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Clinical Research Directory

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28 clinical studies listed.

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Patient Safety

Tundra lists 28 Patient Safety clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.

This data is also available as a public JSON API. AI systems and LLMs are encouraged to use it for structured queries.

RECRUITING

NCT07367906

Digital Microlearning and Patient Safety in Nursing Students

This randomized controlled study aims to evaluate the effect of a patient safety-focused digital microlearning program on nursing students before they begin surgical clinical practice. Nursing students often face challenges related to patient safety and clinical decision-making during the transition from classroom learning to clinical settings. This study will examine whether short, structured digital learning modules can improve patient safety awareness, recognition of clinical errors, and decision-making skills. Second-year undergraduate nursing students will be randomly assigned to either a digital microlearning intervention group or a control group receiving standard education. Outcomes will be measured before the intervention, immediately after the intervention, and during the first week of clinical practice.

Gender: All

Ages: 18 Years - Any

Updated: 2026-04-09

1 state

Medical Education
Patient Safety
NOT YET RECRUITING

NCT07514247

Standardized Patient and In Situ Simulation for IV Infiltration Recognition

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.

Gender: All

Ages: 18 Years - 23 Years

Updated: 2026-04-07

Patient Safety
Peripheral Intravenous Catheter-Related İnfiltration
NOT YET RECRUITING

NCT05062434

An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans

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.

Gender: All

Updated: 2026-04-02

1 state

Patient Safety
RECRUITING

NCT05407129

Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences

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.

Gender: All

Updated: 2026-03-24

1 state

Family Reported Errors and Adverse Events
Health Disparities
Family Safety Reporting
+3
NOT YET RECRUITING

NCT07471737

Patient Safety and Medical Errors in Nursing Education: Learning by Doing and Experiencing With Simulated Patients

This research will be conducted with the aim of enabling first year nursing students to learn about patient safety and medical errors through simulated patient education. Students will participate in the theoretical and practical laboratory work of the Fundamentals of Nursing course during the spring semester of 2025-2026. The research will be implemented after the laboratory applications. This research will evaluate the impact of simulated patient education on the outcomes of first-year students' patient safety goals ('Correct identification of patients', 'Ensuring medication safety', 'Reducing the risk of healthcare-associated infections' and 'Reducing the risk of patient harm from falls'). The researchers have developed six scenarios related to patient safety and medical errors. The research will be conducted in a randomised controlled experimental design (n=62). First-year nursing students will be administered the Patient Safety Competency Self-Evaluation Scale (pre-test), the Medical Error Tendency Scale (pre-test), and a knowledge test (pre-test). Students will be randomised into experimental and control groups based on their knowledge test (pre-test) mean scores. After all students in the experimental and control groups have completed the educator-centred theoretical and laboratory applications, the study will proceed to the application phase. First, those in the experimental group will participate in scenario applications (first and second scenarios) to gain experience with simulated patients. The first scenario covers applications related to the objectives of 'correct identification of patients' and 'ensuring medication safety'. The second scenario covers applications related to the objectives of 'reducing the risks associated with falls' and 'reducing the risk of healthcare-associated infections'. One week after the simulation, the experimental group will undergo psychomotor skill assessment related to patient safety on a simulated patient, and the control group will undergo psychomotor skill assessment on a low-fidelity manikin using control ists (first skill assessment). Subsequently, all students will undergo the Patient Safety Competency Self-Evaluation Scale (post-test), the Medical Error Tendency Scale (post-test), and a knowledge test (post test). Six weeks later, psychomotor skill assessments (second skill assessment) using control lists, the Patient Safety Competency Self-Evaluation Scale (follow up-test), the Medical Error Tendency Scale (follow-up test), and the knowledge test (follow-up test) will be administered again using the same method. The third and fourth scenarios will be used in the first psychomotor skill assessment exam that the experimental and control groups will take. The third scenario includes skills related to the objectives of 'verifying patient identity' and 'ensuring medication safety'. The fourth scenario includes skills related to the objectives of 'reducing the risk of healthcare-associated infections' and 'reducing the risks associated with falls'. The fifth and sixth scenarios will be used in the second psychomotor skills assessment exam for the experimental and control groups. The fifth scenario includes skills related to the objectives of 'verifying patient identity' and 'ensuring medication safety'. The sixth scenario includes skills related to the objectives of 'reducing the risk of healthcare-associated infections' and 'reducing the risks associated with falls'.

Gender: All

Updated: 2026-03-19

Simulation Training
Patient Safety
Medical Errors
+1
RECRUITING

NCT07449533

Smartphone Use in Healthcare Settings Among Nurses

The primary purpose of this study is to explore the impact of using smartphones and instant messaging applications among nurses in clinical settings. The study focuses on how these digital tools facilitate "instant action" and rapid communication regarding patient care. By analyzing the nature and speed of messages exchanged, the research aims to to assess smartphone use and its impact on clinical practice among nurses in healthcare settings., reducing clinical response time, and minimizing potential medical errors in healthcare environments. Data is being collected from participants through an online questionnaire. Meeting will be done with potential participants at break time, and the form link will be shared with them through whats app if they agree to participate in this study. Two tools will be used to collect data in this study. to evaluate the effectiveness of this communication medium in promoting a safer environment for patients.

Gender: All

Ages: 18 Years - Any

Updated: 2026-03-04

Patient Safety
Clinical Communication
Nursing Care
+2
NOT YET RECRUITING

NCT07428772

Online Watch-Summarize-Question-Ask Method in Falls Education for Nursing Students

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.

Gender: All

Ages: 18 Years - Any

Updated: 2026-02-24

Education
Online Learning
Fall Prevention
+3
NOT YET RECRUITING

NCT07394907

The Effectiveness of Gamified Metaverse-Based Training on Patient Safety for Nursing Students

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.

Gender: All

Updated: 2026-02-06

1 state

Gamification
Nursing Education
Patient Safety
+1
NOT YET RECRUITING

NCT07391111

THE EFFECT OF STANDARD PATIENT AND WEB-BASED SIMULATION ON FALL KNOWLEDGE AND ATTITUDES AMONG NURSING STUDENTS

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.

Gender: All

Updated: 2026-02-05

Patient Safety
Fall
Simulation Edication
NOT YET RECRUITING

NCT07349355

Simulation Practices and Medical Error Tendencies in Nursing Students

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.

Gender: All

Updated: 2026-01-16

Patient Safety
RECRUITING

NCT04854278

Introduction of an Operating Room Black Box to Identify, Analyse and Prevent Errors in the Vascular Hybrid Room

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.

Gender: All

Ages: 18 Years - Any

Updated: 2025-12-22

1 state

Patient Safety
Endovascular Procedures
Quality Improvement
ENROLLING BY INVITATION

NCT06888297

RESCUE: European Certification for Second Victim Support

The "second victim" phenomenon affects healthcare professionals who experience highly stressful events in their daily practice, potentially compromising their well-being and patient safety. Despite the need for structured support interventions, many European institutions lack formal programs to address this issue. The RESCUE project responds to this need, building on the previous work of the ERNST Consortium (COST Action 19113). Its objective is to develop and validate two certification systems: one for second victim support interventions and another for training healthcare professionals as peer supporters. A mixed-methods approach will be used, incorporating expert consensus techniques (e.g., Delphi study and consensus conferences) and pilot studies in healthcare institutions across multiple European countries. The study aims to establish European certification standards for second victim support interventions, improving support for healthcare professionals, increasing resilience, and reducing the impact of adverse events on clinical performance.

Gender: All

Ages: 18 Years - Any

Updated: 2025-09-10

1 state

Second Victim Phenomenon
Occupational Stress
Healthcare Workforce Well-Being
+3
ACTIVE NOT RECRUITING

NCT06574906

Machine Learning Prediction of Parameters of Early Warning Scores in General Wards

In the event of illness or injury, patients are medically evaluated and initially treated in acute medical outpatient clinics, emergency rooms and surgeries. If medically indicated, care and treatment can also be provided in hospital. Depending on the severity of the illness and the main medical problem, this care is provided on hospital wards, which are primarily looked after by specific specialist disciplines and assigned to them in the form of clinical departments, for example. As part of the inpatient stay, treatment and care is usually provided through ward rounds by the medical staff. However, ward rounds are spot checks of individual measured values at predefined times. Qualified nursing staff carry out the agreed treatment plans and check the patient's general condition several times a day. In contrast to intensive medical monitoring, however, there is no continuous monitoring and therefore an aggravation of a patient's condition is not always immediately apparent. Furthermore, in addition to known complications of existing conditions, new or unexpected complications can also occur. Although non-intensive care monitoring is based on discontinuous monitoring, incidents and complications can sometimes be life-threatening, especially if there is no immediate response to a deterioration in the patient's condition. Even if there are early warning systems such as scores, their ability to react is limited, partly due to the frequency with which they are collected. In addition to patient-specific limitations of inpatient monitoring, such as patient cooperation in the sense of self-monitoring, medical limitations, such as the frequency of the survey, there are also economic limitations, such as the availability of staff who can be deployed for more frequent monitoring. Although there are telemedical approaches to monitoring, setting these up is often limited both economically and by the additional training required, for example. Even if threshold values are (or can be) defined for the measured data (vital signs, laboratory parameters, clinical impression and others), if these are exceeded or not reached, a consequence, e.g. a therapy step, can only be initiated retrospectively. In this situation, a pathophysiological change is already so far advanced that in many cases a compensation mechanism no longer functions adequately and turns into a decompensation situation. In this situation, the affected patients in a hospital ward are potentially in mortal danger. One way of averting the dangers described above could be to use a reduced combination of monitoring methods compared to intensive care monitoring. At the same time, the use of artificial intelligence enables the automated evaluation of the collected data and can thus lead to the prediction of changes in parameters, which enables early alerting, i.e. before the occurrence of pathophysiological decompensation.

Gender: All

Ages: 18 Years - Any

Updated: 2025-09-03

1 state

Patient Safety
ENROLLING BY INVITATION

NCT04571749

Handoffs and Transitions in Critical Care - Understanding Scalability

The investigators will leverage implementation science and engineering to adapt, implement, and rigorously evaluate tailored postoperative handoff protocols and implementation strategies. In doing so, the investigators will develop a vital understanding of the factors needed for successful and sustained use of evidence-based interventions in acute care. This knowledge will inform approaches to bridge the evidence-to-practice gap that prevents effective interventions from realizing the promise of improved patient outcomes in acute care settings.

Gender: All

Ages: 18 Years - Any

Updated: 2025-08-08

4 states

Patient Handoff
Healthcare Team
Communication
+2
NOT YET RECRUITING

NCT07068152

TELENURSING IN THE IMMEDIATE PREOPERATIVE PERIOD OF ELECTIVE SURGERIES

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.

Gender: All

Ages: 18 Years - Any

Updated: 2025-07-20

1 state

Preoperative Care
Telenursing
Patient Safety
+2
RECRUITING

NCT06089239

Choosing Wisely: De-implementing Fall Prevention Alarms in Hospitals

This is a Hybrid II de-implementation study to reduce use of fall prevention alarms in hospitals. The intervention consists of tailored, site-specific approaches for three core implementation strategies: education, audit/feedback and opinion leaders. Hospital units will be randomized to low-intensity or high-intensity coaching for the implementation of the tailored strategies.

Gender: All

Ages: 18 Years - Any

Updated: 2025-07-16

15 states

Accidental Fall
Patient Safety
Hospital Acquired Condition
+2
ACTIVE NOT RECRUITING

NCT06711484

Evaluation of the Efficiency of a Training Program Developed For Newly Graduate Nurses

Brief Summary: This research is a randomized, pre-test post-test control group, parallel group experimental study to evaluate the effectiveness of the language training program developed for newly graduated nurses. The study will be conducted with a total of 76 newly graduated nurses, 38 in the experimental group and 38 in the control group, at Etlik City Hospital Orthopedics-Neurology Hospital in Ankara. Participants will be informed about the study at the beginning of the study. Participants who agree to participate in the study and meet the eligibility criteria will be randomly assigned to groups by an independent statistician. The language training program will be applied to the experimental group, while no intervention will be made to the control group. The training program to be given to the experimental group will consist of a total of two days and four sessions (communication, speaking, patient safety, medical error), and each session will last 90 minutes. Data collection forms will be applied to the experimental and control groups before and after the training. Data collection forms include the descriptive characteristics form, working voice scale, effective communication skills scale, attitude scale in medical errors, and feedback about the language training program. Blinding of the raters will be applied to the participants to minimize bias. Data analysis will use statistical software that uses parametric tests for normally distributed data and nonparametric tests for non-normally distributed data.

Gender: All

Updated: 2025-06-03

1 state

Patient Safety
Nurse Training
Communication
RECRUITING

NCT06926504

TeamBirth-SWE - a Care Process to Improve Safe and Person-centered Intrapartum Care

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.

Gender: FEMALE

Ages: 15 Years - Any

Updated: 2025-04-13

5 states

Person Centered Care
Patient Safety
Patient Satisfaction
RECRUITING

NCT04176094

Intensive Care Unit Resident Scheduling Trial

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.

Gender: All

Ages: 18 Years - Any

Updated: 2025-04-11

1 state

Patient Safety
Well-being
Education
NOT YET RECRUITING

NCT06835153

Automatic Feedback Indicator to Enhance the Hospital Discharge Communication Between Acute Care and Primary 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.

Gender: All

Updated: 2025-02-19

Continuity of Care
Patient Safety
Hospital Discharge Communication Processes
+3
ENROLLING BY INVITATION

NCT06398860

A Structured Method for Systematic and Integrated Occupational Safety and Health and Patient Safety Management Systems

The evidence unequivocally supports the association between work environment and patient safety. The negative impact of working conditions on both employee health and quality of care highlights the potential benefits of integrating these areas. It is therefore suggested that integrated systematic occupational health and patient safety management are crucial in managing the challenges faced by healthcare services today. The project aims to assess the effectiveness and cost-effectiveness of a structured method for systematic and integrated occupational safety and health and patient safety management systems (SIOHPS). A process evaluation will be conducted alongside the main study to determine the intervention's specific outcomes and provide transferable guidance to a wider context. The intervention is designed to support both systematic occupational health and patient safety management systems using a Safety II-perspective. The intervention is comprised of several core components, including education to staff, support-functions and management, daily team reflections; as well as audit and feedback. A stepped wedge cluster-controlled design (SWD) will be used, with workplaces as clusters. The SWD will consist of three steps, with four clusters crossing over from the control to the intervention group at each step. All clusters will start as controls. At least twelve healthcare units with at least thirty employees per workplace from two different regions in Sweden will participate in the intervention. Workplaces that provide round-the-clock care are invited to participate in the study. Exclusion criteria are units with plans to implement any other occupational health and/or patient safety improvement work during the project period. At the individual level, inclusion criteria for employees include at least 50% of full-time work at the workplace. The SIOHPS project will contribute to the existing theory on safety culture interventions by considering the integration of these areas. The goal is to contribute to a safe environment for both employees and patients.

Gender: All

Ages: 18 Years - 70 Years

Updated: 2025-02-04

Sick Leave
Quality Of Care
Occupational Health
+7
ACTIVE NOT RECRUITING

NCT06762015

Nursing Practice Environment and Patient Safety in Primary Health Care

The goal of this study is to conduct an experimental, controlled, and randomized study, which will involve two data collection points - pre-intervention, post-intervention and a follow-up to asses the impact of the program. The study will be carried out with two groups - an intervention group and a control group, consisting of nurses interested in participating in the Positive Nursing Practice Environments Promotion Program (PAPEP), a multi-component intervention program aimed at promoting positive nursing practice environments. Participant allocation will be conducted randomly, using software to ensure stratified randomization of participants between the two groups.

Gender: All

Ages: 18 Years - Any

Updated: 2025-01-07

1 state

Healthy Work Environment
Patient Safety
Primary Health Care
ACTIVE NOT RECRUITING

NCT05958108

Effectivenness and Implementation of an Intervention to Improve Primary Care Patient Safety

Aims: To evaluate the effectiveness of SinergiAPS (a patient-centered audit and feedback intervention) in reducing avoidable hospital admission, and; to explore the factors that may affect its implementation. Design: 24-month, parallel, open-label, multicentre, pragmatic, hybrid type 1 randomized clinical trial. Setting, sample, and randomization: 118 primary healthcare centers from multiple regions in Spain will be randomly assigned (ratio 1:1) to two groups (control and intervention). The intervention group will receive two audits (baseline and intermediate at 12 months). The audits will consist of the administration of the PREOS-PC questionnaire (a measure of patient-reported patient safety) to a sample of around 100 patients per center. The intervention group will receive reports on the results of both audits, along with resources aimed at facilitating the design and implementation of safety improvement plans. The intervention will be deployed through the SinergiAPS web tool, developed and validated in previous projects. The control group will have access to the intervention after the end of the clinical trial (waitlist). Outcomes: Primary outcome: rate of avoidable hospitalizations (electronic health records). Secondary outcomes: patient-reported patient safety (PREOS-PC questionnaire); patient safety culture perceived by professionals (MOSPC questionnaire); adverse events experienced by healthcare professionals (ad hoc questionnaire); the number of safety improvement actions (ad hoc questionnaire). Outcome data will be collected at baseline and at 24 months follow-up. Implementation evaluation: Drawing on the CFIR model, we will collect and analyze qualitative (30 individual interviews, implementation logbooks) and quantitative (questionnaires for professionals from intervention centers, level of use of the SinergiAPS web tool) data to examine the implementation of the intervention in the Spanish primary healthcare centers.

Gender: All

Ages: 18 Years - Any

Updated: 2024-12-12

7 states

Patient Safety
RECRUITING

NCT06574867

Evaluation of the viQtor Monitoring Solution on Surgical Wards

The REQUEST study aims to evaluate the use of a new wireless monitoring device, called the viQtor solution, on a surgical ward in Catharina Hospital Eindhoven. This device continuously tracks vital signs, such as heart rate, breathing rate, and blood oxygen levels, in patients after surgery. The goal is to see if the viQtor solution can help detect health problems earlier and reduce the workload for nurses by minimizing the need for manual checks. The study will involve 500 patients and will take place over 7 months.

Gender: All

Ages: 18 Years - Any

Updated: 2024-11-01

1 state

Monitoring
Post-operative Monitoring
Patient Safety
+2