2006). In addition, the study created a simple descriptive general practice based error taxonomy, entitled the TAPS taxonomy (see Appendix 10) (Makeham, Stromer et al. 2007), and was the first study to test the reproducibility of the application of such a viii tool using a group of general practitioners. The TAPS taxonomy developed as part of this study was found to have a good level of inter-coder agreement. With respect to the underlying causes of errors, the TAPS study found that the majority of reported patient safety events were errors related to the processes of health care (70%), rather than errors related to the knowledge and skills of health professionals (30%). Most errors reported in the TAPS study had the direct involvement of a patient (93% of error reports). Overall the reporting general practitioners were very familiar with these patients, who were on average 52 years old, and more often female (56%). Around one quarter of the errors reported was associated with patients being harmed. Reports containing events related to processes of health care were associated less with harm than those containing events related to the knowledge and skills of health professionals. The patients in errors associated with patient harm reported in the TAPS study were on average older than patients in reports where no harm was known to have occurred (58 years versus 50 years respectively). There was no statistically significant difference found between these groups with respect to gender or ethnicity, including people from Non-English speaking backgrounds or Aboriginal and Torres Strait Islander (ATSI) peoples, although the association with the latter group approached statistical significance. ix Cases of patient death were reported in 8 of 415 errors reported in the TAPS study (2%), and more often involved events relating to the knowledge and skills of health professionals than events relating to the processes of health care compared to reports not involving a known patient death. In support of suggestions in the scientific literature about the importance of anonymity as a feature of an error reporting system, a feedback interview found that an anonymous reporting system was a factor which made participants more likely to report error events, with two thirds of participants agreeing that anonymity made them more likely to participate in reporting. The majority of participants found the reporting process easy to undertake, and took approximately 6 minutes to send a report. The study provided a self directed learning educational activity for participating general practitioners that was approved for 30 group 1 Quality Assurance and Continuing Education points by the Royal Australian College of General Practitioners (RACGP). An important practical outcome of the TAPS study was that it highlighted a systematic error relating to immunisation failures with meningococcal vaccines which was reported to relevant organisations including NSW Health, the RACGP and the manufacturer involved, which was addressed with educational materials for GPs being distributed and communication in Australian Family Physician. x There are further analyses that could be undertaken using the TAPS data to improve our understanding of the errors reported, such as further statistical analyses using techniques such as building a model with multiple regression to determine significant factors that contribute to different error types. This work was beyond the scope of the TAPS study aims, but is part of further research recommendations. In addition, future studies should address aspects of patient safety and reported error that it would not be possible to capture from the perspective of the reporting GP. Rather than one taxonomy which describes the reported errors from the GP’s perspective in the way that the TAPS taxonomy does, it may be useful to develop a series of interlinked taxonomies that are directed to the needs of differing constituencies, such as the organisation providing health funds or the health insurer, the health regulators and legislators, and the patients or their significant others. The assessment of potential and actual harms sustained by patients involved in reported errors is a further area of patient safety research that is difficult to comprehensively assess, and existing reporting systems in the literature, whilst addressing this from the reporter’s perspective, require further work to improve the accuracy by which harm is measured and correlated with other data sets such as those managed by health insurers, and the experiences of people who are the subject of the reports. The TAPS study presents a number of new findings about the nature of error and threats to patient safety that arise in the Australian health care environment, reported by a representative sample of general practitioners, and it is hoped that these will be xi useful to all stakeholders in the health care setting, from clinicians, through to policy makers, and most importantly the patients who are the subject of the potentially preventable harms and near misses that are highlighted in this thesi

Qualitative evaluation of a diabetes electronic decision support tool: views of users

BACKGROUND: Quality care of type 2 diabetes is complex and requires systematic use of clinical data to monitor care processes and outcomes. An electronic decision support (EDS) tool for the management of type 2 diabetes in primary care was developed by the Australian Pharmaceutical Alliance. The aim of this qualitative study was to evaluate the uptake and use of the EDS tool as well as to describe the impact of the EDS tool on the primary care consultation for diabetes from the perspectives of general practitioners and practice nurses. METHODS: This was a qualitative study of telephone interviews. General Practitioners and Practice Nurses from four Divisions of General Practice who had used the EDS tool for a minimum of six weeks were invited to participate. Semi-structured interviews were conducted and the interview transcripts were coded and thematically analysed using NVivo 8 software. RESULTS: In total 15 General Practitioners and 2 Practice Nurses completed the interviews. The most commonly used feature of the EDS tool was the summary side bar; its major function was to provide an overview of clinical information and a prompt or reminder to diabetes care. It also assisted communication and served an educational role as a visual aide in the consultation. Some participants thought the tool resulted in longer consultations. There were a range of barriers to use related to the design and functionality of the tool and to the primary care context. CONCLUSIONS: The EDS tool shows promise as a way of summarising information about patients’ diabetes state, reminder of required diabetes care and an aide to patient education

Lessons from the TAPS study - Message handling and appointment systems

The Threats to Australian Patient Safety (TAPS) Study collected 648 anonymous reports about threats to patient safety from a representative random sample of Australian general practitioners. These contained any events the GPs felt should not have happened, and would not want to happen again, regardless of who was at fault or the outcome of the event. This series of articles presents clinical lessons resulting from the TAPS study.2 page(s

Lessons from the TAPS study - Management of medical emergencies

The Threats to Australian Patient Safety (TAPS) study collected 648 anonymous reports about threats to patient safety by a representative random sample of Australian general practitioners. These contained any events the GPs felt should not have happened, and would not want to happen again, regardless of who was at fault or the outcome of the event. This series of articles presents clinical lessons resulting from the TAPS study.3 page(s

Lessons from the TAPS study - Errors relating to medical records

The Threats to Australian Patient Safety (TAPS) Study collected 648 anonymous reports about threats to patient safety from a representative random sample of Australian general practitioners. These contained any events the GPs felt should not have happened and would not want to happen again, regardless of who was at fault or the outcome of the event. This series of articles presents clinical lessons resulting from the TAPS study.2 page(s

Lessons from the TAPS study - Managing investigation results - is your practice system safe?

The TAPS study found that errors in the process of providing health care were reported by general practitioners more than twice as often as deficiencies in a clinician's knowledge or skills. Approximately 20% of these process error events concerned investigations. In addition, some reported events that related to investigations included filing system and recall errors, which accounted for a further 10% of reported error events.2 page(s

Sources of unsafe primary care for older adults: a mixed-methods analysis of patient safety incident reports

Background: Older adults are frequent users of primary healthcare services, but are at increased risk of healthcare-related harm in this setting. Objectives: To describe the factors associated with actual or potential harm to patients aged 65 years and older, treated in primary care, to identify action to produce safer care. Design and Setting: A cross-sectional mixed-methods analysis of a national (England and Wales) database of patient safety incident reports from 2005 to 2013. Subjects: 1,591 primary care patient safety incident reports regarding patients aged 65 years and older. Methods: We developed a classification system for the analysis of patient safety incident reports to describe: the incident and preceding chain of incidents; other contributory factors; and patient harm outcome. We combined findings from exploratory descriptive and thematic analyses to identify key sources of unsafe care. Results: The main sources of unsafe care in our weighted sample were due to: medication-related incidents e.g. prescribing, dispensing and administering (n = 486, 31%; 15% serious patient harm); communication-related incidents e.g. incomplete or non-transfer of information across care boundaries (n = 390, 25%; 12% serious patient harm); and clinical decision-making incidents which led to the most serious patient harm outcomes (n = 203, 13%; 41% serious patient harm). Conclusion: Priority areas for further research to determine the burden and preventability of unsafe primary care for older adults, include: the timely electronic tools for prescribing, dispensing and administering medication in the community; electronic transfer of information between healthcare settings; and, better clinical decision-making support and guidance