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Abstract
Background Patients can have an important role in reducing harm in primary-care settings. Learning from patient experience and feedback could improve patient safety. Evidence that captures patients’ views of the various contributory factors to creating safe primary care is largely absent. The aim of this study was to address this evidence gap.
Methods Four focus groups and eight semistructured interviews were conducted with 34 patients and carers from south-east Australia. Participants were asked to describe their experiences of primary care. Audio recordings were transcribed verbatim and specific factors that contribute to safety incidents were identified in the analysis using the Yorkshire Contributory Factors Framework (YCFF). Other factors emerging from the data were also ascertained and added to the analytical framework.
Results Thirteen factors that contribute to safety incidents in primary care were ascertained. Five unique factors for the primary-care setting were discovered in conjunction with eight factors present in the YCFF from hospital settings. The five unique primary care contributing factors to safety incidents represented a range of levels within the primary-care system from local working conditions to the upstream organisational level and the external policy context. The 13 factors included communication, access, patient factors, external policy context, dignity and respect, primary–secondary interface, continuity of care, task performance, task characteristics, time in the consultation, safety culture, team factors and the physical environment.
Discussion Patient and carer feedback of this type could help primary-care professionals better understand and identify potential safety concerns and make appropriate service improvements. The comprehensive range of factors identified provides the groundwork for developing tools that systematically capture the multiple contributory factors to patient safety.
- Patient safety
- Primary care
- Qualitative research
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Introduction
Primary care is the first point of contact for most people entering the health system, and most patient journeys begin and end in primary care. While the level of harm is relatively low compared with secondary care, diagnostic or prescribing errors are predicted to occur in 1 in every 20 patients.1 ,2
Given these predicted rates of error, it is crucial to find ways for patients to be involved in improving safety. Evidence has emerged suggesting patients and carers are willing and able to provide feedback on the safety of healthcare.3 ,4 Patients are uniquely placed to observe their care, treatment and physical environment throughout their journey in the health system. Patients’ views and understandings of safety can also help to identify issues that staff or others may not recognise.5
Most of the research described above has been conducted in secondary-care settings. Furthermore, patient feedback about healthcare has mainly used complaint systems and patient satisfaction surveys of which the latter has been criticised for positive-reporting biases, lacking clarity of aims, non-standardisation and unreliability.6 ,7 In more recent times, patient feedback websites have been developed, such as NHS Choices, ‘iWantGreatCare’ and Patient Opinion (Patient Opinion available in the UK and Australia). While these websites are beneficial for patients, they often contain little information about safety, are secondary-care focused and the quality of data is poor.8 ,9
Little evidence exists in the primary-care setting about patients’ views of safety. There is some literature that reports patient identified issues regarding their care,10–13 but these studies have focused on patient concerns from a quality rather than safety perspective. One study undertaken by our research group indicated that patients have an assumed sense of safety, which was mediated by the trusting and the continual nature of the doctor–patient relationship. These factors impacted on patients’ and carers’ perceptions of overall risk in this setting.14 We hypothesise that, regardless of an assumed sense of safety, patients and carers may still be able to identify environmental or organisational factors, which contribute to patient safety incidents in primary care. This has been shown to be the case in UK hospital settings where patients have been able to identify a range of factors that contribute to safety incidents.4
A greater understanding of the factors that contribute to creating safe healthcare environments is important for everyone, including patients, staff and policy makers to help prevent harm from occurring. This approach corresponds with a ‘system view’ of healthcare, which aims to ‘seek out and remove the error provoking properties (latent and error producing conditions) within healthcare systems’.15 The latent conditions or blunt end factors are the organisational structure, management systems, workplace culture and the policies and procedures that affect how care is delivered. The error-producing conditions or sharp end factors directly relate to the work environment and human performance more proximate to the error such as team (eg, supervision, leadership, interprofessional communication), task (eg, use of protocols and guidelines) and individual factors (eg, knowledge, skill, experience and attitude) and patient characteristics (eg, complexity of health conditions, personality and communication ability).15 ,16
In the absence of in-depth evidence about this research area, the aim of our study was to analyse data describing patients’ and carers’ experiences of Australian general practice to identify the factors that contribute to patient safety incidents in primary care. The contributory factors to safety incidents were defined as any patient and carer-reported latent or error-producing condition, which resulted in real or perceived harm that could have been prevented or avoided. The intention was to undertake a broad descriptive study of possible contributing factors to patient safety incidents in primary care so that more detailed studies could follow that fully explored this phenomenon in greater depth.
The Yorkshire Contributory Factors Framework (YCFF)17 provided the framework for analysis (see online supplementary file 1). There are various models to conceptualise potential latent conditions that influence safety in healthcare systems, including Reason's accident causation model,15 the London protocol18 and Systems Engineering Initiative for Patient Safety (SEIPS).19 The YCFF was selected as the authors considered this taxonomy of contributing factors to patient safety incidents to be both comprehensive and specific enough to address the aims of this study. Furthermore, the YCFF was theoretically originated from Reason's accident causation model of organisational safety that has been applied to various healthcare settings and contexts, including primary care.15 The YCFF succinctly describes both the latent organisational failures and the error-producing conditions in which active failures occur, and is based on a systematic review of empirical evidence.
Methods
Rural and regional patients and carers from several communities of south-east Australia who were potentially frequent users of general practice were recruited into the study.
Rural and regional areas were classified according to the Australian Standard Geographical Classification Remoteness Index categories.20 The communities in these rural and regional areas are diverse with some areas having a wide range of primary, secondary, allied and community health services, and others having limited access to any type of health service. The populations in the communities range from approximately 300 to 10 000 people.
Frequent users were considered as those with a chronic condition (ie, diabetes, cardiovascular disease, arthritis), on repeat medication, older people and mothers with children. These participants were likely to have more experience of general practice, and therefore to have greater insight into specific safety issues.
Study participants were recruited from education and support group meetings conducted at local primary care organisations such as type 2 diabetes self-management, cardiac rehabilitation, group exercise and a mothers’ group. Participants who were interested in the study first opted to take part in a focus group. Participants who could not attend a focus group were then asked to take part in a semistructured interview.
Four focus groups and eight semistructured interviews were conducted by ALH with patients and carers. Focus groups lasted approximately 90 min, and the semistructured interviews ranged between 20 and 60 min in duration. Different participants took part in focus groups and interviews.
The focus groups were relatively homogenous in terms of patient characteristics, where possible. Naturally occurring groups such as mothers’ groups and exercise groups took part in focus groups when appropriate. Other focus groups consisted mainly of patients and carers with various chronic disease profiles, and were of similar ages.
Focus groups were initially used to obtain a broad understanding of participants’ experiences, as previous research demonstrated that many patients were not familiar with direct terms like ‘patient safety’, and this appeared to discourage participants from engaging in the research.4 Focus groups were conducted until theme saturation was complete, and the subsequent semistructured interviews were used to elicit a detailed and rich description of patients’ experiences and to further pursue particular safety points of interest that surfaced in the focus groups and to confirm or contest these issues. This approach was used to support and sharpen the thematic summary obtained originally in focus groups.21 ,22
Accordingly, the interview protocol was broad in nature and designed to focus on patient experience. Questions focused on describing normal visits, relationships with primary-care staff, values placed on care and patient involvement. These questions were further refined during data collection with addition of follow-up questions capturing patient identified factors contributing to safety incidents. The facilitator queried when participants disclosed particular harms they experienced. Questions included: what do you do when things go wrong? If you could improve something about the care you receive, what would it be? How do you think patients could be more involved or active in their care in the future?
All focus groups and semistructured interviews were audio recorded and transcribed verbatim.
The YCFF was used as a starting point for analysis and open inquiry, apart from the active failures that appear at the centre of the framework.17 Data relating to participants’ disclosure of particular errors or mistakes were not analysed. Only the data relating to factors influencing the particular safety incident were analysed. Other factors not represented in the YCFF and specifically related to safety in primary care were also captured in the patients’ and carers’ accounts. These were inductively generated from the data using in vivo and self-derived codes. The final coding structure was discussed among the research team until agreement was reached. These codes were then applied to the entire dataset. When several factors appeared in single quotes or patient stories, multiple factors were coded to these single quotes. Analysis was independently performed by two researchers (ALH and SJG). Discrepancies between researchers were resolved through discussion and constant comparison with the data. NVivo 10 (QSR International) was used to support the analysis.
The factors resulting from the analysis were compared with a study on patient identified contributing factors to safety incidents in hospital settings,4 which also used the YCFF framework.17
Flinders University Social and Behavioural Research Ethics Committee approved the study (project no. 5667). Participants provided informed written consent and received a AUD50 shopping voucher for their time and travel expenses.
Results
Forty-six individuals consented to participate, of which 26 participated in four focus groups and eight semistructured interviews (table 1). Reasons for not participating from those who had provided consent included illness, conflicting engagements, loss of interest and failing to attend.
Participant demographic characteristics (n=34)
Thirteen patient and carer generated contributing factors to safety incidents were ascertained from the data. These are described in detail below. Eight factors were similar to the YCFF, and five were inductively generated from these data. In accordance with the YCFF, the external policy context, primary–secondary interface and the physical environment were considered to be the latent conditions, and access, patient factors, dignity and respect, continuity of care, task performance, task characteristics, time in the consultation and team factors were considered to be error-producing conditions. Communication and safety culture were considered to be cross-cutting factors that were a feature of both the latent and error-producing domains.
We have also compared these findings with a study on patient identified contributing factors to safety incidents in hospital settings, which also used the YCFF4 (table 2).
Thirteen primary care contributing factors to patient safety incidents and their relation to the YCFF and patient identified contributing factors to safety from a hospital setting
There are 19 contributing factors to safety incidents in the YCFF. The factors in the YCFF, not identified in this study, included equipment and supplies, design of equipment and supplies, individual factors, lines of responsibility, management of staff and staffing levels, policy and procedures, scheduling and bed management, staff workload, supervision and leadership, support from central functions and training and education.
Table 3 outlines the potential harm associated with the contributing factors and an illustrative quote from the participants. The factors were listed in descending order from most frequently mentioned to least frequently mentioned.
Patient identified factors contributing to patient safety incidents in primary care
Communication
Listening to patients’ concerns were considered to be highly important and that active listening assisted with appropriate and personalised treatment and care, increased accuracy of diagnosis, facilitated trust and reduced stress and anxiety. Instances of communication breakdown occasioned a range of patient actual harms, including misdiagnosis, delays in diagnosis and treatment, physical harm (pain and suffering) and psychological harms, including loss of trust, stress and anxiety, and feelings of vulnerability and intimidation.
Access
Timely access to primary care was important for preventing delays in diagnosis and treatment. Patients and carers unable to get an appointment with a doctor at a preferred time described the frustration, stress and anxiety resulting from not knowing where to get help and the potential worsening of their health condition. In some cases, inability to access care led to actual physical harms such as exacerbated pain and suffering and unintended health outcomes such as permanent disability (paralysis).
Participants also considered limited availability, distance from care and choice of doctors as subthemes contained within the access contributory factor to safety.
Patient factors
Participants who took direct actions to intervene and prevent potential harm from occurring considered themselves to be actively involved in managing their own safety. Ability to identify particularly harmful situations or possessing the knowledge and understanding of the contributing factor to safety incidents were attributed to many patient characteristics. These were variable and included but not limited to the patient or carer's personality, their past experiences with healthcare, their health status or the healthcare context. Actions to prevent potential harm included speaking up when dissatisfied, requesting second opinions, navigating access to care, taking responsibility for health and being informed about the risks and benefits of treatment and care. Fear about taking certain actions and potential vulnerability following these actions were perceived as barriers that prevented patient agency from occurring.
External policy context
Patients were conscious of the regulatory environment in which primary care operates. Empathy was expressed when general practitioners were perceived to be constrained by short consultation times as incentivised by Medicare.i The main Medicare issue they identified concerned the inequities and inconsistencies for bulk billing. While concessions were available for pensioners and low income families, there were instances where payment was left to the discretion of the GP. Access to bulk-billing GPs was difficult to obtain. Delays in diagnosis and treatment were a common consequence of not being able to afford medical care. Ongoing costs of essential medications not fully covered by the Pharmaceutical Benefits Schemeii created further delays in access to primary care.
Dignity and respect
Participants spoke about feeling valued by primary-care staff. In the few instances where there was non-personalised or unapproachable care, this then resulted in patients and carers feeling like a number or ‘cattle being herded’ within the larger system. In some ways, these experiences threatened patients’ personal identity.23 This reduced effective communication, and resulted in disrespect towards patients and carers. In some cases, patients’ and carers’ reported inappropriate behaviour where doctors subjected them to verbal abuse and belittlement. Rude or disrespectful treatment from other practice staff was less frequent, but resulted in actual psychological harms for those who were belittled or upset by the reception staff. Subsequently, patients avoided the practice.
Primary–secondary interface
Transitions between primary and secondary care were perceived as an area where communication and information sharing was problematic. Patients and carers were often responsible for managing this transition and coordinating information between healthcare providers. Participants considered that some patients may not be able to undertake this role. Providing accurate information about specific medical procedures might be burdensome for patients with a disability, those who are ill or had memory problems. Incorrect or delayed information relayed between primary or secondary care obstructed treatment and diagnosis, resulting in inappropriate or wrong treatment and further pain and suffering.
Continuity of care
Continuity of care was equivocal as it was described as both a potential safeguard against harm and as a potential contributing factor to a safety incident. A continuous relationship with a GP facilitated trust and confidence in providers. Prior knowledge of the patient was mentioned as something that influenced accurate diagnosis and treatment. When these relationships were compromised, patients were fearful of having to start over with a new doctor and the safety implications.
Discontinuity is often thought of as an undesirable characteristic in primary care,24 potentially contributing to unsafe care, but some discontinuity of care may also be an asset. Participants described receiving a second opinion from a different doctor who correctly diagnosed an ongoing health problem and prescribed effective treatment. Furthermore, prior knowledge of the patient (continuity of care) might increase the chances of diagnostic overshadowing. Some believed they were stereotyped by their disease status, and consequently, other diagnostic options and care were not investigated.
Task performance
Certain patients and carers noted awareness of providers who did not have the skill or competence to carry out particular tasks. Awareness was heightened for patients with previous experience of actual harm. Task performance was also recognised retrospectively when discussing particular safety incidents, when other health professionals highlighted errors or when other health professionals accurately performed the task. Loss of trust and confidence and being hesitant to seek care in the future were outcomes for patients whose safety had been compromised.
Diagnostic skill and failure to appreciate severity/acuity of the problem were the main tasks participants were able to comment on. Patients and carers noticed it when doctors and nurses were interested in or fixated on problems that were not considered most urgent by the patient or carer or not the primary reason for the visit.
Task characteristics
Care coordination and information management
Patients viewed the GP as being at the centre of healthcare encounters. Harm often resulted from misinformation or communication breakdown between the GP and the other healthcare providers, or when patient information was not centralised with one GP. Patient test results were delayed or poorly managed in some instances.
Participants got referrals to specialist services when requested. But some questioned whether GPs had a broad knowledge of all available referring services, which providers offered reduced or no out-of-pocket expenses and the timing of the referral in critical circumstances. Some considered GPs hesitant to refer patients, but the reason for this was unknown.
Prescribing
Medication interactions, wrong dosage and inappropriate prescribing were problems that participants discussed. Incorrect or interacting medications were identified by the pharmacist in most cases along with the patient.
Some patients encountered difficulties when attempting to resolve medication problems with their doctors. Actual prescribing error harms were generally pain and suffering, although none were considered by participants to be serious harms. Usually, patients intervened before serious medication harms occurred, for example, by seeking a second opinion or discontinuing use.
Decision making
Opportunities to be involved in decisions about care and treatment were desired by participants. Knowledge of the risks and benefits, and making appropriate decisions were important to these patients to ensure care was tailored to their needs and was safe. Engaging with them to make decisions, in their view, prevented unnecessary, unwanted or invasive treatment. Sharing in decisions gave these patients a sense of trust with their healthcare providers and reduced feelings of stress or anxiety.
Time in the consultation
All participants appreciated and valued having enough time in the consultation to communicate all their concerns. Adequate time reduced unnecessary subsequent visits, out-of-pocket expenses and further delays in care. Sufficient consultation time also facilitated patient and carer engagement, and their sense that the GP understood them and had knowledge of their needs and personal context. Moreover, patients and carers recognised that having enough time allowed for accurate diagnosis and treatment, improved patient satisfaction and generation and sustainment of the doctor–patient relationship.
Safety culture
Patients were aware of the culture and hierarchies evident within the organisation and its influence on care delivery. Patients identified practice leaders and how other staff interacted with them based on their role and responsibilities. Intimidation and restriction of staff to speak up about safety concerns to prevent actual patient harm were examples of poor organisational culture.
Team factors
Working collaboratively was seen to occur in two domains. First, patients aspired to be in a team with their doctor or nurse, which also extended to specialists and secondary-care providers. This sense of teamwork enabled patient involvement in care and increased satisfaction with the doctor–patient relationship. Second, teamwork between the GP and practice nurse was viewed as useful for recognising things the other person may not have identified, and facilitated transparency of information sharing and coordination of care.
Physical environment
Participants were satisfied with the physical layout of the practice. Infection control was mentioned by a few patients who were concerned about risks to health in the waiting-room from other patients who were contagious with cold and flu symptoms.
Discussion
The results from this study reveal that patients and carers were able to identify various latent failures and error-producing conditions in the primary-care environment that influence patient safety, and how those factors could contribute to creating patient safety incidents. This finding extends previous research that found patients and carers had an assumed sense of safety in general practice, as only those who had experienced some level of harm were able to adequately comment on safety.14 These findings show that, regardless of patients’ and carers’ experiences and awareness of safety, they have considerable understanding of, and ability to comment on the elements of primary care that impact on patient safety.
The utility of the YCFF when tested in an Australian primary-care context proved useful to develop an evidence base in the absence of other available models and literature. Other frameworks such as Reason's accident causation model15 or the London protocol18 may be suitable for the primary-care setting like the YCFF, but further research is needed to confirm their applicability. There were commonalities between secondary and primary care contributing factors to safety incidents contained in the YCFF. These were centred on things that are present in all health systems, such as team work, communication, the physical environment and patient factors. Contributory factors in the YCFF not commented on by patients were the design of equipment and supplies, scheduling and bed management, lines of responsibility, management of staff and staffing levels, staff workload and support from central functions. Some of these factors, such as bed management and support from central functions, are not relevant to the primary-care setting, and were not expected to emerge from the patient accounts. The remaining factors are possible contributing factors to safety for primary care, but were not mentioned by participants in this study. Further work is needed to understand patients’ and carers’ views of these factors.
The five unique primary care contributing factors to safety incidents represented both the latent conditions and direct error-producing conditions. This finding contrasts with what has been found for hospital patients’ views of contributing factors to safety incidents, which are more centred towards factors that patients could explicitly observe on the ward, or the sharp end of care.4 The continuity of care that characterises primary care makes it amenable to greater frequency of visits and hence greater chances of developing knowledge and understanding of the latent or blunt end factors that impact on care. Patient and carers being able to understand, recognise and provide feedback about these more latent factors may be useful for primary-care staff and policy makers, and can help to develop a ‘systems approach’ to practice improvement.
The range of contributing factors identified by patients and carers in this study reflects some of the available patient safety taxonomies in primary care25–28 and the quality of care literature.10–13 While the issues identified by patients may seem like commonly reported aspects of patient satisfaction or quality of care, these concerns were described by patients as contributing factors to safety incidents that they themselves had experienced or perceived as threats to safety in primary care. The frequent appearance of these traditional risks in the evidence base demonstrates that they continue to be problematic for patients from a safety perspective,29 and not effectively resolved in primary care. Using the YCFF to import these patient concerns into a safety perspective is unique and grounded in the patient stories themselves. The fact that eight of the contributing factors to safety incidents appear in the YCFF confirms that the findings do apply to a conceptualisation of patient safety. Furthermore, as there has been no theoretical exploration of how patient perceptions contribute to established models of patient safety,30 this study goes some way to addressing this knowledge gap. Including the patient view is a starting point to bridge the mismatch between patients and health professionals’ conceptions of safety, and allows for partnership and further development in this area.31
The findings from this study strengthen the idea that patients can observe and comment on what happens to them and what goes on around them through the whole course of their care.32 ,33 Partnering with patients and using their feedback to improve safety currently occurs in hospital settings,4 ,34 ,35 and could be applied to primary care. Patient safety reporting mechanisms and tools, such as significant event audits and root cause analysis, are important, but they are retrospective, not often used correctly, poorly designed or have had little value in improving safety.36 ,37 Furthermore, the learnings from such audits are not frequently shared across organisations.38 A prospective approach that identifies the latent and error-producing conditions in primary care from the patient perspective can assist with addressing these organisational factors before a serious event occurs.15 ,39
We recommend that tools be developed to capture patients and carers’ feedback on the contributory factors to safety incidents in primary care organisations. Primary care organisations could use such a tool to systematically identify areas of strength and weakness, address patient concerns to reduce potential harm and create a culture of safety within the practice. Questionnaires that elicit patients’ views on these contributing factors align with the growing evidence that patients can make a substantial contribution to improving safety.34 ,40 An innovative example of this type of patient feedback is the ‘Patient Measure of Safety’ that has been successfully trialled in hospital settings.4 ,34 A next step would be to develop such a questionnaire for the primary-care setting.
Strengths and limitations
There has been some research conducted, which elicits patients’ views on a single type of contributory factor. These include investigating patient typologies of medical errors and harms in primary care,41 categorising some factors contributing to safety in the medical home,42 examining patient experiences of care transition between primary and secondary43 and describing patient issues with handling of laboratory test results in general practice.44 These findings add to the evidence base in this area, but no study has actively identified a wide range of latent or error-producing factors to safety incidents in primary care from the patient perspective. Although this is a major strength of this study, there still may be some contributing factors to patient safety incidents that were not present in the data. Further research, including a systematic review, is needed to ensure that a comprehensive list of contributing factors to safety in primary care is established. This patient and carer sample may not represent all the views of primary-care patients and carers despite the high degree of complement between the findings and the international literature.45 More work needs to be undertaken to confirm if these factors or other factors are able to be identified by an international primary-care patient population.
Conclusion
Patients and carers were able to identify a comprehensive range of contributing factors to patient safety incidents in primary care. We recommend that tools be developed to systematically capture the multiple contributing factors to patient safety incidents from the patient and carer perspective. Patient and carer feedback of this type could help primary-care professionals better understand and identify potential safety concerns and make appropriate service improvements.
Acknowledgments
We thanks the patients, carers and consumers for participating in the focus groups and interviews reported in this manuscript. We also thank the health services and community organisations who assisted with recruitment of participants.
References
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
- Data supplement 1 - Online supplement
Footnotes
Twitter Follow Julie Johnson at @JulieJKJohnson
Contributors ALH conceived and designed the study. ALH and SJG were responsible for the data analysis and wrote the first draft of the manuscript. JF, JKJ, CW and JAD contributed to specific sections of the manuscript. All authors read and approved the final version of the manuscript.
Funding The research reported in this manuscript forms part of the research program of the Australian Primary Health Care Research Institute (APHCRI) Centre of Research Excellence in Primary Health Care Microsystems, and is supported by a grant from the Australian Government Department of Health and Ageing. The information and opinions contained in it do not necessarily reflect the views or policy of the APHCRI, the Australian Government, or the Department.
Competing interests None declared.
Ethics approval Flinders University Social and Behavioural Research Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
↵i Medicare is a publicly funded universal healthcare scheme in Australia. Medicare is the funder of primary healthcare for Australian citizens and permanent residents. The standard Medicare rebate is 100% for a general practitioner of the Medicare-determined schedule fee. Many medical practitioners charge more than the schedule fees, and the amount in excess of the schedule fee is paid for by the patient. Where practitioners ‘bulk bill’ patients, they agree with Medicare to accept 85% of the schedule fee in full payment for their services with no out-of-pocket expense from the patient.
↵ii The Pharmaceutical Benefits Scheme is a Federal Government scheme that subsidises the cost of medicine for most medical conditions for all Australian citizens and residents. Patients are required to copay the remaining cost of medicines not covered by the scheme.