Increased adherence to perioperative safety guidelines associated with improved patient safety outcomes: a stepped-wedge, cluster-randomised multicentre trial.

BACKGROUND: National Dutch guidelines have been introduced to improve suboptimal perioperative care. A multifaceted implementation programme (IMPlementatie Richtlijnen Operatieve VEiligheid [IMPROVE]) has been developed to support hospitals in applying these guidelines. This study evaluated the effectiveness of IMPROVE on guideline adherence and the association between guideline adherence and patient safety. METHODS: Nine hospitals participated in this unblinded, superiority, stepped-wedge, cluster RCT in patients with major noncardiac surgery (mortality risk ≥1%). IMPROVE consisted of educational activities, audit and feedback, reminders, organisational, team-directed, and patient-mediated activities. The primary outcome of the study was guideline adherence measured by nine patient safety indicators on the process (stop moments from the composite STOP bundle, and timely administration of antibiotics) and on the structure of perioperative care. Secondary safety outcomes included in-hospital complications, postoperative wound infections, mortality, length of hospital stay, and unplanned care. RESULTS: Data were analysed for 1934 patients. The IMPROVE programme improved one stop moment: 'discharge from recovery room' (+16%; 95% confidence interval [CI], 9-23%). This stop moment was related to decreased mortality (-3%; 95% CI, -4% to -1%), fewer complications (-8%; 95% CI, -13% to -3%), and fewer unscheduled transfers to the ICU (-6%; 95% CI, -9% to -3%). IMPROVE negatively affected one other stop moment - 'discharge from the hospital' - possibly because of the limited resources of hospitals to improve all stop moments together. CONCLUSIONS: Mixed implementation effects of IMPROVE were found. We found some positive associations between guideline adherence and patient safety (i.e. mortality, complications, and unscheduled transfers to the ICU) except for the timely administration of antibiotics. CLINICAL TRIAL REGISTRATION: NTR3568 (Dutch Trial Registry).

Complexity and involvement as implementation challenges: results from a process analysis.

BACKGROUND: The study objective was to analyse the implementation challenges experienced in carrying out the IMPROVE programme. This programme was designed to implement checklist-related improvement initiatives based on the national perioperative guidelines using a stepped-wedge trial design. A process analysis was carried out to investigate the involvement in the implementation activities. METHODS: An involvement rating measure was developed to express the extent to which the implementation programme was carried out in the hospitals. This measure reflects the number of IMPROVE-implementation activities executed and the estimated participation in these activities in all nine participating hospitals. These data were compared with prospectively collected field notes. RESULTS: Considerable variation between the hospitals was found with involvement ratings ranging from 0 to 6 (mean per measurement = 1.83 on a scale of 0-11). Major implementation challenges were respectively the study design (fixed design, time planning, long duration, repeated measurements, and data availability); the selection process of hospitals, departments and key contact person(s) (inadequately covering the entire perioperative team and stand-alone surgeons); the implementation programme (programme size and scope, tailoring, multicentre, lack of mandate, co-interventions by the Inspectorate, local intervention initiatives, intervention fatigue); and competitive events such as hospital mergers or the introduction of new IT systems, all reducing involvement. CONCLUSIONS: The process analysis approach helped to explain the limited and delayed execution of the IMPROVE-implementation programme. This turned out to be very heterogeneous between hospitals, with variation in the number and content of implementation activities carried out. The identified implementation challenges reflect a high complexity with regard to the implementation programme, study design and setting. The involvement of the target professionals was put under pressure by many factors. We mostly encountered challenges, but at the same time we provide solutions for addressing them. A less complex implementation programme, a less fixed study design, a better thought-out selection of contact persons, as well as more commitment of the hospital management and surgeons would likely have contributed to better implementation results. TRIAL REGISTRATION: Dutch Trial Registry: NTR3568 , retrospectively registered on 2 August 2012.

Reducing work pressure and IT problems and facilitating IT integration and audit & feedback help adherence to perioperative safety guidelines: a survey among 95 perioperative professionals.

BACKGROUND: To improve perioperative patient safety, guidelines for the preoperative, peroperative, and postoperative phase were introduced in the Netherlands between 2010 and 2013. To help the implementation of these guidelines, we aimed to get a better understanding of the barriers and drivers of perioperative guideline adherence and to explore what can be learned for future implementation projects in complex organizations. METHODS: We developed a questionnaire survey based on the theoretical framework of Van Sluisveld et al. for classifying barriers and facilitators. The questionnaire contained 57 statements derived from (a) an instrument for measuring determinants of innovations by the Dutch Organization for Applied Scientific Research, (b) interviews with quality and safety policy officers and perioperative professionals, and (c) a publication of Cabana et al. The target group consisted of 232 perioperative professionals in nine hospitals. In addition to rating the statements on a five-point Likert scale (which were classified into the seven categories of the framework: factors relating to the intervention, society, implementation, organization, professional, patients, and social factors), respondents were invited to rank their three most important barriers in a separate, extra open-ended question. RESULTS: Ninety-five professionals (41%) completed the questionnaire. Fifteen statements (26%) were considered to be barriers, relating to social factors (N = 5), the organization (N = 4), the professional (N = 4), the patient (N = 1), and the intervention (N = 1). An integrated information system was considered an important facilitator (70.4%) as well as audit and feedback (41.8%). The Barriers Top-3 question resulted in 75 different barriers in nearly all categories. The most frequently reported barriers were as follows: time pressure (16% of the total number of barriers), emergency patients (8%), inefficient IT structure (4%), and workload (3%). CONCLUSIONS: We identified a wide range of barriers that are believed to hinder the use of the perioperative safety guidelines, while an integrated information system and local data collection and feedback will also be necessary to engage perioperative teams. These barriers need to be locally prioritized and addressed by tailored implementation strategies. These results may also be of relevance for guideline implementation in general in complex organizations. TRIAL REGISTRATION: Dutch Trial Registry: NTR3568.

Improving the implementation of perioperative safety guidelines using a multifaceted intervention approach: protocol of the IMPROVE study, a stepped wedge cluster randomized trial.

BACKGROUND: This study is initiated to evaluate the effects, costs, and feasibility at the hospital and patient level of an evidence-based strategy to improve the use of Dutch perioperative safety guidelines. Based on current knowledge, expert opinions and expertise of the project team, a multifaceted implementation strategy has been developed. METHODS/DESIGN: This is a stepped wedge cluster randomized trial including nine representative hospitals across The Netherlands. Hospitals are stratified into three groups according to hospital type and geographical location and randomized in terms of the period for receipt of the intervention. All adult surgical patients meeting the inclusion criteria are assessed for patient outcomes. The implementation strategy includes education, audit and feedback, organizational interventions (e.g., local embedding of the guidelines), team-directed interventions (e.g., multi-professional team training), reminders, as well as patient-mediated interventions (e.g., patient safety cards). To tailor the implementation activities, we developed a questionnaire to identify barriers for effective guideline adherence, based on (a) a theoretical framework for classifying barriers and facilitators, (b) an instrument for measuring determinants of innovations, and (c) 19 semi-structured interviews with perioperative key professionals. Primary outcome is guideline adherence measured at the hospital (i.e., cluster) and patient levels by a set of perioperative Patient Safety Indicators (PSIs), which was developed parallel to the perioperative guidelines. Secondary outcomes at the patient level are in-hospital complications, postoperative wound infections and mortality, length of hospital stay, and unscheduled transfer to the intensive care unit, non-elective readmission to the hospital and unplanned reoperation, all within 30 days after the initial surgery. Also, patient safety culture and team climate will be studied as potential determinants. Finally, a process evaluation is conducted to identify the compliance with the implementation strategy, as well as an economic evaluation to assess the costs. Data sources are registered clinical data and surveys. There is no form of blinding. DISCUSSION: The perioperative setting is an unexplored area with respect to implementation issues. This study is expected to yield important new evidence about the effects of a multifaceted approach on guideline adherence in the perioperative care setting. TRIAL REGISTRATION: Dutch trial registry: NTR3568.

The impact of a standardized incident reporting system in the perioperative setting: a single center experience on 2,563 'near-misses' and adverse events.

BACKGROUND: The reduction of perioperative harm is a major priority of in-hospital health care and the reporting of incidents and their causes is an important source of information to improve perioperative patient safety. We explored the number, nature and causes of voluntarily reported perioperative incidents in order to highlight the areas where further efforts are required to improve patient safety. METHODS: Data from the Hospital Incident Management System (HIMS), entered in the period from July 2009 to July 2012, were analyzed in a Dutch university hospital. Employees in the perioperatve field filled out a semi-structured digital form of the reporting system. The risk classification of the reported adverse events and 'near misses' was based on the estimated patient consequences and the risk of recurrence, according to national guidelines. Predefined reported incident causes were categorized as human, organizational, technical and patient related. RESULTS: In total, 2,563 incidents (1,300 adverse events and 1,263 'near-miss' events) were reported during 67,360 operations. Reporters were anesthesia, operating room and recovery nurses (37%), ward nurses (31%), physicians (17%), administrative personnel (5%), others (6%) and unmentioned (3%). A total of 414 (16%) adverse events had patient consequences (which affected 0,6% of all surgery patients), estimated as catastrophic in 2, very serious in 34, serious in 105, and marginally serious in 273 cases. Shortcomings in communication was the most frequent reported type of incidents. Non-compliance with Standard Operating Procedures (SOPs: instructions, regulations, protocols and guidelines) was reported with 877 (34%) of incident reports. In total, 1,194 (27%) voluntarily reported causes were SOP-related, mainly human-based (79%) and partially organization-based (21%). SOP-related incidents were not associated with more patient consequences than other voluntarily reported incidents. Furthermore 'mistake or forgotten' (15%) and 'communication problems' (11%) were frequently reported causes of incidents. CONCLUSIONS: The analysis of voluntarily reported perioperative incidents identified an association between perioperative patient safety problems and human failure, such as SOP non-compliance, mistakes, forgetting, and shortcomings in communication. The data suggest that professionals themselves indicate that SOP compliance in combination with other human failures provide room for improvement.

[Fire by spontaneous combustion of oxygen cylinders]. / Spontaan ontbrandende zuurstofcilinders.

The use of medicinal oxygen can be dangerous. The spontaneous combustion of an oxygen cylinder was the cause of a fire in an operating theatre and an emergency medical service. The fire developed after turning on the gas main while the flow supply valve was already open. Not opening the pressure reduction valve while the oxygen flow supply valve is open can prevent this type of fire. Information from the contractor shows that the probability of such an incident is 1 in a million.

[The national Dutch Institute for Healthcare Improvement guidelines 'Preoperative trajectory': the essentials]. / De landelijke CBO-richtlijn 'Preoperatief traject': de essentie.

In view of the shortcomings of the organisation of the perioperative process that have been ascertained by the Dutch Health Inspectorate (IGZ), the Inspectorate has requested hospitals and care professionals to implement measures to improve this situation. In response to the IGZ's first report, the Dutch Institute for Healthcare Improvement (CBO) has developed the national, multiprofessional guidelines entitled 'Preoperative Trajectory' which were published in January 2010. Implementation of these guidelines should improve communication between professionals and lead to standardization and transparency of the preoperative patient care process, with uniform handovers and clear responsibilities. These guidelines are the first to provide recommendations at process of care level which are intended to increase patient safety and reduce the risk of damage to patients.