Summary of main outcomes
The PRisM program did not increase the healthcare professional reporting rate of PSIs per FTE years; however, there was significant variability between facilities concerning the implementation of the program. While all facilities designated their own RMA, only 7 out of 17 facilities carried out the entire EFC-MMC cycle and had > 80% of healthcare professionals complete trained by e-learning, while 4 facilities partially completed the cycle, with approximately 40% of professionals completing training. The PP analysis with these 11 facilities showed a statistically significant effect of the program on PSI rate in the model that included the pre-intervention period, which suggests that the PRisM program promotes sustained PSI reporting over time but does not improve PSI reporting by healthcare professionals. Overall, 230 and 222 PSIs were reported in the pre-intervention and intervention periods, respectively, and were frequently related to errors in practice and the healthcare system or errors related to medication. There were few severe adverse patient outcomes, with the main contributing factors relating to care processes or human factors. Consequences regarding facilities mainly involved a loss in patient confidence and changes at the organisational level. Corrective measures were identified more frequently related to the organisation within the facility or the medical training and care practice. Thus, our work improves understanding of the nature of the most frequent and serious PSIs in primary care, the associated contributing factors and, more remarkably, the corrective measures implemented.
Comparison with existing literature
It is essential to promote the implementation of risk management systems in facilities given their increasingly important role in primary care [32, 33]. To achieve this goal, it would appear advisable to design an intervention that would combine several elements recommended for improving patient safety in primary care [8]. In the PRisM study, the PSI rate, following the implementation of a reporting system without additional interventions, reaches 0.8 per Full-Time Equivalent (FTE) year, in the pre-intervention period in contrast to about 0.2–0.3 estimated from other studies [5, 27, 34]. The decreased rate of reported PSIs over time needs comment, as it was observed in both arms. As suggested by the relatively high basal PSI rate in the PRisM study, we postulate an overestimation in the pre-interventional period and weariness among professionals to report over time, rather than a decrease in reported PSIs linked to the implementation of efficient corrective measures (which would be more important in the intervention arm). As previously suggested [12], the declining trend in reporting could also be explained by the greater involvement of facilities at the beginning, due to urgent safety issues to be reported for processing. Once resolved, they may reduce their level of involvement. Moreover, assignment to the control arm may have demotivated some teams from participating [34], despite access to the program at the end of the study. However, the intervention was observed to sustain a certain basal level of PSI reporting with a post-intervention PSI rate of 0.45 per FTE year vs 0.24 in the control arm, more comparable to other [5, 27, 34]. The literature consistently highlights an underreporting of PSI by professionals [35], even in case of an intervention dedicated to support patient safety culture in primary care [34]. In addition, in the PRisM study the standard deviation of the PSI rate was high, similar to the result itself. In our opinion, this reflects a wide disparity between facilities when it comes to reporting incidents, as it was previously observed [12]. PSIs related to errors in the organisation of the healthcare system, or related to medications were most frequent reported, an observation that has been identified previously [3, 4, 36]. In response, considering alternative strategies, such as trigger tools emerges as a promising avenue. The contributing factors identified according to CADYA [22, 23] are consistent with data from a previous French national study [17, 23], in which almost a third of CFs were related to human factors. The PRisM study also enabled us to explore the development of corrective measures by healthcare professionals. In nearly 90% of incidents, healthcare professionals proposed at least one measure, which is remarkable. The fact that these corrective measures concerned training and organisation within the facilities, representing nearly 2/3 of PSIs, indicates that it is possible to promote an integrated approach to improving the quality and safety of care.
Strengths and limitations
The primary outcome of this study was the reporting rate of PSIs per FTE year, which is one of the most widely used patient safety indicators. Others outcome measures, such as the safety climate or data on patient morbidity-mortality, may have been more suitable. However, to assess the safety climate remains difficult and data on morbidity-mortality could suffers from a relatively low frequency of severe incidents observed in primary care [17], which raises the question of their representativeness. Regarding the choice of taxonomy used for PSI analysis, the WHO International Classification for Patient Safety allows for coding all elements of systemic analysis (dysfunctions, consequences, etc.) [37]. As it seems to be more complex to use, we have opted for a method that separates out all the elements; for instance, the TAPS taxonomy for the nature of PSI, considering its international applicability (facilitating comparisons) [3, 21]. Additionally, for the classification of dysfunctions, we employed the CADYA classification [23] supported by the French High Health Authority for the analysis of incidents in primary care.
The PRisM intervention aimed to provide key components of an integrated risk management system in a primary care facility. Multiprofessional facilities is a recent modality in France and, therefore, we focused on healthcare professionals. The patients were not explicitly encouraged to report incidents. However, several incident reports stemmed from patient detection, which was subsequently reported to the healthcare professional. Patient involvement should be considered in future studies, especially in PSI reporting as it constitutes an underutilized source in primary care.
Teamwork itself influences the implementation of a risk management program [38] as much as it can itself benefit from it [39]. Although a limitation of this work is that teamwork was not specifically addressed by the study program, the e-learning modules provided instructions on how to run a multiprofessional meeting and the EFC-MMC cycle strongly involved a teamwork dimension. The mean duration of activity varied among professionals and the existence of strong and long-standing team dynamics as a prerequisite for successful intervention has not been explored [40]. Barriers to PSI reporting by healthcare professionals have been identified [41]; however, these are not specific to primary care. Barriers such as the fear of legal consequences may not have been sufficiently addressed in the e-learning module implemented in this study. To assess the reporting rate of PSIs, a cluster-randomised controlled trial was preferred to a stepped wedge randomised controlled trial design [42] because the risk of contamination bias was small, given the distribution of facilities across the country. Although a stepped wedge design would have provided the intervention to all facilities, the full program was freely available to all facilities after the study. Prior to the study, we postulate the risk that the facilities would be very heterogeneous and that it could be difficult to implement the program. The benefits of including a PP analysis (to explore the effect of truly receiving the PRisM program) was considered, in addition to the main ITT analysis. The main limitation of this study remains the lack of statistical power as 35 facilities were randomised instead of 50 that were initially intended, which highlights the difficulty of enrolling professionals to participate in research in primary care in France [43]. Indeed, with 17 facilities enrolled per arm instead of 25, the power to conclude to a difference between the two groups is 76% instead of 90% expected, even if the number of enrolled FTEs exceeds the expected 500, due to several facilities with over 50 professionals. Furthermore, the facilities were located throughout the country and were, therefore, representative of multiprofessional primary care facility organisations in France. Moreover, while GPs constitute the majority of healthcare professionals, a strength of this study is that a diverse range of professionals, including nurses and, to a lesser degree, physiotherapists, were well represented. Indeed, PSI reporting is known to be enhanced in facilities comprising several types of professionals [12].
Implications for research and/or practice
The observation that the reporting of PSIs by professionals continued in the intervention group suggests the program had a positive effect on reporting dynamic. Thus, the reporting dynamic could be sustainable, subject to a minimum of consideration for patient safety in teamwork. However, as observed in other study [34] program implementation varied significantly between facilities, emphasizing that teamwork dynamic within a facility is a key factor [44]. Generic barriers and facilitators have already been identified in the literature [45], but they are not specific for primary care. A qualitative study led by a sociologist was conducted to assess the barriers and facilitators to the PRisM program among primary care facilities. Several aspects of the program seemed to have worked well, such as the identification of an RMA, which was effective in all facilities. This RMA was, in many cases, the person who had the greatest leadership over the team. It would seem appropriate to rely on this person each time in the context of a quality and safety approach [46], but this was not always sufficient. This finding is consistent with other studies suggesting that strong leadership devoted to patient safety constitutes a key factor in developing a favourable patient safety climate [47]. Our future work will aim to identify the organisational and leadership arrangements in facilities that are most likely to result in the successful implementation of risk management programs.
Although the PSI reporting system was designed to be ergonomic, we can probably assume that the time associated with collecting data, in addition to the existing information system, constituted a barrier after initial enthusiasm for the program waned. It would, therefore, seem necessary to consider the possibility of integrating PSI reporting through the medical chart system and/or facilitating automatic data extraction. As suggested by the results of the qualitative study conducted at the end of our study, we propose the integration of a simple checkbox to indicate a potential PSI in the medical chart to subsequently facilitate their exploitation. Logistical support (i.e., regarding the analysis of documents or PSI reporting system use) is a key element for a successful program. In France, such methodological support is already offered to teams in hospitals through dedicated services. Durable support should also be provided through regional support structures for primary care facilities. As a related issue, there is currently no specific indicator related to patient safety in the maturity matrix of primary care structures in France [25]. As a result, the assessment of patient safety remains formally underdeveloped, primarily relying on indicators of medication-related harm, focusing more on prescribing professionals than on the facilities themselves.
Regarding the modalities of analysis in the structures, EFC or MMC meetings appear as viable solutions as they may contribute fostering a culture of reporting PSIs since incidents are processed by the team itself [15, 47]. These meetings should be strongly promoted by public authorities via specific funding for the facilities implementing them. The collection of improvement measures related to PSI occurrence and their dissemination to other structures may represent an opportunity.
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