Theorizing Factors Mediating With the Implementation of a Patient Feedback on Safety Intervention Implemented in the Primary Care Setting.

Developing safety interventions using patient feedback is valuable for creating safer systems of health care. A qualitative process evaluation of a patient feedback on safety intervention was undertaken in six primary care practices. The purpose was to theorize factors mediating with the implementation of the intervention using existing theories. The intervention required practices to obtain patient feedback on safety using a validated tool and respond using quality improvement methods. Multiple methods of qualitative data collection were used, including interviews and overt observation. Abductive reasoning informed the iterative process of analysis that examined theories relevant to the intervention and setting. A theoretical framework was developed, which encompassed mediating factors grouped under three concepts: practice readiness, utilization of problem-solving skills, and agency. Theorizing mediating factors was necessary to understand the complexities of primary care practices, and to identify the essential components for implementation of the intervention on a larger scale.

Patients' and carers' perceptions of safety in rural general practice.

OBJECTIVES: To explore patients' and carers' experiences of rural general practice to identify their perceptions of safety of care. DESIGN, PARTICIPANTS AND SETTING: Four focus group interviews were conducted with 26 rural patients and carers in south-west Victoria between September and December 2012. Frequent users of general practice were recruited from local allied health self-management programs and a mothers' group. Focus groups were audio recorded, transcripts were independently analysed and interpreted using narrative methodologies. RESULTS: Participants who had experienced some level of harm were able to comment more extensively on safety aspects of care. Several key themes related to safety were identified from the analysis of all participant narratives. An assumed sense of safety in general practice was predominant, and was influenced by participants' level of risk awareness and trust in their general practitioner. Additional unique themes included feelings of vulnerability, desire for an explanation and apology, a forgiving view of mistakes, and preference for GP interpersonal skills over competence. CONCLUSIONS: This study revealed new insights into the factors that influence patients' and carers' perspectives of safety, and demonstrated the value of incorporating the patient voice into safety research. An assumed sense of safety due to a default position of trust, coupled with limited risk perception, directly contests the current literature on patient involvement in safety. Further exploration is required to determine how patients and carers can effectively engage in and assist with improving safety in general practice.

Surveyors' perceptions of the impact of accreditation on patient safety in general practice.

OBJECTIVES: To explore Australian General Practice Accreditation Limited (AGPAL) surveyors' perceptions of the impact of accreditation on patient safety and to elicit suggestions for improving patient safety in Australian general practices. DESIGN, SETTING AND PARTICIPANTS: We conducted semi-structured telephone interviews with a purposive national sample of 10 AGPAL surveyors from 2 July to 14 December 2012. All interviews were audio recorded, transcribed and summarised. RESULTS: All participants agreed that accreditation has improved general practices' performance in quality and safety. Participants noted specific areas that need further attention, including sufficient evidence for clinical risk management, which half the participants estimated occurs in about 5%-10% of Australian general practices. Tangible evidence of patient safety activities included having a significant incidents register, providing documentation of near misses, slips, lapses or mistakes, and engaging in regular clinical meetings to discuss incidents and how to avoid them in the future. Participants agreed that the accreditation process could be improved through the inclusion of tighter clinical safety indicators and the requirement of verifiable evidence of a working clinical risk management system. CONCLUSIONS: Accreditation has had a positive role in improving quality and safety in general practice. The inclusion of tighter indicators that require verifiable evidence will be a step forward. The Australian Primary Care Collaboratives (APCC) Program has an opportunity to build on its previous success in general practice quality improvement to further enhance patient safety in general practice.

Association of weight misperception with weight loss in a diabetes prevention program.

BACKGROUND: Weight misperception may have an impact on perceived risk and susceptibility for chronic diseases. Little has been reported on the long term effects of this misperception in chronic disease interventions, particularly in field of diabetes prevention. The aim of this study was to investigate the relationship between weight misperception and weight loss during a diabetes prevention project conducted in south-east Australia with individuals at moderate to high risk of developing diabetes. METHODS: A total of n=251 at risk individuals provided self-reported weight during recruitment from 2004-2006. Objectively measured weight was assessed at baseline (0-21 days after recruitment), and subsequently at three months and 12 months after the intervention. Differences between self-reported and actual weight status are presented as percentages. Linear regression was used to investigate the relationship between weight misperception and weight loss, adjusting for baseline weight and BMI. RESULTS: Those who had high levels of under-reporting at baseline had greater weight loss at three and 12 months compared with those who under-reported to some degree, and those over-reporting their weight. A significant association was found between weight misperception and weight loss at the three and the 12 month time points. Baseline weight was not associated with weight loss. CONCLUSIONS: Weight misperception should be acknowledged as a factor to be addressed when screening and identifying individuals at risk for diabetes. Screening and giving feedback is important in terms of awareness of participants' actual weight status and may have an effect on program outcomes.

Implementation of diabetes prevention programs in rural areas: Montana and south-eastern Australia compared.

OBJECTIVE: To identify the key elements that enabled the Greater Green Triangle Diabetes Prevention Project (GGT DPP) and the Montana Cardiovascular Disease and Diabetes Prevention (CDDP) programs successful establishment and implementation in rural areas, as well as identifying specific challenges or barriers for implementation in rural communities. METHODS: Focus groups were held with the facilitators who delivered the GGT DPP in Australia and the Montana CDDP programs in the USA. Interview questions covered the facilitators' experiences with recruitment, establishing the program, the components and influence of rurality on the program, barriers and challenges to delivering the program, attributes of successful participants, and the influence of community resources and partnerships on the programs. RESULTS: Four main themes emerged from the focus groups: establishing and implementing the diabetes prevention program in the community; strategies for recruitment and retention of participants; what works in lifestyle intervention programs; and rural-centred issues. CONCLUSIONS: The results from this study have assisted in determining the factors that contribute to developing, establishing and implementing successful diabetes prevention programs in two rural areas. Recommendations to increase the likelihood of success of programs in rural communities include: securing funding early for the program; establishing support from community leaders and developing positive relationships with health care providers; creating a professional team with passion for the program; encouraging participants to celebrate their small and big successes; and developing procedures for providing post-intervention support to help participants maintain their success.

Nature and type of patient-reported safety incidents in primary care: cross-sectional survey of patients from Australia and England.

BACKGROUND: Patient engagement in safety has shown positive effects in preventing or reducing adverse events and potential safety risks. Capturing and utilising patient-reported safety incident data can be used for service learning and improvement. OBJECTIVE: The aim of this study was to characterise the nature of patient-reported safety incidents in primary care. DESIGN: Secondary analysis of two cross sectional studies. PARTICIPANTS: Adult patients from Australian and English primary care settings. MEASURES: Patients' self-reported experiences of safety incidents were captured using the validated Primary Care Patient Measure of Safety questionnaire. Qualitative responses to survey items were analysed and categorised using the Primary Care Patient Safety Classification System. The frequency and type of safety incidents, contributory factors, and patient and system level outcomes are presented. RESULTS: A total of 1329 patients (n=490, England; n=839, Australia) completed the questionnaire. Overall, 5.3% (n=69) of patients reported a safety incident over the preceding 12 months. The most common incident types were administration incidents (n=27, 31%) (mainly delays in accessing a physician) and incidents involving diagnosis and assessment (n=16, 18.4%). Organisation of care accounted for 27.6% (n=29) of the contributory factors identified in the safety incidents. Staff factors (n=13, 12.4%) was the second most commonly reported contributory factor. Where an outcome could be determined, patient inconvenience (n=24, 28.6%) and clinical harm (n=21, 25%) (psychological distress and unpleasant experience) were the most frequent. CONCLUSIONS: The nature and outcomes of patient-reported incidents differ markedly from those identified in studies of staff-reported incidents. The findings from this study emphasise the importance of capturing patient-reported safety incidents in the primary care setting. The patient perspective can complement existing sources of safety intelligence with the potential for service improvement.

Patient feedback for safety improvement in primary care: results from a feasibility study.

OBJECTIVES: Patient involvement in safety improvement is a developing area of research. The aim of this study was to investigate the feasibility of a patient feedback on safety intervention in primary care. Specifically, the intervention acceptability, fidelity, implementation enablers and barriers, scalability, and process of systematically collecting safety data were examined. DESIGN, SETTING AND PARTICIPANTS: Mixed-methods feasibility trial with six purposively selected Australian primary care practices. INTERVENTION: The intervention comprised an iterative process with a cycle of measurement, learning, feedback, action planning and implementation period of 6 months. PRIMARY AND SECONDARY OUTCOMES: Qualitative and quantitative data relating to feasibility measures (acceptability, fidelity, enablers, barriers, scalability and process of collecting safety data) were collected and analysed. RESULTS: A total of n=1750 patients provided feedback on safety. There was a statistically significant increase in mean patient safety scores indicating improved safety (4.30-4.37, p=0.002). Staff deemed the intervention acceptable, with minor recommendations for improvement. Intervention fidelity was high and implementation enablers were attributed to the intervention structure and framework, use of intuitive problem-solving approaches, and multidisciplinary team involvement. Practice-based safety interventions resulted in sustainable and measurable changes to systems for safety, such as increased access to care and improved patient information accuracy. CONCLUSIONS: The findings indicate that this innovative patient feedback on safety intervention is feasible for scale-up to a larger effectiveness trial and further spread into policy and practice. This intervention complements existing safety improvement strategies and activities, and integrates into current patient feedback service requirements for Australian primary care. Further research is needed to examine the intervention effects on safety incident reduction.

Validation of the Primary Care Patient Measure of Safety (PC PMOS) questionnaire.

BACKGROUND: The Primary Care Patient Measure of Safety (PC PMOS) is designed to capture patient feedback about the contributing factors to patient safety incidents in primary care. It required further reliability and validity testing to produce a robust tool intended to improve safety in practice. METHOD: 490 adult patients in nine primary care practices in Greater Manchester, UK, completed the PC PMOS. Practice staff (n = 81) completed a survey on patient safety culture to assess convergent validity. Confirmatory factor analysis (CFA) assessed the construct validity and internal reliability of the PC PMOS domains and items. A multivariate analysis of variance was conducted to assess discriminant validity, and Spearman correlation was conducted to establish test-retest reliability. RESULTS: Initial CFA results showed data did not fit the model well (a chi-square to df ratio (CMIN/DF) = 5.68; goodness-of-fit index (GFI) = 0.61, CFI = 0.57, SRMR = 0.13 and root mean square error of approximation (RMSEA) = 0.10). On the basis of large modification indices (>10), standardised residuals >± 2.58 and assessment of item content; 22 items were removed. This revised nine-factor model (28 items) was found to fit the data satisfactorily (CMIN/DF = 2.51; GFI = 0.87, CFI = 0.91, SRMR = 0.04 and RMSEA = 0.05). New factors demonstrated good internal reliability with average inter-item correlations ranging from 0.20 to 0.70. The PC PMOS demonstrated good discriminant validity between primary care practices (F = 2.64, df = 72, p < 0.001) and showed some association with practice staff safety score (convergent validity) but failed to reach statistical significance (r = -0.64, k = 9, p = 0.06). CONCLUSION: This study led to a reliable and valid 28-item PC PMOS. It could enhance or complement current data collection methods used in primary care to identify and prevent error.

Investigating the feasibility of a patient feedback tool to improve safety in Australian primary care: a study protocol.

INTRODUCTION: Patients are a valuable source of information about ways to prevent harm in healthcare, and can provide feedback about the factors that contribute to safety incidents. The Primary Care Patient Measure of Safety (PC PMOS) is a novel and validated tool that captures patient feedback on safety and can be used by primary care practice teams to identify and prevent safety incidents. The aim of this study is to assess the feasibility of PC PMOS as a tool for data-driven safety improvement and monitoring in Australian primary care. METHODS AND ANALYSIS: Feasibility will be assessed using a mixed-methods approach to understand the enablers, barriers, acceptability, practicability, intervention fidelity and scalability of C PMOS as a tool for safety improvement across six primary care practices in the south-west region of Victoria. Patients over the age of 18 years attending their primary care practice will be invited to complete the PC PMOS when presenting for an appointment. Staff members at each practice will form a safety improvement team. Staff will then use the patient feedback to develop and implement specific safety interventions over a 6-month period. Data collection methods during the intervention period includes audio recordings of staff meetings, overt observations at training and education workshops, reflexive researcher insights, document collection and review. Data collection postintervention includes patient completion of the PC PMOS and semistructured interviews with staff. Triangulation and thematic analysis techniques will be employed to analyse the qualitative and content data. Analysis methods will use current evidence and models of healthcare culture, safety improvement and patient involvement in safety to inform the findings. ETHICS AND DISSEMINATION: Ethics approval was granted by Deakin University Human Ethics Advisory Group, Faculty of Health (HEAG-H 175_2017). Study results will be disseminated through local and international conferences and peer-reviewed publications.

Developing a primary care patient measure of safety (PC PMOS): a modified Delphi process and face validity testing.

BACKGROUND: Patients are a valuable source of information about ways to prevent harm in primary care and are in a unique position to provide feedback about the factors that contribute to safety incidents. Unlike in the hospital setting, there are currently no tools that allow the systematic capture of this information from patients. The aim of this study was to develop a quantitative primary care patient measure of safety (PC PMOS). METHODS: A two-stage approach was undertaken to develop questionnaire domains and items. Stage 1 involved a modified Delphi process. An expert panel reached consensus on domains and items based on three sources of information (validated hospital PMOS, previous research conducted by our study team and literature on threats to patient safety). Stage 2 involved testing the face validity of the questionnaire developed during stage 1 with patients and primary care staff using the 'think aloud' method. Following this process, the questionnaire was revised accordingly. RESULTS: The PC PMOS was received positively by both patients and staff during face validity testing. Barriers to completion included the length, relevance and clarity of questions. The final PC PMOS consisted of 50 items across 15 domains. The contributory factors to safety incidents centred on communication, access to care, patient-related factors, organisation and care planning, task performance and information flow. DISCUSSION: This is the first tool specifically designed for primary care settings, which allows patients to provide feedback about factors contributing to potential safety incidents. The PC PMOS provides a way for primary care organisations to learn about safety from the patient perspective and make service improvements with the aim of reducing harm in this setting. Future research will explore the reliability and construct validity of the PC PMOS.

Patient and carer identified factors which contribute to safety incidents in primary care: a qualitative study.

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.

Challenges of diabetes prevention in the real world: results and lessons from the Melbourne Diabetes Prevention Study.

OBJECTIVE: To assess effectiveness and implementability of the public health programme Life! Taking action on diabetes in Australian people at risk of developing type 2 diabetes. RESEARCH DESIGN AND METHODS: Melbourne Diabetes Prevention Study (MDPS) was a unique study assessing effectiveness of Life! that used a randomized controlled trial design. Intervention participants with AUSDRISK score ≥15 received 1 individual and 5 structured 90 min group sessions. Controls received usual care. Outcome measures were obtained for all participants at baseline and 12 months and, additionally, for intervention participants at 3 months. Per protocol set (PPS) and intention to treat (ITT) analyses were performed. RESULTS: PPS analyses were considered more informative from our study. In PPS analyses, intervention participants significantly improved in weight (-1.13 kg, p=0.016), waist circumference (-1.35 cm, p=0.044), systolic (-5.2 mm Hg, p=0.028) and diastolic blood pressure (-3.2 mm Hg, p=0.030) compared with controls. Based on observed weight change, estimated risk of developing diabetes reduced by 9.6% in the intervention and increased by 3.3% in control participants. Absolute 5-year cardiovascular disease (CVD) risk reduced significantly for intervention participants by 0.97 percentage points from 9.35% (10.4% relative risk reduction). In control participants, the risk increased by 0.11 percentage points (1.3% relative risk increase). The net effect for the change in CVD risk was -1.08 percentage points of absolute risk (p=0.013). CONCLUSIONS: MDPS effectively reduced the risk of diabetes and CVD, but the intervention effect on weight and waist reduction was modest due to the challenges in recruiting high-risk individuals and the abbreviated intervention.