Patient Safety

This trial evaluates CITE, a retrieve-and-verify layer that audits an AI-generated care plan against a full-text evidence corpus and flags patient-specific codifiable safety hazards to the clinician. The co-primary outcomes are how accurately CITE flags these hazards (sensitivity and specificity versus blinded clinician adjudication) and its clinician alert burden and acceptance, compared with AI care plans using safety guardrails alone and with unassisted clinician care, in Medicaid primary care.

The goal of this observational study is to measure the cognitive load (mental effort) of anesthesia nurses during real surgical procedures at Hospital Clínic de Barcelona, Spain. The main questions it aims to answer are: * Does cognitive load vary across the three phases of anesthetic care (induction, maintenance, and emergence/recovery)? * Is cognitive load higher during general anesthesia than during spinal anesthesia with sedation? * How do surgical specialty and patient complexity relate to cognitive load? * How does monitor alarm perception relate to cognitive load during surgery? Participants (anesthesia nurses) will complete the NASA Task Load Index (NASA-TLX) questionnaire - a validated 6-item tool measuring mental effort - three times per surgical case: after induction or spinal block, during maintenance, and after patient awakening or sedation reversal. They will also answer 4 brief questions about alarm management at the end of each case. No changes are made to clinical care. Participation adds approximately 11 minutes per surgical case.

Unsafe patient care remains a major contributor to global morbidity and mortality. In surgical wards, postoperative patients are typically monitored intermittently using the National Early Warning Score (NEWS-2), leaving periods during which clinical deterioration may go undetected. Continuous vital sign monitoring (CVSM) using wearable sensors offers the potential for earlier identification of deterioration compared with intermittent assessments. CVSM was introduced in a hospital ward as part of a hospital-initiated pilot implementation and is used alongside standard monitoring with NEWS-2. The purpose of the study is to evaluate this implementation. This observational study uses a pragmatic, quasi-experimental, multi-method, longitudinal design. The overall aims of the study are to evaluate the impact of CVSM implementation on patient outcomes, to explore healthcare professionals' perceptions of patient safety culture, turnover intention and pleasure of work, and to describe their experiences with implementation.

Chemokeyp is a feasibility study testing a secure ED-Oncology interface for patients receiving chemotherapy who may present to unscheduled care with possible treatment-related complications. Participants are enrolled through Oncology and issued a medical-alert-style wristband with a QR code. If they attend the Emergency Department, staff can scan the QR code, access a generic study landing page, and, after SVUH authentication, complete a short structured checklist about possible serious adverse events such as infection, chest pain, vomiting, syncope, or other red-flag symptoms. The platform is designed as a secure research data-capture portal, not an electronic health record or clinical documentation system. It does not read from or write to the hospital EHR, does not provide clinical decision support, and does not change usual clinical care. Data entered by ED clinicians are limited to predefined structured fields for research and safety-signal feasibility purposes. The study will assess whether ED clinicians can complete the checklist in real time, whether the information can support earlier notification to the research/trial team, and whether this data accurately corresponds with verified serious adverse events. If feasible, Chemokeyp could help improve communication between Oncology, Emergency Medicine, and trial teams, supporting safer care for patients on chemotherapy and informing future development of ED-oncology digital safety tools.

Congenital syphilis in newborns requires intravenous antibiotic therapy, making reliable peripheral venous access essential. However, high rates of catheter failure and repeated punctures remain a significant clinical challenge. This randomized, controlled, parallel clinical trial aims to compare ultrasound-guided long peripheral intravenous catheters inserted by a specialized vascular access team with conventional short peripheral catheters inserted by neonatal nurses. A total of 104 newborns with congenital syphilis receiving intravenous penicillin will be randomly assigned to either group. The primary outcome is functional dwell time. Secondary outcomes include catheter failure, number of insertion attempts, first-attempt success, complications, and total number of devices required. The study hypothesizes that ultrasound-guided long peripheral catheters will improve vascular access outcomes, reduce complications, and minimize the need for repeated punctures.

Peripheral intravenous catheters (PIVCs) are widely used invasive devices in hospital settings and are associated with a broad range of complications, among which infiltration is one of the most common and clinically significant. Infiltration, defined as the leakage of intravenous fluids or medications into surrounding tissues, may result in local tissue damage, pain, infection, delayed treatment, and increased healthcare costs. Despite its high prevalence and impact on patient safety, early recognition and appropriate management of infiltration remain challenging, particularly among nursing students. Conventional educational approaches that rely predominantly on theoretical instruction may be insufficient to develop the clinical reasoning and decision-making skills required for timely identification and management of such complications. Therefore, there is a growing emphasis on the use of innovative, learner-centered educational strategies that promote active participation and experiential learning. Simulation-based education, including in situ simulation and standardized patient methodologies, has been shown to provide realistic, safe, and effective learning environments that enhance both technical and non-technical skills. In situ simulation enables training within real clinical settings using existing resources and team structures, while standardized patients facilitate the development of communication, clinical assessment, and decision-making competencies. This randomized controlled trial aims to evaluate the effectiveness of standardized patient and in situ simulation-based training, compared with traditional teaching methods, in improving nursing students' ability to recognize PIVC-related infiltration and enhance their clinical decision-making skills. Secondary outcomes include learning satisfaction and self-confidence. By integrating evidence-based simulation approaches into nursing education, this study seeks to strengthen clinical competence and contribute to improved patient safety outcomes.

This single-center, prospective, single-arm pilot study will evaluate a simulation-based interprofessional education program for early-career operating room team members at Yongin Severance Hospital. Participants will include postgraduate year 1-2 surgical residents, newly appointed anesthesia nurse practitioners, and newly appointed operating room nurses. Participants will complete two simulation-based interprofessional education sessions, each including scenario-based team training and structured debriefing. Teamwork self-efficacy and readiness for interprofessional learning will be assessed before and after the educational intervention. The study will also assess program completion as a feasibility outcome. Optional semi-structured interviews may be conducted to explore participants' perceptions of the program and suggestions for improvement.

Introduction: Patient safety issues, such as medication errors, healthcare-associated infections, unsafe surgical procedures, and diagnostic errors, can negatively impact the quality of healthcare and patient outcomes due to preventable risks. There is a need for innovative, interactive educational approaches to ensure the lasting acquisition of patient safety competencies in nursing students and to strengthen their transfer to the clinical environment. Aim: This study aims to evaluate the effect of gamified metaverse-based training on patient safety competencies in nursing students and to assess student opinions regarding metaverse-based training. Method: The research will be conducted using a mixed-methods design. The quantitative phase will be an experimental design including intervention and control groups, pre-test-post-test, and a one-month follow-up (retention test). The research will be conducted between February 2026 and May 2026 with second-year students studying in the Spring semester of 2025-2026 at Başkent University Nursing Department in Ankara. According to G\*Power calculations, a minimum sample size of 52 was found; considering a possible 10% loss, the total sample size was planned as 60 students (intervention=30, control=30). All participants will take the Patient Safety Knowledge Level Test (pre-test) and the Patient Safety Competency Self-Assessment Tool before the training. This will be followed by 2 hours of traditional theoretical training on patient safety; the intervention group will also receive gamified metaverse-based training via Spatial.io for two weeks. Post-tests will be administered after the training and one month later. Data collection tools include the Demographic Information Form, the Patient Safety Knowledge Level Test, the Patient Safety Competency Self-Assessment Tool (PSCS), and focus group interviews to be conducted in the intervention group. Quantitative data will be analyzed through within-group and between-group comparisons; qualitative data will be analyzed using thematic analysis, and the findings will be interpreted holistically. Findings (Expected): Gamified metaverse-based training is expected to provide a greater increase in mean scores on the Patient Safety Knowledge Level Test (PSL) and total and sub-dimension scores (knowledge-skills-attitudes) of nursing students compared to the control group, and to support the retention of these results. Conclusion: This study is expected to generate evidence regarding the effectiveness of gamified metaverse-based training in improving patient safety competencies in nursing education and to contribute to the structuring of patient safety training in a more integrated, student-centered, and sustainable manner.

Introduction: Falls are the most frequently reported and preventable type of safety incident. Patient falls are the most common adverse events in hospitals. This situation impacts clinical outcomes and increases the financial burden on healthcare systems. Simulation is an important component of nursing education because it enhances patient care and ensures patient safety. Objective: To comparatively examine the effect of standard patient-based and web-based simulation methods, implemented in addition to the same theoretical education provided to nursing students, on students' knowledge levels regarding fall risk assessment and their fall risk assessment skills in clinical practice. Materials and Methods: The study was conducted during the spring semester of the 2025-2026 academic year with first-year students in the Department of Nursing at Aydın Adnan Menderes University as part of the Fundamentals of Nursing course. All participating students will complete theoretical classes in the classroom and practical sessions in the laboratory. The study using standard patient and web-based simulation applications will be conducted in the simulation laboratory of the Faculty of Nursing at Aydın Adnan Menderes University. Research data will be collected using the "Individual Information Form," the "Fall Knowledge Test for Preventing Patient Falls" prepared in accordance with the literature, and the "Fall Risk Assessment Skills Rubric." Research data will be collected over a 4-month period (February 9 - June 9, 2026). A written permission letter will be obtained from the institution to conduct the study. Participants will be provided with detailed information about the study, and both verbal and written consent will be obtained. For numerically measured data, a normal distribution analysis will be performed; based on the results of this analysis, "Pearson Chi-square" and "t-tests" will be used for variables showing a normal distribution. Findings: The research findings will be presented based on the analyses conducted. Conclusion: The results will be presented based on the research findings, and recommendations will be made accordingly.

This study will evaluate if an intervention using academic detailing and audit and feedback impacts the specific pacemaker or implantable cardioverter-defibrillator (ICD) lead models implanted in Veterans.

Hospitals ineffectively examine the safety of their processes by relying on voluntary incident reporting (VIR) by clinical staff who are overworked and afraid to report. VIR captures only 1-10% of events, excludes patients and families, and underdetects events in vulnerable groups like patients with language barriers. Patients and families are vigilant partners in care who are adept at identifying errors and AEs. Failing to actively include patients and families in safety reporting and instead relying on flawed VIR presents an important missed opportunity to improve safety. To improve hospital safety, there is a critical need to coproduce (create in partnership with families) effective systems to identify uncaptured errors. Without this information, hospitals are impeded in their ability to improve patient safety. In partnership with diverse families, nurses, physicians, and hospital leaders, investigators created a multicomponent communication intervention to engage families of hospitalized children in safety reporting. The intervention includes 3 elements: (1) a multilingual mobile (email, text, and QR-code) reporting tool prompting families to share concerns and suggestions about safety, (2) family/staff education, and (3) a process for sharing family reports with the unit and hospital so systemic issues can be addressed.

This randomized controlled study will evaluate the effectiveness of an online Watch-Summarize-Question-Ask (WSQA) learning method on nursing students' knowledge, skills, attitudes, and behaviors related to patient fall prevention and management. Sixty-six nursing students will be randomly assigned to intervention and control groups. Both groups will receive standard patient safety education, while the intervention group will additionally participate in an online, evidence-based fall prevention training program structured according to the WSQA method, including video-based learning, summarization, question generation, and interactive discussions. Outcomes will be assessed using validated instruments measuring fall management knowledge, self-efficacy, attitudes toward fall prevention, care planning performance, and student satisfaction. The study aims to determine the effectiveness of an innovative educational approach to improve fall prevention competencies and enhance the quality and safety of nursing care.

The most fundamental principle of any healthcare service is "First, do no harm." No one should be harmed in healthcare services. Falls are the most frequently reported and preventable incident among all safety incidents in the hospital environment. However, falls are the most frequently reported incident among all safety incidents. Patient falls are the most common adverse events in hospitals. Patient falls in hospitals cause physiological and psychological harm to patients, affect the timeliness, effectiveness, and efficiency of care, and lead to increases in hospital costs and length of stay. Therefore, preventing falls, which have serious consequences, is of vital importance in terms of patient safety and healthcare quality. Nurses are a group that can sensitively identify and manage issues related to patient safety. Therefore, it is important to identify and reduce the underlying risk factors for falls in patients and to provide appropriate nursing interventions to prevent secondary injuries in patients who have fallen. Simulation is an important part of nursing education because it improves patient care and ensures patient safety. Simulation-based learning provides students with realistic clinical situations, allowing them to practice clinical skills in a safe environment. This enables students to develop their clinical skills, communication, decision-making, and self-efficacy in a risk-free, safe, and structured environment, representing a contemporary teaching approach. Teaching safe patient care during nursing students' education is one of the most fundamental elements of nursing education. Inadequate nursing knowledge and attitudes increase the risk of falls among patients receiving care. Students with insufficient clinical experience are at high risk of making undesirable errors in patient care. It is important to increase nursing students' knowledge and attitudes regarding falls during their education. The standard patient and web-based simulation application offers the closest experience to real clinical situations, providing students with significant potential to become aware of falls they may encounter in practice and prevent potential errors. The increasing importance given to patient safety due to the rising number of fall cases supports the necessity of this research. The aim of this study is to evaluate the effect of standard patient and web-based simulation methods on nursing students' knowledge and attitudes regarding falls.

As the professional group that has the most frequent contact with patients, nurses are critical to the sustainability of safe care. Literature demonstrates that nursing practice is prone to error due to heavy workloads, time pressures, complex clinical tasks, inadequate rest, inappropriate working conditions, and the physiological strain of demanding shifts. When these conditions strain both physical and cognitive resources, the risk of errors during treatment administration increases. Medical errors remain one of the most devastating realities of healthcare. Data from the World Health Organization reveals the significant morbidity and mortality caused by errors on a global scale. Numerous studies have demonstrated that student nurses have a significant rate of errors, and those with limited clinical experience are particularly at risk in fundamental areas such as medication administration, asepsis, and patient identification. Increasing patient numbers, short stays, rapid turnover, and the intense pace of clinics negatively impact student nurses' ability to provide safe care, prompting both educators and students to seek stronger pedagogical solutions. This is where simulation-based training comes into play. Simulation is emerging as a contemporary teaching approach that enables students to develop their clinical skills, communication, decision-making, and self-efficacy in a risk-free, safe, and structured environment. It is increasingly being used because it supports knowledge and skill transfer, reduces fear and anxiety, strengthens self-confidence, and provides the opportunity to experience errors. In-situ simulation and standardized patient practice offer strong potential for reducing students' error proneness by providing an experience closest to real-world clinical situations. However, the lack of a study in the literature examining the effects of these two methods, particularly on the medical error proneness and attitudes of final-year nursing students, is a significant gap. This study aims to strengthen a critical area of nursing education. The aim is to evaluate the impact of in-situ simulation and standardized patient practice on final-year nursing students' medical error proneness and attitudes toward medical errors and to reveal how they transform students' competencies in providing safe care.

The "OR Black box", an inclusive multiport data capturing system has been developed and successfully used for detailed analysis of laparoscopic surgical procedures. A pilot study has shown that this system can be successfully installed in the hybrid room at Ghent University Hospital and used for detailed analysis of intra-operative errors and radiation safety issues in endovascular procedures. Secondary analysis of pilot study data via direct video coding assessed the relationship between leadership style of the surgeon and team behavior and possible fluctuations during surgery. This novel approach allows a prospective objective assessment of human and environmental factors as well as measurement of errors, events and outcomes. In this study, the aim is to use the acquired knowledge to characterize a chain of events, identify high-risk interventions and identify areas for improvement, both on an organizational, team or individual level. Hypothesis: non-technical skills, environmental factors and teamwork in the hybrid room correlate with surgical technical performance and error rates. Furthermore, we hypothesize that incidents and adverse events can be tracked to a chain of errors that is influenced by technical and non-technical skills as well as environmental factors.

Introduction: Telenursing encompasses Nursing Consultation, Interconsultation, Consulting, Monitoring, Health Education and Reception of Spontaneous Demand mediated by Information and Communication Technology. Objective: To perform a cost-effectiveness analysis of telenursing in the immediate preoperative period of adult patients undergoing elective surgeries in a university hospital of the SUS. Materials and method: Cost-effectiveness analysis nested in a clinical trial or empirical economic analysis of the piggyback evaluation type. Divided into 2 phases: a) Experimental research - randomized clinical trial to be carried out in a university hospital located in Rio de Janeiro and part of the SUS, with two parallel groups - intervention and control - with 1:1 allocation. The inclusion criteria will be adult patients, of both sexes, in the immediate preoperative period who are admitted on the day of elective surgery from their home. Patients who are hospitalized, patients in ophthalmology and obstetrics specialties, and those who will undergo examinations in the surgical center will be excluded. The sample size calculation was performed with a 95% confidence level and a sample loss of 5%, totaling 352 patients. The sampling will be random. Randomization and allocation concealment will be performed by the independent researcher. Patients in the GI will receive telenursing on the day before surgery with an anamnesis script for telenursing by the main researcher. On the day of surgery, all patients on the surgical map who came from their residence will be directed to the nursing assessment room where the auxiliary researcher will apply the in-person anamnesis script. The data will be processed by two independent researchers in an electronic spreadsheet and will be analyzed using descriptive and inferential statistics. The research will respect all legal and ethical frameworks necessary for its implementation; b) Prospective analysis of complete economic evaluation - in the piggyback evaluation modality - of the cost-effectiveness type. The effectiveness of telenursing will be verified by the outcome of surgical cancellation. A decision tree model will be used with a view to analyzing the SUS user at the local level (microcosting). The time horizon will be two days. The cost-effectiveness threshold will be 1 GDP per capita and the data analysis will include deterministic and probabilistic sensitivity. Expected results: It is expected to prove that telenursing can be a safe and efficient method for guiding patients before surgery, generating greater patient satisfaction, increasing access to information about health care for users through remote communication with nurses, reducing the waiting list by reducing surgical cancellations and possible incorporation of telenursing as a consolidated practice in the university hospital studied.

Many patients, doctors and others worry that tired doctors provide worse patient care, may not learn well and become burnt-out. In response to these concerns, some countries changed their laws to limit work-hours for doctors in training ('residents'). In Canada, most residents work six or seven 24-30h shifts each month. A recent Canadian report ordered by Health Canada said that making good decisions about resident work-hour rules was "significantly limited by quality evidence, especially evidence directly attributable to the Canadian context." Creating this evidence is the main goal of this research. The pilot study in 2 intensive care units(ICU) found that shorter shifts may be worse for patients, and for residents were more tiring than expected but improved wellbeing. Learning was not assessed. Previous studies on resident work-hours report similar findings: conflicting effects for patients, benefits for resident wellbeing, inconsistent and under-studied effects on learning. Overall, these results are not conclusive and confirm the need for a larger study. The current study will provide high-quality Canadian evidence. The investigators will compare two common ICU schedules used in Canada: resident shifts of 16h and 24h. ICU patients are very sick, there is little margin for error: they need doctors who know them well and are thinking clearly. The effects of each schedule on patients and residents will be measured. For patients, mortality rates and harm caused by care in ICU will be studied. For resident education, their learning about managing common illnesses in ICU, to do basic ICU procedures, and communicate with families will be studied. For resident wellbeing measures will include sleepiness, other fatigue symptoms, and burnout. Investigators will study both resident and patient outcomes so that Canadians can understand trade-offs linked to changing schedules. With this knowledge, Canadians can expect safer care for today's patients and better-trained doctors for the patients of tomorrow.

The primary objective of this project is to enhance understanding of intrapartum patient safety and person-centered care through the evaluation of an intervention designed to improve team communication and patient involvement during childbirth, thereby positively impacting maternal and infant health. Despite various efforts to improve safety in intrapartum care, women and their infants are still harmed. Most adverse events within intrapartum care stem from communication and teamwork failures. Despite national and international recommendations, few interventions target patient safety by incorporating person-centered care. This project will investigate the effectiveness and implementation of the TeamBirth care process developed by Ariadne Labs Boston, U.S. to improve communication and teamwork among caregivers and women during childbirth. The Swedish version of this care process (TeamBirth-SWE) was adapted, tested, and piloted at Karolinska University Hospital during 2021. Hypothesis: We hypothesize that the TeamBirth-SWE intervention will have a positive impact on interprofessional teamwork, communication, information sharing, patient involvement, and shared decision-making during labor and birth. These improvements are expected to result in improved maternal and infant outcomes, process measures i.e., patient safety climate, interprofessional collaboration, and improved patient reported measures such as patient involvement, shared-decision-making, and satisfaction with care.

This study, titled "Automated Indicator Feedback for Improving the Quality of Discharge Letters: A Cluster-Randomized Controlled Trial" (FIAQ-LS), aims to evaluate whether continuous real-time feedback to hospital teams can improve the quality of discharge letters. Discharge letters are critical for ensuring continuity of care and reducing adverse events by providing detailed information about a patient's hospital stay to both the patient and their primary care physician. The study will be conducted at Grenoble Alpes University Hospital and involve 40 hospital services across three campuses. The trial design includes two parallel arms: an intervention group receiving monthly performance feedback through automated dashboards and a control group with no additional intervention. Services are randomized into these groups using a stratified cluster approach. The primary objective is to assess whether this intervention increases the proportion of discharge letters validated on the day of discharge compared to usual care. Secondary objectives include evaluating patient satisfaction, rates of unplanned 30-day readmissions, and completeness of discharge letter content. The study will include data from approximately 132,000 patient stays over two phases: a pre-implementation observational period (12 months) and an intervention phase (12 months). All data will be collected and analyzed anonymously, with findings expected to inform the broader implementation of quality improvement strategies in French hospitals.

The concept of patient safety first emerged more than two decades ago in research by practitioners applying different approaches to improve care in the areas they work in. The main goal in patient safety is to prevent mistakes while providing service, to protect patients from possible harm and to minimize the possibility of making mistakes. For this reason, patient safety is one of the indispensable parts of nursing education. The planned research will be carried out in order to increase the patient safety escape room design and the current knowledge level of student nurses and team cooperation on this subject. The research will be carried out with the first year students of the Faculty of Health Sciences, Nursing Department of a state university, in an experimental design with pre-test and post-test. The data of the research will be collected with the "General Information Questionnaire", "Patient Safety Knowledge Test", "Collaboration Scale" and "Gamy Experience for Gamification Scale". It is planned to carry out the study with 60 students. Control Group=30, Experiment Group=30. After the subject of patient safety is explained in the Nursing Fundamentals course, the students who agree to participate in the study will be randomly divided into experimental and control groups. Patient safety practices will be explained to the control and experimental group students with the demonstration method in the laboratory environment after the lesson. Experimental group students will be taken to patient safety escape rooms prepared by the researcher. Students will be taken to escape rooms in groups of 5 and will be expected to perform the targeted tasks. After the lab and escape room activity, students will fill in the knowledge test and scales again. Since there is a limited number of studies in the literature on the knowledge levels of nursing students on patient safety and team collaboration, and there is no study in which escape room design is used in the field of nursing in Turkey, the research is important in terms of filling this gap in the literature.