Can using the functional resonance analysis method, as an intervention, improve patient safety in hospitals?: a stepped wedge design protocol.

BACKGROUND: Healthcare professionals are sometimes forced to adjust their work to varying conditions leading to discrepancies between hospital protocols and daily practice. We will examine the discrepancies between protocols, 'Work As Imagined' (WAI), and daily practice 'Work As Done' (WAD) to determine whether these adjustments are deliberate or accidental. The discrepancies between WAI and WAD can be visualised using the Functional Resonance Analysis Method (FRAM). FRAM will be applied to three patient safety themes: risk screening of the frail older patients; the administration of high-risk medication; and performing medication reconciliation at discharge. METHODS: A stepped wedge design will be used to collect data over 16 months. The FRAM intervention consists of constructing WAI and WAD models by analysing hospital protocols and interviewing healthcare professionals, and a meeting with healthcare professionals in each ward to discuss the discrepancies between WAI and WAD. Safety indicators will be collected to monitor compliance rates. Additionally, the potential differences in resilience levels among nurses before and after the FRAM intervention will be measured using the Employee Resilience Scale (EmpRes) questionnaire. Lastly, we will monitor whether gaining insight into differences between WAI and WAD has led to behavioural and organisational change. DISCUSSION: This article will assess whether using FRAM to reveal possible discrepancies between hospital protocols (WAI) and daily practice (WAD) will improve compliance with safety indicators and employee resilience, and whether these insights will lead to behavioural and organisational change. TRIAL REGISTRATION: Netherlands Trial Register NL8778; https://www.trialregister.nl/trial/8778 . Registered 16 July 2020. Retrospectively registered.

Interruptions during intravenous medication administration: A multicentre observational study.

AIMS: The aim of this study was to determine the frequency and cause of interruptions during intravenous medication administration, which factors are associated with interruptions and to what extent interruptions influence protocol compliance. BACKGROUND: Hospital nurses are frequently interrupted during medication administration, which contributes to the occurrence of administration errors. Errors with intravenous medication are especially worrisome, given their immediate therapeutic effects. However, knowledge about the extent and type of interruptions during intravenous medication administration is limited. DESIGN: Multicentre observational study. METHODS: Data were collected during two national evaluation studies (2011 - 2012 & 2015 - 2016). Nurses were directly observed during intravenous medication administration. An interruption was defined as a situation where a break during the administration was needed or where a nurse was distracted but could process without a break. Interruptions were categorized according to source and cause. Multilevel logistic regression analyses were conducted to assess the associations between explanatory variables and interruptions or complete protocol compliance. RESULTS: In total, 2,526 intravenous medication administration processes were observed. During 291 (12%) observations, nurses were interrupted 321 times. Most interruptions were externally initiated by other nurses (19%) or patients (19%). Less interruptions occurred during the evening (odds ratio: 0.23 [95% confidence interval: 0.08-0.62]). Do-not-disturb vests were worn by 61 (2%) nurses. No significant association was found between being interrupted and complete protocol compliance. CONCLUSION: An interruption occurred in every eight observed intravenous medication administration, mainly caused by other nurses or patients. One needs to consider critically which strategies effectively improve safety during the high-risk nursing-task of intravenous medication administration.

Evaluating deviations and considerations in daily practice when double-checking high-risk medication administration: A qualitative study using the FRAM.

Background: Double-check protocol compliance during administration is low. Regardless, most high-risk medication administrations are performed without incidents. The present study investigated the process of preparing and administrating high-risk medication and examined which variations occur in daily practice. Additionally, we investigated which considerations were taken into account when deviating from the guidelines. Methods: Ten Dutch hospital wards participated. The Functional Resonance Analysis Method was applied to construct a model depicting the Dutch guidelines and a ward-overarching model visualizing daily practice. To create the ward-overarching model, eight semi-structured interviews were conducted per ward discussing the preparation and administration of high-risk medication. Work related Efficiency-Thoroughness Trade-Off rules were used to structure subconscious considerations. Results: In total, 77 nurses were interviewed. Six model deviations were found between the guideline model and ward-overarching model. Notably, four variations in double-check procedures were found. Here, time pressure was an important factor. Nurses made a risk-assessment, considering for patient stability, and difficulty of calculations, to determine whether the double-check would be executed. Additionally, subconscious reasonings, such as trusting their own or colleagues expertise, weighed on the decision. Conclusion: Time pressure is the most important factor that withholds nurses from performing the double-check. Nurses instead conduct a risk-assessment to decide if the double-check will be executed. The double-check can thus become habitual or unnecessary for certain medications. In future research, insights of the FRAM could be used to make ward-specific alterations for the double-check procedure of medications, that focus on feasibility in daily practice, while maintaining patient safety.

Occurrence of Antithrombotic Related Adverse Events in Hospitalized Patients: Incidence and Clinical Context between 2008 and 2016.

Antithrombotic drugs are consistently involved in medication-related adverse events (MRAEs) in hospitalized patients. We aimed to estimate the antithrombotic-related adverse event (ARAE) incidence between 2008 and 2016 and analyse their clinical context in hospitalized patients in The Netherlands. A post-hoc analysis of three national studies, aimed at adverse event (AE) identification, was performed. Previously identified AEs were screened for antithrombotic involvement. Crude and multi-level, case-mix adjusted ARAE and MRAE incidences were calculated. Various contextual ARAE characteristics were analysed. ARAE incidence between 2008 and 2016 decreased significantly in in-hospital deceased patients from 1.20% (95% confidence interval (CI): 0.63-2.27%) in 2008 to 0.54% (95% CI: 0.27-1.11%) in 2015/2016 (p = 0.02). In discharged patients ARAE incidence remained stable. By comparison, overall MRAE incidence remained stable for both deceased and discharged patients. Most ARAEs involved Vitamin-K antagonists (VKAs). Preventable ARAEs occurred more during weekends and with increasing multidisciplinary involvement. Antiplatelet and combined antithrombotic use seemed to be increasingly involved in ARAEs over time. ARAE incidence declined by 55% in deceased patients between 2008 and 2016. Opportunities for improving antithrombotic safety should target INR monitoring and care delivery aspects such as multidisciplinary involvement and weekend care. Future ARAE monitoring for the involvement of antiplatelet, combined antithrombotic and direct oral anticoagulant (DOAC) use is recommended.