Assessment of implementation methods in sepsis: study protocol for a cluster-randomized hybrid type 2 trial.

BACKGROUND: Sepsis is the leading cause of intensive care unit (ICU) admission and ICU death. In recognition of the burden of sepsis, the Surviving Sepsis Campaign (SSC) and the Institute for Healthcare Improvement developed sepsis "bundles" (goals to accomplish over a specific time period) to facilitate SSC guideline implementation in clinical practice. Using the SSC 3-h bundle as a base, the Centers for Medicare and Medicaid Services developed a 3-h sepsis bundle that has become the national standard for early management of sepsis. Emerging observational data, from an analysis conducted for the AIMS grant application, suggest there may be additional mortality benefit from even earlier implementation of the 3-h bundle, i.e., the 1-h bundle. METHOD: The primary aims of this randomized controlled trial are to: (1) examine the effect on clinical outcomes of Emergency Department initiation of the elements of the 3-h bundle within the traditional 3 h versus initiating within 1 h of sepsis recognition and (2) examine the extent to which a rigorous implementation strategy will improve implementation and compliance with both the 1-h bundle and the 3-h bundle. This study will be entirely conducted in the Emergency Department at 18 sites. A secondary aim is to identify clinical sepsis phenotypes and their impact on treatment outcomes. DISCUSSION: This cluster-randomized trial, employing implementation science methodology, is timely and important to the field. The hybrid effectiveness-implementation design is likely to have an impact on clinical practice in sepsis management by providing a rigorous evaluation of the 1- and 3-h bundles. FUNDING: NHLBI R01HL162954. TRIAL REGISTRATION: ClinicalTrials.gov NCT05491941. Registered on August 8, 2022.

Implementation of a Virtual Interprofessional ICU Learning Collaborative: Successes, Challenges, and Initial Reactions From the Structured Team-Based Optimal Patient-Centered Care for Virus COVID-19 Collaborators.

Initial Society of Critical Care Medicine Discovery Viral Infection and Respiratory illness Universal Study (VIRUS) Registry analysis suggested that improvements in critical care processes offered the greatest modifiable opportunity to improve critically ill COVID-19 patient outcomes. OBJECTIVES: The Structured Team-based Optimal Patient-Centered Care for Virus COVID-19 ICU Collaborative was created to identify and speed implementation of best evidence based COVID-19 practices. DESIGN SETTING AND PARTICIPANTS: This 6-month project included volunteer interprofessional teams from VIRUS Registry sites, who received online training on the Checklist for Early Recognition and Treatment of Acute Illness and iNjury approach, a structured and systematic method for delivering evidence based critical care. Collaborators participated in weekly 1-hour videoconference sessions on high impact topics, monthly quality improvement (QI) coaching sessions, and received extensive additional resources for asynchronous learning. MAIN OUTCOMES AND MEASURES: Outcomes included learner engagement, satisfaction, and number of QI projects initiated by participating teams. RESULTS: Eleven of 13 initial sites participated in the Collaborative from March 2, 2021, to September 29, 2021. A total of 67 learners participated in the Collaborative, including 23 nurses, 22 physicians, 10 pharmacists, nine respiratory therapists, and three nonclinicians. Site attendance among the 11 sites in the 25 videoconference sessions ranged between 82% and 100%, with three sites providing at least one team member for 100% of sessions. The majority reported that topics matched their scope of practice (69%) and would highly recommend the program to colleagues (77%). A total of nine QI projects were initiated across three clinical domains and focused on improving adherence to established critical care practice bundles, reducing nosocomial complications, and strengthening patient- and family-centered care in the ICU. Major factors impacting successful Collaborative engagement included an engaged interprofessional team; an established culture of engagement; opportunities to benchmark performance and accelerate institutional innovation, networking, and acclaim; and ready access to data that could be leveraged for QI purposes. CONCLUSIONS AND RELEVANCE: Use of a virtual platform to establish a learning collaborative to accelerate the identification, dissemination, and implementation of critical care best practices for COVID-19 is feasible. Our experience offers important lessons for future collaborative efforts focused on improving ICU processes of care.

A multisite exploration of the association between critical care implementation factors and clinical outcomes during the COVID-19 pandemic.

Background: Little is known about strategies to implement new critical care practices in response to COVID-19. Moreover, the association between differing implementation climates and COVID-19 clinical outcomes has not been examined. The purpose of this study was to evaluate the relationship between implementation determinants and COVID-19 mortality rates. Methods: We used mixed methods guided by the Consolidated Framework for Implementation Research (CFIR). Semi-structured qualitative interviews were conducted with critical care leaders and analyzed to rate the influence of CFIR constructs on the implementation of new care practices. Qualitative and quantitative comparisons of CFIR construct ratings were performed between hospital groups with low- versus high-mortality rates. Results: We found associations between various implementation factors and clinical outcomes of critically ill COVID-19 patients. Three CFIR constructs (implementation climate, leadership engagement, and engaging staff) had both qualitative and statistically significant quantitative correlations with mortality outcomes. An implementation climate governed by a trial-and-error approach was correlated with high COVID-19 mortality, while leadership engagement and engaging staff were correlated with low mortality. Another three constructs (needs of patient; organizational incentives and rewards; and engaging implementation leaders) were qualitatively different across mortality outcome groups, but these differences were not statistically significant. Conclusions: Improving clinical outcomes during future public health emergencies will require reducing identified barriers associated with high mortality and harnessing salient facilitators associated with low mortality. Our findings suggest that collaborative and engaged leadership styles that promote the integration of new yet evidence-based critical care practices best support COVID-19 patients and contribute to lower mortality.

Operationalizing Appropriate Sepsis Definitions in Children Worldwide: Considerations for the Pediatric Sepsis Definition Taskforce.

Sepsis is a leading cause of global mortality in children, yet definitions for pediatric sepsis are outdated and lack global applicability and validity. In adults, the Sepsis-3 Definition Taskforce queried databases from high-income countries to develop and validate the criteria. The merit of this definition has been widely acknowledged; however, important considerations about less-resourced and more diverse settings pose challenges to its use globally. To improve applicability and relevance globally, the Pediatric Sepsis Definition Taskforce sought to develop a conceptual framework and rationale of the critical aspects and context-specific factors that must be considered for the optimal operationalization of future pediatric sepsis definitions. It is important to address challenges in developing a set of pediatric sepsis criteria which capture manifestations of illnesses with vastly different etiologies and underlying mechanisms. Ideal criteria need to be unambiguous, and capable of adapting to the different contexts in which children with suspected infections are present around the globe. Additionally, criteria need to facilitate early recognition and timely escalation of treatment to prevent progression and limit life-threatening organ dysfunction. To address these challenges, locally adaptable solutions are required, which permit individualized care based on available resources and the pretest probability of sepsis. This should facilitate affordable diagnostics which support risk stratification and prediction of likely treatment responses, and solutions for locally relevant outcome measures. For this purpose, global collaborative databases need to be established, using minimum variable datasets from routinely collected data. In summary, a "Think globally, act locally" approach is required.

Facilitators and barriers to the implementation of new critical care practices during COVID-19: a multicenter qualitative study using the Consolidated Framework for Implementation Research (CFIR).

BACKGROUND: The COVID-19 pandemic produced unprecedented demands and rapidly changing evidence and practices within critical care settings. The purpose of this study was to identify factors and strategies that hindered and facilitated effective implementation of new critical care practices and policies in response to the pandemic. METHODS: We used a cross-sectional, qualitative study design to conduct semi-structured in-depth interviews with critical care leaders across the United States. The interviews were audio-taped and professionally transcribed verbatim. Guided by the Consolidated Framework for Implementation Research (CFIR), three qualitative researchers used rapid analysis methods to develop relevant codes and identify salient themes. RESULTS: Among the 17 hospitals that agreed to participate in this study, 31 clinical leaders were interviewed. The CFIR-driven rapid analysis of the interview transcripts generated 12 major themes, which included six implementation facilitators (i.e., factors that promoted the implementation of new critical care practices) and six implementation barriers (i.e., factors that hindered the implementation of new critical care practices). These themes spanned the five CFIR domains (Intervention Characteristics, Outer Setting, Inner Setting, Characteristics of Individuals, and Process) and 11 distinct CFIR constructs. Salient facilitators to implementation efforts included staff resilience, commitment, and innovation, which were supported through collaborative feedback and decision-making mechanisms between leadership and frontline staff. Major identified barriers included lack of access to reliable and transferable information, available resources, uncollaborative leadership and communication styles. CONCLUSIONS: Through applying the CFIR to organize and synthesize our qualitative data, this study revealed important insights into implementation determinants that influenced the uptake of new critical care practices during COVID-19. As the pandemic continues to burden critical care units, clinical leaders should consider emulating the effective change management strategies identified. The cultivation of streamlined, engaging, and collaborative leadership and communication mechanisms not only supported implementation of new care practices across sites, but it also helped reduce salient implementation barriers, particularly resource and staffing shortages. Future critical care implementation studies should seek to capitalize on identified facilitators and reduce barriers.

The Initial Impact of the Coronavirus Disease 2019 Pandemic on ICU Family Engagement: Lessons Learned From a Collaborative of 27 ICUs.

OBJECTIVES: To describe the impact of coronavirus disease 2019 on family engagement among ICUs participating in a multicenter collaborative promoting implementation of family-centered care projects and to report sites' experiences with the collaborative itself prior to its cancelation due to the pandemic in March 2020. DESIGN: Cross-sectional survey. SETTING: Twenty-seven academic and community ICUs in the United States and South Korea. SUBJECTS: Site leaders. INTERVENTIONS: Prior to March 2020, all sites had participated in 6 months of webinars, monthly calls, and listserv communication to facilitate projects and to collect preimplementation family satisfaction and clinician perception data. MEASUREMENTS AND MAIN RESULTS: Planned projects included ICU orientation initiatives (12, 44.4%), structured family care conferences (6, 22.2%), and ICU diaries (5, 18.5%). After cancelation of the collaborative, 22 site leaders (81.5%) were surveyed by phone from June 2020 to July 2020. Twenty (90.1%) reported having stopped their site project; projects that continued were 1) a standardized palliative extubation protocol and 2) daily written clinical summaries for families. Sites described significant variability in visitor restriction policies and uncertainty regarding future policy changes. Four sites (18.2%) reported that their hospital did not provide personal protective equipment to visitors. Regarding video conferencing with families, 11 sites (52.4%) reported clinicians' using their own personal devices. Two-hundred twelve family surveys and 346 clinician surveys collected prior to cancelation highlighted a broad need for family support. When leaders were asked on a scale from 0 to 10 how helpful collaborative activities had been prior to cancelation, mean response was 8.0 (sd 2.5). CONCLUSIONS: While the collaborative model can help promote ICU family engagement initiatives, coronavirus disease 2019 has impeded implementation of these initiatives even among motivated units. ICUs need adequate personal protective equipment for visitors and video conferencing capabilities on hospital devices while strict visitor restrictions continue to evolve.

Choosing Wisely For Critical Care: The Next Five.

OBJECTIVES: To formulate new "Choosing Wisely" for Critical Care recommendations that identify best practices to avoid waste and promote value while providing critical care. DATA SOURCES: Semistructured narrative literature review and quantitative survey assessments. STUDY SELECTION: English language publications that examined critical care practices in relation to reducing cost or waste. DATA EXTRACTION: Practices assessed to add no value to critical care were grouped by category. Taskforce assessment, modified Delphi consensus building, and quantitative survey analysis identified eight novel recommendations to avoid wasteful critical care practices. These were submitted to the Society of Critical Care Medicine membership for evaluation and ranking. DATA SYNTHESIS: Results from the quantitative Society of Critical Care Medicine membership survey identified the top scoring five of eight recommendations. These five highest ranked recommendations established Society of Critical Care Medicine's Next Five "Choosing" Wisely for Critical Care practices. CONCLUSIONS: Five new recommendations to reduce waste and enhance value in the practice of critical care address invasive devices, proactive liberation from mechanical ventilation, antibiotic stewardship, early mobilization, and providing goal-concordant care. These recommendations supplement the initial critical care recommendations from the "Choosing Wisely" campaign.

The inability to walk unassisted at hospital admission as a valuable triage tool to predict hospital mortality in Rwandese patients with suspected infection.

OBJECTIVE: To assess the value of the inability to walk unassisted to predict hospital mortality in patients with suspected infection in a resource-limited setting. METHODS: This is a post hoc study of a prospective trial performed in rural Rwanda. Patients hospitalized because of a suspected acute infection and who were able to walk unassisted before this disease episode were included. At hospital presentation, the walking status was graded into: 1) can walk unassisted, 2) can walk assisted only, 3) cannot walk. Receiver operating characteristic (ROC) analyses and two-by-two tables were used to determine the sensitivity, specificity, negative and positive predictive values of the inability to walk unassisted to predict in-hospital death. RESULTS: One-thousand-sixty-nine patients were included. Two-hundred-one (18.8%), 315 (29.5%), and 553 (51.7%) subjects could walk unassisted, walk assisted or not walk, respectively. Their hospital mortality was 0%, 3.8% and 6.3%, respectively. The inability to walk unassisted had a low specificity (20%) but was 100% sensitive (CI95%, 90-100%) to predict in-hospital death (p = 0.00007). The value of the inability to walk unassisted to predict in-hospital mortality (AUC ROC, 0.636; CI95%, 0.564-0.707) was comparable to that of the qSOFA score (AUC ROC, 0.622; CI95% 0.524-0.728). Fifteen (7.5%), 34 (10.8%) and 167 (30.2%) patients who could walk unassisted, walk assisted or not walk presented with a qSOFA score count ≥2 points, respectively (p<0.001). The inability to walk unassisted correlated with the presence of risk factors for death and danger signs, vital parameters, laboratory values, length of hospital stay, and costs of care. CONCLUSIONS: Our results suggest that the inability to walk unassisted at hospital admission is a highly sensitive predictor of in-hospital mortality in Rwandese patients with a suspected acute infection. The walking status at hospital admission appears to be a crude indicator of disease severity.

A Machine Learning-Based Triage Tool for Children With Acute Infection in a Low Resource Setting.

OBJECTIVES: To deploy machine learning tools (random forests) to develop a model that reliably predicts hospital mortality in children with acute infections residing in low- and middle-income countries, using age and other variables collected at hospital admission. DESIGN: Post hoc analysis of a single-center, prospective, before-and-after feasibility trial. SETTING: Rural district hospital in Rwanda, a low-income country in Sub-Sahara Africa. PATIENTS: Infants and children greater than 28 days and less than 18 years of life hospitalized because of an acute infection. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Age, vital signs (heart rate, respiratory rate, and temperature) capillary refill time, altered mental state collected at hospital admission, as well as survival status at hospital discharge were extracted from the trial database. This information was collected for 1,579 adult and pediatric patients admitted to a regional referral hospital with an acute infection in rural Rwanda. Nine-hundred forty-nine children were included in this analysis. We predicted survival in study subjects using random forests, a machine learning algorithm. Five prediction models, all including age plus two to five other variables, were tested. Three distinct optimization criteria of the algorithm were then compared. The in-hospital mortality was 1.5% (n = 14). All five models could predict in-hospital mortality with an area under the receiver operating characteristic curve ranging between 0.69 and 0.8. The model including age, respiratory rate, capillary refill time, altered mental state exhibited the highest predictive value area under the receiver operating characteristic curve 0.8 (95% CI, 0.78-0.8) with the lowest possible number of variables. CONCLUSIONS: A machine learning-based algorithm could reliably predict hospital mortality in a Sub-Sahara African population of 949 children with an acute infection using easily collected information at admission which includes age, respiratory rate, capillary refill time, and altered mental state. Future studies need to evaluate and strengthen this algorithm in larger pediatric populations, both in high- and low-/middle-income countries.

Assessment of Variability in End-of-Life Care Delivery in Intensive Care Units in the United States.

Importance: Overall, 1 of 5 decedents in the United States is admitted to an intensive care unit (ICU) before death. Objective: To describe structures, processes, and variability of end-of-life care delivered in ICUs in the United States. Design, Setting, and Participants: This nationwide cohort study used data on 16 945 adults who were cared for in ICUs that participated in the 68-unit ICU Liberation Collaborative quality improvement project from January 2015 through April 2017. Data were analyzed between August 2018 and June 2019. Main Outcomes and Measures: Published quality measures and end-of-life events, organized by key domains of end-of-life care in the ICU. Results: Of 16 945 eligible patients in the collaborative, 1536 (9.1%) died during their initial ICU stay. Of decedents, 654 (42.6%) were women, 1037 (67.5%) were 60 years or older, and 1088 (70.8%) were identified as white individuals. Wide unit-level variation in end-of-life care delivery was found. For example, the median unit-stratified rate of cardiopulmonary resuscitation avoidance in the last hour of life was 89.5% (interquartile range, 83.3%-96.1%; range, 50.0%-100%). Median rates of patients who were pain free and delirium free in last 24 hours of life were 75.1% (interquartile range, 66.0%-85.7%; range, 0-100%) and 60.0% (interquartile range, 43.7%-85.2%; range, 9.1%-100%), respectively. Ascertainment of an advance directive was associated with lower odds of cardiopulmonary resuscitation in the last hour of life (odds ratio, 0.70; 95% CI, 0.49-0.99; P = .04), and a documented offer or delivery of spiritual support was associated with higher odds of family presence at the time of death (odds ratio, 1.95; 95% CI, 1.37-2.77; P < .001). Death in a unit with an open visitation policy was associated with higher odds of pain in the last 24 hours of life (odds ratio, 2.21; 95% CI, 1.15-4.27; P = .02). Unsupervised cluster analysis revealed 3 mutually exclusive unit-level patterns of end-of-life care delivery among 63 ICUs with complete data. Cluster 1 units (14 units [22.2%]) had the lowest rate of cardiopulmonary resuscitation avoidance but achieved the highest pain-free rate. Cluster 2 (25 units [39.7%]) had the lowest delirium-free rate but achieved high rates of all other end-of-life events. Cluster 3 (24 units [38.1%]) achieved high rates across all favorable end-of-life events. Conclusions and Relevance: In this study, end-of-life care delivery varied substantially among ICUs in the United States, and the patterns of care observed suggest that units can be characterized as higher and lower performing. To achieve optimal care for patients who die in an ICU, future research should target unit-level variation and disseminate the successes of higher-performing units.

Promoting Family Engagement in the ICU: Experience From a National Collaborative of 63 ICUs.

OBJECTIVES: As part of an improvement program targeting ICU, a national collaborative was launched to help hospitals implement patient- and family-centered care engagement initiatives. DESIGN: Ten-month quality improvement collaborative. SETTING: Guided by a national patient and family advisory group, participating teams implemented an individual project including open visitation; integrating families on rounds; establishing a patient and family advisory committee; using patient and family diaries, among others. SUBJECTS: Sixty-three adult and PICU teams from both academic and community hospitals in 34 states participated. INTERVENTIONS: Monthly team calls, quarterly webinars, newsletters, an online eCommunity, and team reporting assignments were used to facilitate project implementation. MEASUREMENTS AND MAIN RESULTS: The Family Satisfaction with Care in the ICU 24 was used to assess family satisfaction. Clinician perceptions were assessed with the Institute for Patient- and Family-Centered Care Self-Assessment Inventory. Thematic analysis was used to explore narrative data captured from team reports of project barriers, facilitators, and the experience of participating in the collaborative. A total of 2,530 family member and 3,999 clinician surveys were completed. Postimplementation, family members reported statistically significant increases in overall family satisfaction, satisfaction with decision-making, and satisfaction with quality of care (Family Satisfaction with Care in the ICU mean score change range 0.83-1.24; p ≤ 0.027). Clinicians reported that opportunities for families to participate as members of the care team increased. Major barriers included lack of buy-in and ability to promote change in the clinical setting, managing the workload of implementation, and funding to support initiatives. CONCLUSIONS: A national collaborative format was useful to assist ICU teams to implement patient- and family-engagement initiatives. Enlisting stakeholder support, engaging unit-based champions, and highlighting benefits of family engagement can help ICU teams to promote family member involvement and engagement.

Criteria for Critical Care Infants and Children: PICU Admission, Discharge, and Triage Practice Statement and Levels of Care Guidance.

OBJECTIVES: To update the American Academy of Pediatrics and Society of Critical Care Medicine's 2004 Guidelines and levels of care for PICU. DESIGN: A task force was appointed by the American College of Critical Care Medicine to follow a standardized and systematic review of the literature using an evidence-based approach. The 2004 Admission, Discharge and Triage Guidelines served as the starting point, and searches in Medline (Ovid), Embase (Ovid), and PubMed resulted in 329 articles published from 2004 to 2016. Only 21 pediatric studies evaluating outcomes related to pediatric level of care, specialized PICU, patient volume, or personnel. Of these, 13 studies were large retrospective registry data analyses, six small single-center studies, and two multicenter survey analyses. Limited high-quality evidence was found, and therefore, a modified Delphi process was used. Liaisons from the American Academy of Pediatrics were included in the panel representing critical care, surgical, and hospital medicine expertise for the development of this practice guidance. The title was amended to "practice statement" and "guidance" because Grading of Recommendations, Assessment, Development, and Evaluation methodology was not possible in this administrative work and to align with requirements put forth by the American Academy of Pediatrics. METHODS: The panel consisted of two groups: a voting group and a writing group. The panel used an iterative collaborative approach to formulate statements on the basis of the literature review and common practice of the pediatric critical care bedside experts and administrators on the task force. Statements were then formulated and presented via an online anonymous voting tool to a voting group using a three-cycle interactive forecasting Delphi method. With each cycle of voting, statements were refined on the basis of votes received and on comments. Voting was conducted between the months of January 2017 and March 2017. The consensus was deemed achieved once 80% or higher scores from the voting group were recorded on any given statement or where there was consensus upon review of comments provided by voters. The Voting Panel was required to vote in all three forecasting events for the final evaluation of the data and inclusion in this work. The writing panel developed admission recommendations by level of care on the basis of voting results. RESULTS: The panel voted on 30 statements, five of which were multicomponent statements addressing characteristics specific to PICU level of care including team structure, technology, education and training, academic pursuits, and indications for transfer to tertiary or quaternary PICU. Of the remaining 25 statements, 17 reached consensus cutoff score. Following a review of the Delphi results and consensus, the recommendations were written. CONCLUSIONS: This practice statement and level of care guidance manuscript addresses important specifications for each PICU level of care, including the team structure and resources, technology and equipment, education and training, quality metrics, admission and discharge criteria, and indications for transfer to a higher level of care. The sparse high-quality evidence led the panel to use a modified Delphi process to seek expert opinion to develop consensus-based recommendations where gaps in the evidence exist. Despite this limitation, the members of the Task Force believe that these recommendations will provide guidance to practitioners in making informed decisions regarding pediatric admission or transfer to the appropriate level of care to achieve best outcomes.

Executive Summary: Criteria for Critical Care of Infants and Children: PICU Admission, Discharge, and Triage Practice Statement and Levels of Care Guidance.

This is an executive summary of the 2019 update of the 2004 guidelines and levels of care for PICU. Since previous guidelines, there has been a tremendous transformation of Pediatric Critical Care Medicine with advancements in pediatric cardiovascular medicine, transplant, neurology, trauma, and oncology as well as improvements of care in general PICUs. This has led to the evolution of resources and training in the provision of care through the PICU. Outcome and quality research related to admission, transfer, and discharge criteria as well as literature regarding PICU levels of care to include volume, staffing, and structure were reviewed and included in this statement as appropriate. Consequently, the purposes of this significant update are to address the transformation of the field and codify a revised set of guidelines that will enable hospitals, institutions, and individuals in developing the appropriate PICU for their community needs. The target audiences of the practice statement and guidance are broad and include critical care professionals; pediatricians; pediatric subspecialists; pediatric surgeons; pediatric surgical subspecialists; pediatric imaging physicians; and other members of the patient care team such as nurses, therapists, dieticians, pharmacists, social workers, care coordinators, and hospital administrators who make daily administrative and clinical decisions in all PICU levels of care.

Implementing the ABCDEF Bundle: Top 8 Questions Asked During the ICU Liberation ABCDEF Bundle Improvement Collaborative.

The ABCDEF bundle (A, assess, prevent, and manage pain; B, both spontaneous awakening and spontaneous breathing trials; C, choice of analgesic and sedation; D, delirium: assess, prevent, and manage; E, early mobility and exercise; and F, family engagement and empowerment) improves intensive care unit patient-centered outcomes and promotes interprofessional teamwork and collaboration. The Society of Critical Care Medicine recently completed the ICU Liberation ABCDEF Bundle Improvement Collaborative, a 20-month, multicenter, national quality improvement initiative that formalized dissemination and implementation strategies to promote effective adoption of the ABCDEF bundle. The purpose of this article is to describe 8 of the most frequently asked questions during the Collaborative and to provide practical advice from leading experts to other institutions implementing the ABCDEF bundle.

Common Challenges to Effective ABCDEF Bundle Implementation: The ICU Liberation Campaign Experience.

Although growing evidence supports the safety and effectiveness of the ABCDEF bundle (A, assess, prevent, and manage pain; B, both spontaneous awakening and spontaneous breathing trials; C, choice of analgesic and sedation; D, delirium: assess, prevent, and manage; E, early mobility and exercise; and F, family engagement and empowerment), intensive care unit providers often struggle with how to reliably and consistently incorporate this interprofessional, evidence-based intervention into everyday clinical practice. Recently, the Society of Critical Care Medicine completed the ICU Liberation ABCDEF Bundle Improvement Collaborative, a 20-month, nationwide, multicenter quality improvement initiative that formalized dissemination and implementation strategies and tracked key performance metrics to overcome barriers to ABCDEF bundle adoption. The purpose of this article is to discuss some of the most challenging implementation issues that Collaborative teams experienced, and to provide some practical advice from leading experts on ways to overcome these barriers.

Caring for Critically Ill Patients with the ABCDEF Bundle: Results of the ICU Liberation Collaborative in Over 15,000 Adults.

OBJECTIVE: Decades-old, common ICU practices including deep sedation, immobilization, and limited family access are being challenged. We endeavoured to evaluate the relationship between ABCDEF bundle performance and patient-centered outcomes in critical care. DESIGN: Prospective, multicenter, cohort study from a national quality improvement collaborative. SETTING: 68 academic, community, and federal ICUs collected data during a 20-month period. PATIENTS: 15,226 adults with at least one ICU day. INTERVENTIONS: We defined ABCDEF bundle performance (our main exposure) in two ways: 1) complete performance (patient received every eligible bundle element on any given day) and 2) proportional performance (percentage of eligible bundle elements performed on any given day). We explored the association between complete and proportional ABCDEF bundle performance and three sets of outcomes: patient-related (mortality, ICU and hospital discharge), symptom-related (mechanical ventilation, coma, delirium, pain, restraint use), and system-related (ICU readmission, discharge destination). All models were adjusted for a minimum of 18 a priori determined potential confounders. MEASUREMENTS AND RESULTS: Complete ABCDEF bundle performance was associated with lower likelihood of seven outcomes: hospital death within 7 days (adjusted hazard ratio, 0.32; CI, 0.17-0.62), next-day mechanical ventilation (adjusted odds ratio [AOR], 0.28; CI, 0.22-0.36), coma (AOR, 0.35; CI, 0.22-0.56), delirium (AOR, 0.60; CI, 0.49-0.72), physical restraint use (AOR, 0.37; CI, 0.30-0.46), ICU readmission (AOR, 0.54; CI, 0.37-0.79), and discharge to a facility other than home (AOR, 0.64; CI, 0.51-0.80). There was a consistent dose-response relationship between higher proportional bundle performance and improvements in each of the above-mentioned clinical outcomes (all p < 0.002). Significant pain was more frequently reported as bundle performance proportionally increased (p = 0.0001). CONCLUSIONS: ABCDEF bundle performance showed significant and clinically meaningful improvements in outcomes including survival, mechanical ventilation use, coma, delirium, restraint-free care, ICU readmissions, and post-ICU discharge disposition.

Methodologic Innovation in Creating Clinical Practice Guidelines: Insights From the 2018 Society of Critical Care Medicine Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption Guideline Effort.

OBJECTIVES: To describe novel guideline development strategies created and implemented as part of the Society of Critical Care Medicine's 2018 clinical practice guidelines for pain, agitation (sedation), delirium, immobility (rehabilitation/mobility), and sleep (disruption) in critically ill adults. DESIGN: We involved critical illness survivors from start to finish, used and expanded upon Grading of Recommendations, Assessment, Development and Evaluation methodology for making recommendations, identified evidence gaps, and developed communication strategies to mitigate challenges. SETTING/SUBJECTS: Thirty-two experts from five countries, across five topic-specific sections; four methodologists, two medical librarians, four critical illness survivors, and two Society of Critical Care Medicine support staff. INTERVENTIONS: Unique approaches included the following: 1) critical illness survivor involvement to help ensure patient-centered questions and recommendations; 2) qualitative and semiquantitative approaches for developing descriptive statements; 3) operationalizing a three-step approach to generating final recommendations; and 4) systematic identification of evidence gaps. MEASUREMENTS AND MAIN RESULTS: Critical illness survivors contributed to prioritizing topics, questions, and outcomes, evidence interpretation, recommendation formulation, and article review to ensure that their values and preferences were considered in the guidelines. Qualitative and semiquantitative approaches supported formulating descriptive statements using comprehensive literature reviews, summaries, and large-group discussion. Experts (including the methodologists and guideline chairs) developed and refined guideline recommendations through monthly topic-specific section conference calls. Recommendations were precirculated to all members, presented to, and vetted by, most members at a live meeting. Final electronic voting provided links to all forest plots, evidence summaries, and "evidence to decision" frameworks. Written comments during voting captured dissenting views and were integrated into evidence to decision frameworks and the guideline article. Evidence gaps, reflecting clinical uncertainty in the literature, were identified during the evidence to decision process, live meeting, and voting and formally incorporated into all written recommendation rationales. Frequent scheduled "check-ins" mitigated communication gaps. CONCLUSIONS: Our multifaceted, interdisciplinary approach and novel methodologic strategies can help inform the development of future critical care clinical practice guidelines.

Increasing Evidence-Based Interventions in Patients with Acute Infections in a Resource-Limited Setting: A Before-and-After Feasibility Trial in Gitwe, Rwanda.

OBJECTIVE: To evaluate whether a focused education program and implementation of a treatment bundle increases the rate of early evidence-based interventions in patients with acute infections. DESIGN: Single-center, prospective, before-and-after feasibility trial. SETTING: Emergency department of a sub-Saharan African district hospital. PATIENTS: Patients > 28 days of life admitted to the study hospital for an acute infection. INTERVENTIONS: The trial had three phases (each of four months). Interventions took place during the second (educational program followed by implementation of the treatment bundle) and third (provision of resources to implement treatment bundle) phases. MEASUREMENTS AND MAIN RESULTS: Demographic, clinical, and laboratory data were collected at study enrollment; 24, 48, and 72 hours after hospital admission; and at discharge. A total of 1,594 patients were enrolled (pre-intervention, n = 661; intervention I, n = 531; intervention II, n = 402). The rate of early evidence-based interventions per patient during Intervention Phase I was greater than during the pre-intervention phase (74 ± 17 vs. 79 ± 15%, p < 0.001). No difference was detected when data were compared between Intervention Phases I and II (79 ± 15 vs. 80 ± 15%, p = 0.58). No differences in the incidence of blood transfusion (pre-intervention, 6%; intervention I, 7%; intervention II, 7%) or severe adverse events in the first 24 hours (allergic reactions: pre-intervention, 0.2%; intervention I, 0%; intervention II, 0%; respiratory failure: pre-intervention, 2%; intervention I, 2%; intervention II, 2%; acute renal failure: pre-intervention, 2%; intervention I, 2%; intervention II, 1%) were observed. CONCLUSIONS: Our results indicate that a focused education program and implementation of an infection treatment bundle in clinical practice increased the rate of early evidence-based interventions in patients with acute infections (mostly malaria) admitted to a sub-Saharan African district hospital. Provision of material resources did not further increase this rate. While no safety issues were detected, this could be related to the very low disease severity of the enrolled patient population (www.clinicaltrials.gov: NCT02697513).

Increasing evidence-based interventions in patients with acute infections in a resource-limited setting: a before-and-after feasibility trial in Gitwe, Rwanda.

OBJECTIVE: To evaluate whether a focused education program and implementation of a treatment bundle increases the rate of early evidence-based interventions in patients with acute infections. DESIGN: Single-center, prospective, before-and-after feasibility trial. SETTING: Emergency department of a sub-Saharan African district hospital. PATIENTS: Patients > 28 days of life admitted to the study hospital for an acute infection. INTERVENTIONS: The trial had three phases (each of 4 months). Interventions took place during the second (educational program followed by implementation of the treatment bundle) and third (provision of resources to implement treatment bundle) phases. MEASUREMENTS AND MAIN RESULTS: Demographic, clinical, and laboratory data were collected at study enrollment; 24, 48, and 72 h after hospital admission; and at discharge. A total of 1594 patients were enrolled (pre-intervention, n = 661; intervention I, n = 531; intervention II, n = 402). The rate of early evidence-based interventions per patient during Intervention Phase I was greater than during the pre-intervention phase (74 ± 17 vs. 79 ± 15%, p < 0.001). No difference was detected when data were compared between Intervention Phases I and II (79 ± 15 vs. 80 ± 15%, p = 0.58). No differences in the incidence of blood transfusion (pre-intervention, 6%; intervention I, 7%; intervention II, 7%) or severe adverse events in the first 24 h (allergic reactions: pre-intervention, 0.2%; intervention I, 0%; intervention II, 0%; respiratory failure: pre-intervention, 2%; intervention I, 2%; intervention II, 2%; acute renal failure: pre-intervention, 2%; intervention I, 2%; intervention II, 1%) were observed. CONCLUSIONS: Our results indicate that a focused education program and implementation of an infection treatment bundle in clinical practice increased the rate of early evidence-based interventions in patients with acute infections (mostly malaria) admitted to a sub-Saharan African district hospital. Provision of material resources did not further increase this rate. While no safety issues were detected, this could be related to the very low disease severity of the enrolled patient population ( http://www.clinicaltrials.gov : NCT02697513).