The national perinatal patient safety programme : the challenges of implementation and evaluation

Sammanfattning: Background: Factors resulting in suboptimal care might be avoided by training and increased risk awareness. The Swedish Perinatal Patient Safety (PPS) programme was initiated in 2008 and a web-based CTG learning programme was launched in 2009. The objective of this thesis was to evaluate the impact and effects of a national programme to improve safety for the newborn by studying how the interventions affected professional teams, their knowledge in assessing cardiotochography, and by exploring local improvement efforts, as well as perinatal outcomes, before and after the main intervention i.e. the PPS programme. Material and method: In Paper I semi-structured interviews explored how the core interventions affected the local teams and their mental models of patient safety improvement and readiness for change. In Paper II midwives and physicians classified one CTG tracing before and after getting access to the web-based learning programme in fetal surveillance. In Paper III midwives and physicians classified one CTG tracing individually and one pairwise. In Paper IV, multiple methods were used for data collection and analyses: a) the final reports from all 46 obstetric units were analysed, b) Apgar score <7 at 5 minutes (=asphyxia) before and after the PPS programme was assessed and c) quarterly cumulative incidence of newborns granted financial compensation from LÖF due to delivery related asphyxia during 2000-15 were analysed. Paper V was a criterion-based review of care processes during labour and delivery. Cases with asphyxia and controls with full Apgar were retrieved after the PPS programme and compared with data from a previous study. Results: Self-assessment was a useful tool at the units and new team mental models about patient safety improvement emerged during the process. The peer review process was appreciated, but had no explicit connection to any measurable effects (Paper I). No significant improvement was seen after education (Paper II). There was no significant difference when CTG’s were classified pairwise compared to individual classifications. (Paper III). In the final reports, 4/5 of units reported improved guidelines. New process measures and/or follow-up of outcome measures were reported in half of the units. The incidence of asphyxia remained unchanged. The incidence of settled claims showed a decreasing trend, 2012-14 (Paper IV). Supervision of fetal well-being was more often neglected after the PPS programme in both cases and controls. The odds for an overall risk of incautious management of oxytocin more than doubled, while the risk for traumatic instrumental delivery decreased significantly among cases (Paper V). Conclusions: Extensive improvement efforts have been made in all obstetric units in Sweden. However, our results show that there are still gaps in delivery care that need improvement. When investing time and resources in multifaceted projects, it is crucial to evaluate results in order to assess the benefits of the intervention and at the same time, understand facilitating and restricting features of implementation. Evaluation, however, is challenging in large-scale quality improvements with a diversity of actors interacting in complex environments that are constantly changing. To secure a variety of evidencebased process and outcome measures already when planning the project, improves the chances of successful evaluation. Then it will be possible to continuously follow-up adherence and measure reliability in care processes.