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BACKGROUND: Despite substantial efforts to reduce operating room (OR) turnover time (TOT), delays remain a frustration to physicians, staff, and hospital leadership. These efforts have employed many systems and human factor-based approaches with variable results. A deeper dive into methodologies and their applicability could lead to successful and sustained change. The aim of this study was to conduct a systematic review to evaluate relevant research focused on improving OR TOT and clearly defining measures of successful intervention. MATERIAL AND METHODS: A systematic review of OR TOT interventions implemented between 1980 through October 2022 was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology. Research databases included: 1) PubMed; 2) Web of Science; and 3) OVID Medline. RESULTS: A total of 38 articles were appropriate for analysis. Most employed a pre/post intervention approach (29, 76.3%), the remaining utilized a control/intervention approach. Nine intervention methods were identified: the majority included a process redesign bundle (24, 63%), followed by overlapping induction, dedicated unit/team/space feedback, financial incentives, team training, education, practice guidelines, and redefinition of roles/responsibilities. Studies were further categorized into one of two groups: (1) those that utilized predetermined interventions based on anecdotal experience or prior literature (18, 47.4%) and (2) those that conducted a prospective analysis on baseline data to inform intervention development (20, 52.6%). DISCUSSION: There are significant variability in the methodologies utilized to improve OR TOT; however, the most effective solutions involved process redesign bundles developed from a prospective investigation of the clinical work-system.
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Quirófanos , Humanos , Eficiencia Organizacional , Quirófanos/organización & administración , Mejoramiento de la Calidad , Factores de Tiempo , Flujo de TrabajoRESUMEN
BACKGROUND: Incident reports submitted during times of organizational stress may reveal unique insights. PURPOSE: To understand the insights conveyed in hospital incident reports about how work system factors affected medication safety during a coronavirus disease-2019 (COVID-19) surge. METHODS: We randomly selected 100 medication safety incident reports from an academic medical center (December 2020 to January 2021), identified near misses and errors, and classified contributing work system factors using the Human Factors Analysis and Classification System-Healthcare. RESULTS: Among 35 near misses/errors, incident reports described contributing factors (mean 1.3/report) involving skill-based errors (n = 20), communication (n = 8), and tools/technology (n = 4). Reporters linked 7 events to COVID-19. CONCLUSIONS: Skill-based errors were the most common contributing factors for medication safety events during a COVID-19 surge. Reporters rarely deemed events to be related to COVID-19, despite the tremendous strain of the surge on nurses. Future efforts to improve the utility of incident reports should emphasize the importance of describing work system factors.
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COVID-19 , Errores de Medicación , Humanos , Gestión de Riesgos , Hospitales , Centros Médicos Académicos , COVID-19/epidemiología , Errores Médicos , Seguridad del PacienteRESUMEN
BACKGROUND: Challenges associated with turnover time are magnified in robotic surgery. The introduction of advanced technology increases the complexity of an already intricate perioperative environment. We applied a human factors approach to develop systematic, data-driven interventions to reduce robotic surgery turnover time. METHODS: Researchers observed 40 robotic surgery turnovers at a tertiary hospital [20 pre-intervention (Jan 2018 to Apr 2018), 20 post-intervention (Jan 2019 to Jun 2019)]. Components of turnover time, including cleaning, instrument and room set-up, robot preparation, flow disruptions, and major delays, were documented and analyzed. Surveys and focus groups were used to investigate staff perceptions of robotic surgery turnover time. A multidisciplinary team of human factors experts and physicians developed targeted interventions. Pre- and post-intervention turnovers were compared. RESULTS: Median turnover time was 67 min (mean: 72, SD: 24) and 22 major delays were noted (1.1/case). The largest contributors were instrument setup (25.5 min) and cleaning (25 min). Interventions included an electronic dashboard for turnover time reporting, clear designation of roles and simultaneous completion of tasks, process standardization of operating room cleaning, and data transparency through monthly reporting. Post-intervention turnovers were significantly shorter (U = 57.5, p = .000) and ten major delays were noted. CONCLUSIONS: Human factors analysis generated interventions to improve turnover time. Significant improvements were seen post-intervention with a reduction in turnover time by a 26 min and decrease in major delays by over 50%. Future opportunities to intervene and further improve turnover time include targeting pre- and post-operative care phases.
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Quirófanos , Procedimientos Quirúrgicos Robotizados , Ergonomía , Humanos , Reorganización del Personal , Factores de TiempoRESUMEN
STUDY OBJECTIVE: This study aimed to apply a structured human factors analysis to understand conditions contributing to vaginal retained foreign objects (RFOs). DESIGN: All potential vaginal RFO events from January 1, 2000, to May 21, 2019, were analyzed by trained human factors researchers. Each narrative was reviewed to identify contributing factors, classified using the Human Factors Analysis and Classification System for Healthcare. SETTING: An 890-bed, academic medical center in Southern California. PATIENTS: Patients who underwent a vaginal procedure in which a vaginal RFO-related event occurred were included in this study. However, no patient information was included, and only the relevant details from their procedures were included. INTERVENTIONS: No interventions were developed or implemented. MEASUREMENTS AND MAIN RESULTS: Over the 19-year period, 45 events were reported. The most common items were vaginal packing and vaginal sponges (53.33%). Less frequently retained items involved broken instruments (20.20%). Most cases were laparoscopic hysterectomies or vaginal deliveries. Based on the Human Factors Analysis and Classification System, 75 contributing factors were identified, consisting primarily of preconditions for unsafe acts (communication challenges, coordination breakdowns and issues with the design of tools/technology) and unsafe acts (errors). CONCLUSION: Although rare, vaginal RFOs do occur. The top 2 contributing factors were skill-based errors and communication breakdowns. Both types of errors can be addressed and improved with human factors interventions, including simulation, teamwork training, and streamlining workflow to reduce the opportunity for errors.
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Cuerpos Extraños , Femenino , Cuerpos Extraños/etiología , Cuerpos Extraños/cirugía , Humanos , Errores Médicos , Vagina/cirugíaRESUMEN
This prospective investigation describes the process of designing a targeted, data-driven team training aimed at reducing identified process inefficiencies or flow disruptions (FDs) that threaten the optimal delivery of trauma care. Trained researchers observed and classified FDs during 34 trauma cases in a Level II trauma center. Multidisciplinary trauma personnel generated interventions to identified issues using the human factors intervention matrix (HFIX). This article focuses on one intervention: a formal trauma nurse training program centered around leadership, teamwork, and communication. The training was well perceived and was found to have a significant impact on participant knowledge of course content; t (65) = -13.92, p ≤ .01. By using hospital-specific data to drive intervention development from multidisciplinary team members, it is possible to develop effective solutions aimed at addressing individual threats.
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Competencia Clínica , Incidentes con Víctimas en Masa , Grupo de Atención al Paciente , Simulación de Paciente , Educación Continua en Enfermería , Florida , Humanos , Estudios Prospectivos , Centros TraumatológicosRESUMEN
BACKGROUND: The utilization of robot-assisted approaches to surgery has increased significantly over the last two decades. This has introduced novel complexities into the operating room environment, requiring management of new challenges and workflow adaptation. This study aimed to analyze challenges in the surgical setup for complex upper gastrointestinal robot-assisted surgery (UGI-RAS) and identify opportunities for solutions. METHODS: Direct observations of surgical setup processes for UGI-RAS were performed by a trained Human Factors researcher at a non-profit academic medical center in Southern California. Setup tasks were subdivided into five phases: (1) before wheels-in; (2) patient transfer and anesthesia induction; (3) patient preparation; (4) surgery preparation; and (5) robot docking. Start/end times for each phase/task were documented along with workflow disruption (FD) narratives and timestamps. Setup tasks and FDs were analyzed using descriptive statistics. RESULTS: Twenty UGI-RAS setup procedures were observed between May-November 2023: sleeve gastrectomy +/- hiatal hernia repair (n = 9, 45.00%); para-esophageal hernia repair +/- fundoplication (n = 8, 40.00%); revision to Roux-en-Y gastric bypass (n = 2, 10.00%); and gastric band removal (n = 1, 5.00%). Frequent FDs included planning breakdowns (n = 20, 29.85%), equipment/supply management (n = 17, 25.37%), patient care coordination (n = 8, 11.94%), and equipment challenges (n = 8, 11.94%). Eleven of 20 observations were first-start cases, of which 10 experienced delayed starts. DISCUSSION: Interventions aimed at improving workflows during UGI-RAS setup include performing pre-operative team huddles and conducting trainings aimed at team coordination and equipment challenges. These solutions could result in improved teamwork, efficiency, and communication while reducing case start delays and turnover time.
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Procedimientos Quirúrgicos Robotizados , Humanos , Flujo de Trabajo , Procedimientos Quirúrgicos del Sistema Digestivo/métodos , Procedimientos Quirúrgicos del Sistema Digestivo/instrumentación , Procedimientos Quirúrgicos Mínimamente Invasivos/métodosRESUMEN
It is unknown whether the July Effect (a theory that medical errors and organizational inefficiencies increase during the influx of new surgical residents) exists in urologic robotic-assisted surgery. The aim of this study was to investigate the impact of urology resident training on robotic operative times at the beginning of the academic year. A retrospective chart review was conducted for urologic robotic surgeries performed at a single institution between 2008 and 2019. Univariate and multivariate mix model analyses were performed to determine the association between operative time and patient age, estimated blood loss, case complexity, robotic surgical system (Si or Xi), and time of the academic year. Differences in surgery time and non-surgery time were assessed with/without resident presence. Operative time intervals were included in the analysis. Resident presence correlated with increased surgery time (38.6 min (p < 0.001)) and decreased non-surgery time (4.6 min (p < 0.001)). Surgery time involving residents decreased by 8.7 min after 4 months into the academic year (July-October), and by an additional 5.1 min after the next 4 months (p = 0.027, < 0.001). When compared across case types stratified by complexity, surgery time for cases with residents significantly varied. Cases without residents did not demonstrate such variability. Resident presence was associated with prolonged surgery time, with the largest effect occurring in the first 4 months and shortening later in the year. However, resident presence was associated with significantly reduced non-surgery time. These results help to understand how new trainees impact operating room times.
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Internado y Residencia , Tempo Operativo , Procedimientos Quirúrgicos Robotizados , Procedimientos Quirúrgicos Urológicos , Urología , Internado y Residencia/estadística & datos numéricos , Internado y Residencia/métodos , Procedimientos Quirúrgicos Robotizados/educación , Procedimientos Quirúrgicos Robotizados/métodos , Procedimientos Quirúrgicos Robotizados/estadística & datos numéricos , Humanos , Estudios Retrospectivos , Procedimientos Quirúrgicos Urológicos/educación , Urología/educación , Femenino , Masculino , Persona de Mediana Edad , Errores Médicos/prevención & control , Errores Médicos/estadística & datos numéricos , Factores de TiempoRESUMEN
BACKGROUND: Current approaches to assessing workload in robotic-assisted surgery (RAS) focus on surgeons and lack real-world data. Understanding how workload varies by role and specialty aids in identifying effective ways to optimize workload. METHODS: SURG-TLX surveys with six domains of workload were administered to surgical staff at three sites. Staff reported workload perceptions for each domain on a 20-point Likert scale, and aggregate scores were determined per participant. RESULTS: 188 questionnaires were obtained across 90 RAS procedures. Significantly higher aggregate scores were reported for gynecology (Mdn â= â30.00) (p â= â0.034) and urology (Mdn â= â36.50) (p â= â0.006) than for general (Mdn â= â25.00). Surgeons reported significantly higher scores for task complexity (Mdn â= â8.00) than both technicians (Mdn â= â5.00) (p â= â0.007), and nurses (Mdn â= â5.00). CONCLUSIONS: Staff reported significantly higher workload during urology and gynecology procedures, and experienced significant differences in domain workload by role and specialty, elucidating the need for tailored workload interventions.
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Ginecología , Procedimientos Quirúrgicos Robotizados , Cirujanos , Urología , Humanos , Carga de TrabajoRESUMEN
PURPOSE: Bariatric surgery is an effective and durable treatment for weight loss for patients with extreme obesity. Although traditionally approached laparoscopically, robotic bariatric surgery (RBS) has unique benefits for both surgeons and patients. Nonetheless, the technological complexity of robotic surgery presents new challenges for OR teams and the wider clinical system. Further assessment of the role of RBS in delivering quality care for patients with obesity is necessary and can be done through a human factors approach. This observational study sought to investigate the impact of RBS on the surgical work system via the study of flow disruptions (FDs), or deviations from the natural workflow progression. MATERIALS AND METHODS: RBS procedures were observed between October 2019 and March 2022. FDs were recorded in real time and subsequently classified into one of nine work system categories. Coordination FDs were further classified into additional sub-categories. RESULTS: Twenty-nine RBS procedures were observed at three sites. An average FD rate of 25.05 (CI = ± 2.77) was observed overall. FDs were highest between insufflation and robot docking (M = 29.37, CI = ± 4.01) and between patient closing and wheels out (M = 30.00, CI = ± 6.03). FD rates due to coordination issues were highest overall, occurring once every 4 min during docking (M = 14.28, CI = ± 3.11). CONCLUSION: FDs occur roughly once every 2.4 min and happen most frequently during the final patient transfer and robot docking phases of RBS. Coordination challenges associated with waiting for staff/instruments not readily available and readjusting equipment contributed most to these disruptions.
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Cirugía Bariátrica , Obesidad Mórbida , Procedimientos Quirúrgicos Robotizados , Humanos , Procedimientos Quirúrgicos Robotizados/métodos , Flujo de Trabajo , Obesidad Mórbida/cirugía , ObesidadRESUMEN
BACKGROUND: Intraoperative death (ID) is rare, the incidence remains challenging to quantify and learning opportunities are limited. We aimed to better define the demographics of ID by reviewing the longest single-site series. METHODS: Retrospective chart reviews, including a review of contemporaneous incident reports, were performed on all ID between March 2010 to August 2022 at an academic medical center. RESULTS: Over 12 years, 154 IDs occurred (â¼13/year, average age: 54.3 years, male: 60%). Most occurred during emergency procedures (n = 115, 74.7%), 39 (25.3%) during elective procedures. Incident reports were submitted in 129 cases (84%). 21 (16.3%) reports cited 28 contributing factors including challenges with coordination (n = 8, 28.6%), skill-based errors (n = 7, 25.0%), and environmental factors (n = 3, 10.7%). CONCLUSIONS: Most deaths occurred in patients admitted from the ER with general surgical problems. Despite expectations for incident reporting, few provided actionable information on ergonomic factors which might help identify improvement opportunities.
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Centros Médicos Académicos , Gestión de Riesgos , Humanos , Masculino , Persona de Mediana Edad , Hospitalización , Incidencia , Errores Médicos , Estudios Retrospectivos , FemeninoRESUMEN
Background: Incident reporting is widely used in hospitals to improve patient safety, but current reporting systems do not function optimally. The utility of incident reports is limited because hospital staff may not know what to report, may fear retaliation, and may doubt whether administrators will review reports and respond effectively. Methods: This is a clustered randomized controlled trial of the Safety Action Feedback and Engagement (SAFE) Loop, an intervention designed to transform hospital incident reporting systems into effective tools for improving patient safety. The SAFE Loop has six key attributes: obtaining nurses' input about which safety problems to prioritize on their unit; focusing on learning about selected high-priority events; training nurses to write more informative event reports; prompting nurses to report high-priority events; integrating information about events from multiple sources; and providing feedback to nurses on findings and mitigation plans. The study will focus on medication errors and randomize 20 nursing units at a large academic/community hospital in Los Angeles. Outcomes include: (1) incident reporting practices (rates of high-priority reports, contributing factors described in reports), (2) nurses' attitudes toward incident reporting, and (3) rates of high-priority events. Quantitative analyses will compare changes in outcomes pre- and post-implementation between the intervention and control nursing units, and qualitative analyses will explore nurses' experiences with implementation. Conclusion: If effective, SAFE Loop will have several benefits: increasing nurses' engagement with reporting, producing more informative reports, enabling safety leaders to understand problems, designing system-based solutions more effectively, and lowering rates of high-priority patient safety events.
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ABSTRACT: This article reviews several key aspects of the Theory of Active and Latent Failures, typically referred to as the Swiss cheese model of human error and accident causation. Although the Swiss cheese model has become well known in most safety circles, there are several aspects of its underlying theory that are often misunderstood. Some authors have dismissed the Swiss cheese model as an oversimplification of how accidents occur, whereas others have attempted to modify the model to make it better equipped to deal with the complexity of human error in health care. This narrative review aims to provide readers with a better understanding and greater appreciation of the Theory of Active and Latent Failures upon which the Swiss cheese model is based. The goal is to help patient safety professionals fully leverage the model and its associated tools when performing a root cause analysis as well as other patient safety activities.
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Seguridad del Paciente , Análisis de Causa Raíz , Atención a la Salud , HumanosRESUMEN
This systematic review provides information on the methodologies, measurements and classification systems used in observational studies of flow disruptions in clinical environments. The PRISMA methodology was applied and authors searched two databases (PubMed and Web of Science) for studies meeting the following inclusion criteria: (a) were conducted in a healthcare setting, (b) explored systems-factors leading to deviations in care processes, (c) were prospective and observational, (d) classified observations, and (e) were original research studies published in peer-reviewed journals. Thirty studies were analyzed and a variety of methods were identified for observer training, data collection and observation classification. Although primarily applied in surgery, comparable research has been successfully conducted in other venues such as trauma care, and delivery rooms. The findings of this review were synthesized into a framework of considerations for conducting rigorous methodological studies aimed at understanding clinical systems.
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Atención a la Salud , Recolección de Datos , Humanos , Estudios ProspectivosRESUMEN
INTRODUCTION: There is ongoing interest in the development of technical and nontechnical skills in healthcare to improve safety and efficiency; however, barriers to developing and delivering related training programs make them difficult to implement. Unique approaches to training such as "serious games" may offer ways to motivate teams, reinforce skill acquisition, and promote teamwork. Given increased challenges to teamwork in robotic-assisted surgery (RAS), researchers aimed to develop the "RAS Olympics," a game-based educational competition to improve skills needed to successfully perform RAS. METHODS: This pilot study was conducted at an academic medical center in Southern California. Robotic-assisted surgery staff were invited to participate in the "RAS Olympics" to develop their skills and identify opportunities to improve processes. Impact of the activity was assessed using surveys and debriefs. RESULTS: Sixteen operating room team members participated and reacted favorably toward the RAS-Olympics (average score, 4.5/5). They enjoyed the activity, would recommend all staff participate, felt that it was relevant to their work, and believed that they practiced and learned new techniques that would improve their practice. Confidence in skills remained unchanged. Participants preferred the RAS Olympics to traditional training because it provided an interactive learning environment. CONCLUSIONS: The successful implementation of the RAS Olympics provided insight into new opportunities to engage surgical staff members while also training technical and nontechnical skills. Furthermore, this shared experience allowed surgical staff members to gain a greater appreciation for their teammates and an understanding of the current challenges and methods to improve teamwork and communication while promoting safety and efficiency in RAS.
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Procedimientos Quirúrgicos Robotizados , Entrenamiento Simulado , Competencia Clínica , Humanos , Grupo de Atención al Paciente , Proyectos Piloto , Entrenamiento Simulado/métodosRESUMEN
The RN circulator role includes maintaining situational awareness and mitigating risks to patient safety in the OR. Flow disruptions-deviations that threaten the safe and efficient flow of surgery-may contribute to the occurrence of errors and negatively affect safety for patients and health care providers. We used an existing data set to explore the effects of flow disruptions on the RN circulator. To create the data set, doctoral-level human factors students observed 24 cardiac surgery procedures and recorded the types and durations of disruptions. We used a human factors taxonomy to classify the flow disruptions. Of the 1,470 events observed, interruptions were most prevalent (66.67%), followed by coordination issues (15.37%) and communication breakdowns (8.37%). Layout (7.21%), equipment (1.77%), and usability (0.61%) issues accounted for the remainder of the disruptions. Perioperative leaders should work with staff members to minimize workflow disruptions and provide support for identifying and documenting flow disruptions.
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Quirófanos , Seguridad del Paciente , Comunicación , Personal de Salud , Humanos , Flujo de TrabajoRESUMEN
This article explores the role of human factors engineering in patient safety in surgery. The authors discuss the history and evolution of human factors and the role of human factors in patient safety and provide a description of human factors methods used to study and improve patient safety.
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Ergonomía , Seguridad del Paciente/normas , Procedimientos Quirúrgicos Operativos/normas , HumanosRESUMEN
INTRODUCTION: As a result of COVID-19, several clinics have adopted telemedicine to safely deliver care. However, the introduction of a new technology into an already complex system creates new challenges that have the potential to negatively impact patient and provider experience. We aimed to use a human factors approach (the science concerned with understanding the interactions between humans and other elements in a complex system) to identify where systemic vulnerabilities may exist throughout the patient/provider experience with telemedicine. METHODS: A total of 23 patients scheduled for telemedicine consults were observed during visits with providers. A trained human factors observer documented disruptions to system efficiency (eg communication breakdowns, connectivity problems and interruptions) and invited patients and providers to take a survey investigating perceptions of telemedicine technology usability, satisfaction with the experience and opportunities to improve the process. RESULTS: Visits lasted an average of 17 minutes, 20 seconds and each visit had an average of 6 disruptions. Inefficiencies were categorized into 13 categories consisting mainly of interruptions (21, 15.22%), Internet connectivity issues (21, 15.22%), nonoptimal device setup (19, 13.77%) and repeat communication (18, 13.04%). Provider satisfaction with the system was 3.72/5.00 and perceived usability was 63.15 (68 is considered acceptable). Patient satisfaction was 4.80/5.00 and perceived usability was 85. CONCLUSIONS: These findings highlight opportunities for a multifaceted intervention, including the development of an informational sheet/video for patients, a telemedicine "best practices" guideline for physicians, a standardized training process and checklist for front office staff and an in-service training for the entire care team.
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OBJECTIVES: To apply a human factors approach, the study of interactions between humans and complex systems, to investigate patient preparedness, satisfaction, and perceived usability with sacral neuromodulation (SNM) and develop interventions aimed at improving patient experience. MATERIALS AND METHODS: Ten patients with overactive bladder undergoing staged SNM were observed, and data including pre-operative preparedness, satisfaction, perceived usability and barriers impacting patient experience were collected. Interventions were developed and an additional ten patients were observed. All patients were English-speaking and at least 18 years of age. RESULTS: Pre-intervention patients had difficulty understanding the risks of the procedure, did not know what to expect post-operatively and were unsatisfied with pre-operative materials. Interventions included: A pre-procedure educational video and informational sheet, detailed discharge instructions; and a nursing inservice. Pre-operative preparedness (Stage I: U = 100, z = 3.785, P = .000; Stage II: U = 80, z = 2.864, P = .003), post-operative satisfaction (Stage I: U = 100, z = 3.788, P = .000; Stage II: U = 77.5, z = 2.665, P = .006.) and perceptions of usability (Stage I: U = 77.00, z = 2.056, P = .043.; Stage II: U = 80.50, z = 2.308, P = .019) increased significantly after the intervention. CONCLUSION: Our observations highlight the value of implementing a human factors approach to identify and mitigate barriers impacting patient experiences with SNM. Through the implementation of systems-level interventions (ie, interventions that impact the non-clinical aspects of surgery such as patient and/or staff education), significant improvements can be made.
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Neuroestimuladores Implantables , Educación del Paciente como Asunto , Satisfacción del Paciente , Vejiga Urinaria Hiperactiva/terapia , Adulto , Anciano , Anciano de 80 o más Años , Educación en Enfermería , Terapia por Estimulación Eléctrica , Ergonomía/métodos , Femenino , Humanos , Neuroestimuladores Implantables/efectos adversos , Capacitación en Servicio , Masculino , Persona de Mediana Edad , Alta del Paciente , Complicaciones Posoperatorias/etiología , Periodo Posoperatorio , Periodo Preoperatorio , Estudios Prospectivos , Implantación de Prótesis/efectos adversos , SacroRESUMEN
OBJECTIVES: To use a human factors approach to conduct a needs assessment of patient preparedness, education, device usability, and satisfaction regarding all stages of sacral neuromodulation therapy and identify opportunities for improvement. Sacral neuromodulation, though minimally invasive, involves an initial testing phase that requires active patient participation. This process is relatively complex and, if a patient does not receive adequate preprocedure education, can be difficult to conceptualize. MATERIALS AND METHODS: Candidates were recruited to participate before undergoing staged sacral neuromodulation. Ten patients were observed, and their experiences were evaluated at 4 phases: (1) date of test implant (Stage I), (2) 5 days following Stage I, (3) date of permanent implant (Stage II), and (4) 3 months following Stage II. Administered questionnaires focused on preoperative preparedness, postoperative satisfaction, and usability. RESULTS: While every patient reported that their symptoms were at least "a little better" postoperatively, they generally had difficulty understanding the risks of the planned procedure, did not know what to expect postoperatively and were unsatisfied with the preoperative materials. Patients struggled with adjusting the settings for their implant devices and usability was considered "below average." Despite overall objective success, 30% of patients indicated that they would not recommend this treatment to friends/family. CONCLUSION: This pilot needs analysis demonstrates several opportunities for improvement in the experience of patients undergoing sacral neuromodulation. These findings highlight the opportunities for a multifaceted intervention to improve patient understanding through the testing phase.
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Terapia por Estimulación Eléctrica , Satisfacción del Paciente , Vejiga Urinaria Hiperactiva/terapia , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Persona de Mediana Edad , Evaluación de Necesidades , Estudios ProspectivosRESUMEN
BACKGROUND: The integration of high technology into health care systems is intended to provide new treatment options and improve the quality, safety, and efficiency of care. Robotic-assisted surgery is an example of high technology integration in health care, which has become ubiquitous in many surgical disciplines. OBJECTIVE: This study aims to understand and measure current robotic-assisted surgery processes in a systematic, quantitative, and replicable manner to identify latent systemic threats and opportunities for improvement based on our observations and to implement and evaluate interventions. This 5-year study will follow a human factors engineering approach to improve the safety and efficiency of robotic-assisted surgery across 4 US hospitals. METHODS: The study uses a stepped wedge crossover design with 3 interventions, introduced in different sequences at each of the hospitals over four 8-month phases. Robotic-assisted surgery procedures will be observed in the following specialties: urogynecology, gynecology, urology, bariatrics, general, and colorectal. We will use the data collected from observations, surveys, and interviews to inform interventions focused on teamwork, task design, and workplace design. We intend to evaluate attitudes toward each intervention, safety culture, subjective workload for each case, effectiveness of each intervention (including through direct observation of a sample of surgeries in each observational phase), operating room duration, length of stay, and patient safety incident reports. Analytic methods will include statistical data analysis, point process analysis, and thematic content analysis. RESULTS: The study was funded in September 2018 and approved by the institutional review board of each institution in May and June of 2019 (CSMC and MDRH: Pro00056245; VCMC: STUDY 270; MUSC: Pro00088741). After refining the 3 interventions in phase 1, data collection for phase 2 (baseline data) began in November 2019 and was scheduled to continue through June 2020. However, data collection was suspended in March 2020 due to the COVID-19 pandemic. We collected a total of 65 observations across the 4 sites before the pandemic. Data collection for phase 2 was resumed in October 2020 at 2 of the 4 sites. CONCLUSIONS: This will be the largest direct observational study of surgery ever conducted with data collected on 680 robotic surgery procedures at 4 different institutions. The proposed interventions will be evaluated using individual-level (workload and attitude), process-level (perioperative duration and flow disruption), and organizational-level (safety culture and complications) measures. An implementation science framework is also used to investigate the causes of success or failure of each intervention at each site and understand the potential spread of the interventions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25284.