Cognitive Aids in Obstetric Units: Design, Implementation, and Use.

Obstetrics has unique considerations for high stakes and dynamic clinical care of ≥2 patients. Obstetric crisis situations require efficient and coordinated responses from the entire multidisciplinary team. Actions that teams perform, or omit, can strongly impact peripartum and perinatal outcomes. Cognitive aids are tools that aim to improve patient safety, efficiency in health care management, and patient outcomes. However, they are intended to be combined with clinician judgment and training, not as absolute or exhaustive standards of care for patient management. There is simulation-based evidence showing efficacy of cognitive aids for enhancing appropriate team management during crises, especially with a reader role, with growing literature supporting use in obstetric and nonobstetric clinical settings when combined with local customization and implementation efforts. The purpose of this article is to summarize current understanding and available resources for cognitive aid design, implementation, and use in obstetrics and to highlight existing gaps that can stimulate further enhancement in this field.

Clinical Uses and Impacts of Emergency Manuals During Perioperative Crises.

BACKGROUND: Performing key actions efficiently during crises can determine clinical outcomes, yet even expert clinicians omit key actions. Simulation-based studies of crises show that correct performance of key actions dramatically increases when emergency manuals (EMs) are used. Despite widespread dissemination of EMs, there is a need to understand in clinical contexts, when, how, and how often EMs are used and not used, along with perceived impacts. METHODS: We conducted interviews with the anesthesia professionals involved in perioperative crises, identified with criterion-based sampling, occurring between October 2014 and May 2016 at 2 large academic medical centers with a history of EM training and implementation. Our convergent, mixed-methods study of the interview data extracted quantitative counts and qualitative themes of EM use and nonuse during clinical crises. RESULTS: Interviews with 53 anesthesia professionals yielded 80 descriptions of applicable clinical crises, with varying durations and event types. Of 69 unique patients whose cases involved crises, the EM was used during 37 (54%; 95% confidence interval [CI], 41-66). Impacts on clinician team members included decreased stress for individual anesthesia professionals (95%), enabled teamwork (73%), and calmed atmosphere (46%). Impacts on delivery of patient care included specific action improvements, including catching errors of omission, for example, turning off anesthetic during cardiac arrest, only after EM use (59%); process improvements, for example, double-checking all actions were completed (41%); and impediments (0%). In 8% of crises, EM use was associated with potential distractions, although none were perceived to harm delivery of patient care. For 32 EM nonuses (46%; 95% CI, 34-59), participants self-identified errors of omission or delays in key actions (56%), all key actions performed (13%), and crisis too brief for EM to be used (31%). CONCLUSIONS: This study provides evidence that EMs in operating rooms are being used during many applicable crises and that clinicians perceive EM use to add value. The reported negative effects were minimal and potentially offset by positive effects.

Ten years of the Helsinki Declaration on patient safety in anaesthesiology: An expert opinion on peri-operative safety aspects.

: Patient safety is an activity to mitigate preventable patient harm that may occur during the delivery of medical care. The European Board of Anaesthesiology (EBA)/European Union of Medical Specialists had previously published safety recommendations on minimal monitoring and postanaesthesia care, but with the growing public and professional interest it was decided to produce a much more encompassing document. The EBA and the European Society of Anaesthesiology (ESA) published a consensus on what needs to be done/achieved for improvement of peri-operative patient safety. During the Euroanaesthesia meeting in Helsinki/Finland in 2010, this vision was presented to anaesthesiologists, patients, industry and others involved in health care as the 'Helsinki Declaration on Patient Safety in Anaesthesiology'. In May/June 2020, ESA and EBA are celebrating the 10th anniversary of the Helsinki Declaration on Patient Safety in Anaesthesiology; a good opportunity to look back and forward evaluating what was achieved in the recent 10 years, and what needs to be done in the upcoming years. The Patient Safety and Quality Committee (PSQC) of ESA invited experts in their fields to contribute, and these experts addressed their topic in different ways; there are classical, narrative reviews, more systematic reviews, political statements, personal opinions and also original data presentation. With this publication we hope to further stimulate implementation of the Helsinki Declaration on Patient Safety in Anaesthesiology, as well as initiating relevant research in the future.

Use of an Emergency Manual During an Intraoperative Cardiac Arrest by an Interprofessional Team: A Positive-Exemplar Case Study of a New Patient Safety Tool.

BACKGROUND: An emergency manual (EM) is a set of evidence-based crisis checklists, or cognitive aids, that can improve team performance. EMs are used in other safety-critical industries, and health care simulation studies have shown their efficacy, but use in clinical settings is nascent. A case study was conducted on the use of an EM during one intraoperative crisis, which entailed the assessment of the impact of the EM's use on teamwork and patient care and the identification of lessons for effectively using EMs during future clinical crises. METHODS: In a case study of a single crisis, an EM was used during a cardiac arrest at a tertiary care hospital that had systematically implemented perioperative EMs. Semistructured interviews were conducted with all six clinicians present, interview transcripts were iteratively coded, and thematic analysis was performed. RESULTS: All clinician participants stated that EM use enabled effective team functioning via reducing stress of individual clinicians, fostering a calm work environment, and improving teamwork and communication. These impacts in turn improved the delivery of patient care during a clinical crisis and influenced participants' intended EM use during future appropriate crises. CONCLUSION: In this positive-exemplar case study, an EM was used to improve delivery of evidence-based patient care through effective clinical team functioning. EM use must complement rather than replace good clinician education, judgment, and teamwork. More broadly, understanding why and how things go well via analyzing positive-exemplar case studies, as a converse of root cause analyses for negative events, can be used to identify effective applications of safety innovations.

Emergency Manual Uses During Actual Critical Events and Changes in Safety Culture From the Perspective of Anesthesia Residents: A Pilot Study.

BACKGROUND: Emergency manuals (EMs), context-relevant sets of cognitive aids or crisis checklists, have been used in high-hazard industries for decades, although this is a nascent field in health care. In the fall of 2012, Stanford clinically implemented EMs, including hanging physical copies in all Stanford operating rooms (ORs) and training OR clinicians on the use of, and rationale for, EMs. Although simulation studies have shown the effectiveness of EMs and similar tools when used by OR teams during crises, there are little data on clinical implementations and uses. In a subset of clinical users (ie, anesthesia residents), the objectives of this pilot study were to (1) assess perspectives on local OR safety culture regarding cognitive aid use before and after a systematic clinical implementation of EMs, although in the context of long-standing resident simulation trainings; and (2) to describe early clinical uses of EMs during critical events. METHODS: Surveys collecting both quantitative and qualitative data were used to assess clinical adoption of EMs in the OR. A pre-implementation survey was e-mailed to Stanford anesthesia residents in mid-2011, followed by a post-implementation survey to a new cohort of residents in early 2014. The post-implementation survey included pre-implementation survey questions for exploratory comparison and additional questions for mixed-methods descriptive analyses regarding EM implementation, training, and clinical use during critical events since implementation. RESULTS: Response rates were similar for the pre- and post-implementation surveys, 52% and 57%, respectively. Comparing post- versus pre-implementation surveys in this pilot study, more residents: agreed or strongly agreed "the culture in the ORs where I work supports consulting a cognitive aid when appropriate" (73.8%, n = 31 vs 52.9%, n = 18, P = .0017) and chose more types of anesthesia professionals that "should use cognitive aids in some way," including fully trained anesthesiologists (z = -2.151, P = .0315). Fifteen months after clinical implementation of EMs, 19 respondents (45%) had used an EM during an actual critical event and 15 (78.9% of these) agreed or strongly agreed "the EM helped the team deliver better care to the patient" during that event, with the rest neutral. We present qualitative data for 16 of the 19 EM clinical use reports from free-text responses within the following domains: (1) triggering EM use, (2) reader role, (3) diagnosis and treatment, (4) patient care impact, and (5) barriers to EM use. CONCLUSIONS: Since Stanford's clinical implementation of EMs in 2012, many residents' self-report successful use of EMs during clinical critical events. Although these reports all come from a pilot study at a single institution, they serve as an early proof of concept for feasibility of clinical EM implementation and use. Larger, mixed-methods studies will be needed to better understand emerging facilitators and barriers and to determine generalizability.

Emergency manual implementation: can brief simulation-based or staff trainings increase familiarity and planned clinical use?

BACKGROUND: Emergency manuals (EMs)-context-relevant sets of cognitive aids such as crisis checklists-are useful tools to enhance perioperative patient care. Studies in high-hazard industries demonstrate that humans, regardless of expertise, do not optimally retrieve or deploy key knowledge under stress. EM use has been shown in both health care simulation studies and other industries to help expert teams effectively manage critical events. However, clinical adoption and use are still nascent in health care. Recognizing that training with, access to, and cultural acceptance of EMs can be vital elements for successful implementation, this study assessed the impact of a brief in situ operating room (OR) staff training program on familiarity with EMs and intention to use them during critical events. METHODS: Nine 50-minute training sessions were held with OR staff as part of a broader perioperative EM implementation. Participants primarily included OR nurses and surgical technologists. The simulation-based in situ trainings included why and how to use EMs, familiarization with format, simulated scenarios of critical events, and debriefings. A retrospective pre-post survey was conducted to determine participants' levels of EM familiarity and intentions to use EMs clinically. RESULTS: The 126 trained OR staff self-reported increases in awareness of the EM (p < .01), familiarity with EM (p < .01), willingness to use for educational review (p < .01), and intention to use during critical events (p < .01). Participants rated the sessions highly and expressed interest in more opportunities to practice using EMs. CONCLUSIONS: Implementing institutions should not only provide EMs in accessible places in ORs but also incorporate training mechanisms to increase clinicians' familiarity, cultural acceptance, and planned clinical use.

Simulation exercises as a patient safety strategy: a systematic review.

Simulation is a versatile technique used in a variety of health care settings for a variety of purposes, but the extent to which simulation may improve patient safety remains unknown. This systematic review examined evidence on the effects of simulation techniques on patient safety outcomes. PubMed and the Cochrane Library were searched from their beginning to 31 October 2012 to identify relevant studies. A single reviewer screened 913 abstracts and selected and abstracted data from 38 studies that reported outcomes during care of real patients after patient-, team-, or system-level simulation interventions. Studies varied widely in the quality of methodological design and description of simulation activities, but in general, simulation interventions improved the technical performance of individual clinicians and teams during critical events and complex procedures. Limited evidence suggested improvements in patient outcomes attributable to simulation exercises at the health system level. Future studies would benefit from standardized reporting of simulation components and identification of robust patient safety targets.

Implementing emergency manuals: can cognitive aids help translate best practices for patient care during acute events?

In this article, we address whether emergency manuals are an effective means of helping anesthesiologists and perioperative teams apply known best practices for critical events. We review the relevant history of such cognitive aids in health care, as well as examples from other high stakes industries, and describe why emergency manuals have a role in improving patient care during certain events. We propose 4 vital elements: create, familiarize, use, and integrate, necessary for the widespread, successful development, and implementation of medical emergency manuals, using the specific example of the perioperative setting. The details of each element are presented, drawing from the medical literature as well as from our combined experience of more than 30 years of observing teams of anesthesiologists managing simulated and real critical events. We emphasize the importance of training clinicians in the use of emergency manuals for education on content, format, and location. Finally, we discuss cultural readiness for change, present a system example of successful integration, and highlight the importance of further research on the implementation of emergency manuals.

Emergency manual peri-crisis use six years following implementation: Sustainment of an intervention for rare crises.

STUDY OBJECTIVE: Use of cognitive aids during emergencies increases key actions and decreases omissions, both known to save lives. With little known about emergency manual (EM) clinical use, we aimed to help answer "Will EMs be used peri-crisis at a meaningful frequency?" and to explore clinical sustainment. DESIGN: Prospective, observational study. SETTING: Operating Rooms. PATIENTS: All patients undergoing anesthesia at a major academic medical center during the study periods; ∼75,000 cases. INTERVENTION & MEASUREMENTS: To understand the initial and sustainment phases of EM implementation, we placed a question regarding EM use at the end of every anesthetic case to prospectively measure EM use at: implementation, one-year later, and six years post-implementation. MAIN RESULTS: For more than twenty-four thousand cases in each approximately 6-month study period, EMs were used peri-crisis (before, during or after a perioperative crisis) in 145 cases initially (0.55%; SE 0.045%), 42 cases one-year later (0.17%; SE 0.026%), and 57 cases (0.21%; SE 0.028%) six years post-implementation. Peri-crisis EM uses dropped 0.38% (97.5% CI: 0.26%, 0.49%) from initial to one-year post-implementation. After that, peri-crisis EM uses did not differ significantly from one-year to six years post-implementation, showing sustainment [increased 0.04% (97.5% CI: -0.05%, 0.12%)]. Among cases with cardiac arrest or CPR, as a subset proxy for relevant crises, EMs were used in 7/13 such cases initially (54%, SE 13.6%), 8/20 one-year later (40%; SE 10.9%) and 7/13 six years later (54%; SE 13.6%). CONCLUSIONS: After an initial expected drop, EM peri-crisis use six years post-implementation was: sustained without intensive additional efforts, averaged ∼10 times per month at a single institution, and was reported in more than half of cases with cardiac arrest or CPR. Peri-crisis use of EMs is appropriately rare, though for relevant crises can have substantial positive impacts as described in prior literature. The sustained use of EMs may be related to increasing cultural acceptance of EMs, as reflected in survey result trends and broader cognitive aid literature.

Perceptions of Use of Names, Recognition of Roles, and Teamwork After Labeling Surgical Caps.

Importance: Communication failures in perioperative areas are common and have negative outcomes for both patients and clinicians. Names and roles of teammates are difficult to remember or discern contributing to suboptimal communication, yet the utility of labeled surgical caps with names and roles for enhancing perceived teamwork and connection is not well studied. Objective: To evaluate the use of labeled surgical caps in name use and role recognition, as well as teamwork and connection, among interprofessional perioperative teammates. Design, Setting, and Participants: In this quality improvement study, caps labeled with names and roles were distributed to 967 interprofessional perioperative clinicians, along with preimplementation and 6-month postimplementation surveys. Conducted between July 8, 2021, and June 25, 2022, at a single large, academic, quaternary health care center in the US, the study comprised surgeons, anesthesiologists, trainees, and all interprofessional hospital staff who work in adult general surgery perioperative areas. Intervention: Labeled surgical caps were offered cost-free, although not mandatory, to each interested clinician. Main Outcome and Measure: Quantitative survey of self-reported frequency for name use and role recognition as well as postimplementation sense of teamwork and connection. The surveys also elicited free response comments. Results: Of the 1483 eligible perioperative clinicians, 967 (65%; 387 physicians and 580 nonphysician staff; 58% female) completed preimplementation surveys and received labeled caps, and 243 of these individuals (51% of physicians and 8% of staff) completed postimplementation surveys. Pre-post results were limited to physicians, due to the low postsurvey staff response rate. The odds of participants reporting that they were often called by their name increased after receiving a labeled cap (adjusted odds ratio [AOR], 13.37; 95% CI, 8.18-21.86). On postsurveys, participants reported that caps with names and roles substantially improved teamwork (80%) and connection (79%) with teammates. Participants who reported an increased frequency of being called by their name had higher odds for reporting improved teamwork (AOR, 3.46; 95% CI, 1.91-6.26) and connection with teammates (AOR, 3.21; 95% CI, 1.76-5.84). Free response comments supported the quantitative data that labeled caps facilitated knowing teammates' names and roles and fostered a climate of wellness, teamwork, inclusion, and patient safety. Conclusions and Relevance: The findings of this quality improvement study performed with interprofessional teammates suggest that organizationally sponsored labeled surgical caps was associated with improved teamwork, indicated by increased name use and role recognition in perioperative areas.

What's in a Name? Enhancing Communication in the Operating Room with the Use of Names and Roles on Surgical Caps.

OBJECTIVE: A pilot study was conducted in a tertiary referral center to assess whether wearing caps labeled with providers' names and roles has an impact on communication in the operating room (OR). METHODS: Two obstetricians observed surgeries for name uses and missed communications. Following each case, all providers were given a short survey that queried their attitude about the use of labeled surgical caps, their ability to know the names and roles of other providers during a case, and the impact of scrub attire on identifying others. They were also asked to rate the ease of communication and their ability to recall name and roles of the personnel specific to the case. Patients were asked how they perceived the use of labeled caps by providers. RESULTS: Twenty scheduled cesarean deliveries were randomized to either labeled (10) or nonlabeled (10) surgical caps. A total of 129 providers participated in the study, with 117 providing responses to the survey. Providers reported knowing the names and roles of colleagues more often with labeled caps vs. nonlabeled caps (names: 77.8% vs. 55.0%, 95% confidence interval [CI] = 64.4%-88.0% vs. 41.6%-67.9%, p = 0.011; roles: 92.5% vs. 78.3%, 95% CI = 81.8%-98.0% vs. 65.8%-88.0%, p = 0.036). Name uses increased (43 vs. 34, p = 0.208), and missed communications decreased (16 vs. 20, p = 0.614) when labeled caps were worn. Providers and patients had an overwhelmingly positive response to labeled caps. CONCLUSION: This pilot study demonstrated that wearing labeled caps in the OR led to more frequent name uses and less frequent missed communications. Providers and patients embraced the concept of labeled caps and perceived wearing labeled caps as improving communication in the OR.

Bringing Perioperative Emergency Manuals to Your Institution: A "How To" from Concept to Implementation in 10 Steps.

BACKGROUND: Emergency manuals (EMs) are context-relevant sets of crisis checklists or cognitive aids designed to enable professional teams to deliver optimal care during critical events. Evidence from simulation and other high-risk industries have proven that use of these types of checklists can significantly improve event management and decrease omissions of key steps. However, simply printing and placing tools in operating rooms (ORs) is unlikely to be effective. How interventions are implemented influences whether clinicians actually change practice and whether patient care is affected. This article provides an in-depth description of a rigorous implementation plan with three goals: (1) place EMs in every anesthetizing location, (2) create interprofessional engagement, and (3) demonstrate that a majority of anesthesia clinicians would use the new tool in some way within the first year. METHODS: The implementation of EMs included 10 steps across four distinct phases. EM use was measured using an electronic quality assurance tool, with data collected after each case about whether and how the EM was used. RESULTS: During the six months following implementation, 67.0% of clinicians had used the manual, with 24.1% using it for clinical care and 9.2% using it during a critical event. CONCLUSION: This article presents a framework and detailed description of the steps a large academic institution followed in successfully implementing EMs. In conjunction with other available resources, those interested in introducing OR EMs at large, complex institutions may benefit from the experience shared in anticipating challenges and overcoming barriers to adoption.

Emergency Manuals: How Quality Improvement and Implementation Science Can Enable Better Perioperative Management During Crises.

How can teams manage critical events more effectively? There are commonly gaps in performance during perioperative crises, and emergency manuals are recently available tools that can improve team performance under stress, via multiple mechanisms. This article examines how the principles of implementation science and quality improvement were applied by multiple teams in the development, testing, and systematic implementations of emergency manuals in perioperative care. The core principles of implementation have relevance for future patient safety innovations perioperatively and beyond, and the concepts of emergency manuals and interprofessional teamwork are applicable for diverse fields throughout health care.

Factors associated with the use of cognitive aids in operating room crises: a cross-sectional study of US hospitals and ambulatory surgical centers.

BACKGROUND: Operating room (OR) crises are high-acuity events requiring rapid, coordinated management. Medical judgment and decision-making can be compromised in stressful situations, and clinicians may not experience a crisis for many years. A cognitive aid (e.g., checklist) for the most common types of crises in the OR may improve management during unexpected and rare events. While implementation strategies for innovations such as cognitive aids for routine use are becoming better understood, cognitive aids that are rarely used are not yet well understood. We examined organizational context and implementation process factors influencing the use of cognitive aids for OR crises. METHODS: We conducted a cross-sectional study using a Web-based survey of individuals who had downloaded OR cognitive aids from the websites of Ariadne Labs or Stanford University between January 2013 and January 2016. In this paper, we report on the experience of 368 respondents from US hospitals and ambulatory surgical centers. We analyzed the relationship of more successful implementation (measured as reported regular cognitive aid use during applicable clinical events) with organizational context and with participation in a multi-step implementation process. We used multivariable logistic regression to identify significant predictors of reported, regular OR cognitive aid use during OR crises. RESULTS: In the multivariable logistic regression, small facility size was associated with a fourfold increase in the odds of a facility reporting more successful implementation (p = 0.0092). Completing more implementation steps was also significantly associated with more successful implementation; each implementation step completed was associated with just over 50% higher odds of more successful implementation (p ≤ 0.0001). More successful implementation was associated with leadership support (p < 0.0001) and dedicated time to train staff (p = 0.0189). Less successful implementation was associated with resistance among clinical providers to using cognitive aids (p < 0.0001), absence of an implementation champion (p = 0.0126), and unsatisfactory content or design of the cognitive aid (p = 0.0112). CONCLUSIONS: Successful implementation of cognitive aids in ORs was associated with a supportive organizational context and following a multi-step implementation process. Building strong organizational support and following a well-planned multi-step implementation process will likely increase the use of OR cognitive aids during intraoperative crises, which may improve patient outcomes.

Randomized controlled community-based nutrition and exercise intervention improves glycemia and cardiovascular risk factors in type 2 diabetic patients in rural Costa Rica.

OBJECTIVE: The prevalence of type 2 diabetes, especially in developing countries, has grown over the past decades. We performed a controlled clinical study to determine whether a community-based, group-centered public health intervention addressing nutrition and exercise can ameliorate glycemic control and associated cardiovascular risk factors in type 2 diabetic patients in rural Costa Rica. RESEARCH DESIGN AND METHODS: A total of 75 adults with type 2 diabetes, mean age 59 years, were randomly assigned to the intervention group or the control group. All participants received basic diabetes education. The subjects in the intervention group participated in 11 weekly nutrition classes (90 min each session). Subjects for whom exercise was deemed safe also participated in triweekly walking groups (60 min each session). Glycosylated hemoglobin, fasting plasma glucose, total cholesterol, triglycerides, HDL and LDL cholesterol, height, weight, BMI, and blood pressure were measured at baseline and the end of the study (after 12 weeks). RESULTS: The intervention group lost 1.0 +/- 2.2 kg compared with a weight gain in the control group of 0.4 +/- 2.3 kg (P = 0.028). Fasting plasma glucose decreased 19 +/- 55 mg/dl in the intervention group and increased 16 +/- 78 mg/dl in the control group (P = 0.048). Glycosylated hemoglobin decreased 1.8 +/- 2.3% in the intervention group and 0.4 +/- 2.3% in the control group (P = 0.028). CONCLUSIONS: Glycemic control of type 2 diabetic patients can be improved through community-based, group-centered public health interventions addressing nutrition and exercise. This pilot study provides an economically feasible model for programs that aim to improve the health status of people with type 2 diabetes.