Benefit-Risk Assessment of mRNA COVID-19 Vaccines in Children Aged 6 Months to 4 Years in the Omicron Era.

BACKGROUND: There is no risk and benefit assessment of COVID-19 vaccination for children younger than 5 years using a single health outcomes scale. The objective of this study is to compare the expected risk and benefits of the mRNA primary series of COVID-19 vaccines for children aged 6 months to 4 years in the United States using a single health outcome scale in the Omicron era. METHODS: The expected benefits and risks of the primary two-dose series of mRNA COVID-19 vaccines for children aged 6 months to 4 years were stratified by sex, the presence of underlying medical conditions, the presence of infection-induced immunity, and the type of mRNA vaccine (BNT162b2 or mRNA-1273). A scoping literature review was conducted to identify the indicators in the decision tree model. The benefit-risk ratio was the outcome of interest. RESULTS: The benefit-risk ratios ranged from 200.4 in BNT162b2 for males aged 6-11 months with underlying medical conditions and without infection-induced immunity to 3.2 in mRNA-1273 for females aged 1-4 years without underlying medical conditions and with infection-induced immunity. CONCLUSIONS: The expected benefit of receiving the primary series of mRNA vaccines outweighed the risk among children ages 6 months to 4 years regardless of sex, presence of underlying medical conditions, presence of infection-induced immunity, or type of mRNA vaccines. However, the continuous monitoring of the COVID-19 epidemiology as well as vaccine effectiveness and safety is important.

Designing Practical Motivational Interviewing Training for Mental Health Practitioners Implementing Behavioral Lifestyle Interventions: Protocol for 3 Pilot Intervention Studies.

BACKGROUND: Motivational interviewing (MI) is an evidence-based, patient-centered communication method shown to be effective in helping persons with serious mental illness (SMI) to improve health behaviors. In clinical trials where study staff conducted lifestyle interventions incorporating an MI approach, cardiovascular disease (CVD) risk profiles of participants with SMI showed improvement. Given the disproportionate burden of CVD in this population, practitioners who provide somatic and mental health care to persons with SMI are ideally positioned to deliver patient-centered CVD risk reduction interventions. However, the time for MI training (traditionally 16-24 hours), follow-up feedback, and the coaching required to develop and maintain patient-centered skills are significant barriers to incorporating MI when scaling up these evidence-based practices. OBJECTIVE: We describe the design and development of the following 2 scalable MI training approaches for community mental health practitioners: real-time brief workshops and follow-up asynchronous avatar training. These approaches are being used in 3 different pilot implementation research projects that address weight loss, smoking cessation, and CVD risk reduction in people with SMI who are a part of ALACRITY Center, a research-to-practice translation center funded by the National Institute of Mental Health. METHODS: Clinicians and staff in community mental health clinics across Maryland were trained to deliver 3 distinct evidence-based physical health lifestyle interventions using an MI approach to persons with SMI. The real-time brief MI workshop training for ACHIEVE-D weight loss coaches was 4 hours; IMPACT smoking cessation counselors received 2-hour workshops and prescribers received 1-hour workshops; and RHYTHM CVD risk reduction program staff received 4 hours of MI. All workshop trainings occurred over videoconference. The asynchronous avatar training includes 1 common didactic instructional module for the 3 projects and 1 conversation simulation unique to each study's target behavior. Avatar training is accessible on a commercial website. We plan to assess practitioners' attitudes and beliefs about MI and evaluate the impact of the 2 MI training approaches on their MI skills 3, 6, and 12 months after training using the MI Treatment Integrity 4.2.1 coding tool and the data generated by the avatar-automated scoring system. RESULTS: The ALACRITY Center was funded in August 2018. We have implemented the MI training for 126 practitioners who are currently delivering the 3 implementation projects. We expect the studies to be complete in May 2023. CONCLUSIONS: This study will contribute to knowledge about the effect of brief real-time training augmented with avatar skills practice on clinician MI skills. If MI Treatment Integrity scoring shows it to be effective, brief videoconference trainings supplemented with avatar skills practice could be used to train busy community mental health practitioners to use an MI approach when implementing physical health interventions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44830.

Risk and Benefit of mRNA COVID-19 Vaccines for the Omicron Variant by Age, Sex, and Presence of Comorbidity: A Quality-Adjusted Life Years Analysis.

The development of the mutant omicron variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the coronavirus disease 2019 (COVID-19) pandemic raised the importance of reevaluating the risk and benefit of COVID-19 vaccines. With a decision tree model, we calculated the benefit-risk ratio and the benefit-risk difference of receiving monovalent messenger RNA (mRNA) COVID-19 vaccine (primary 2 doses, a third dose, and a fourth dose) in the 4-5 months after vaccination using quality-adjusted life years. The analysis was stratified by age, sex, and the presence of comorbidity. Evidence from peer-reviewed publications and gray literature was reviewed on September 16, 2022, to inform the study. Benefit-risk ratios for receipt of the BNT162b2 vaccine (Pfizer-BioNTech) ranged from 6.8 for males aged 12-17 years without comorbidity for the primary doses to 221.3 for females aged ≥65 years with comorbidity for the third dose. The benefit-risk ratios for receipt of the mRNA-1273 vaccine (Moderna) ranged from 7.2 for males aged 18-29 years without comorbidity for the primary doses to 101.4 for females aged ≥65 years with comorbidity for the third dose. In all scenarios of the one-way sensitivity analysis, the benefit-risk ratios were more than 1, irrespective of age, sex, comorbidity status, and type of vaccine, for both primary and booster doses. The benefits of mRNA COVID-19 vaccines in protecting against the omicron variant outweigh the risks, irrespective of age, sex, and comorbidity.

Crosstalk between CD4+ T Cells and Airway Smooth Muscle in Pediatric Obesity-related Asthma.

Rationale: Pediatric obesity-related asthma is a nonatopic asthma phenotype with high disease burden and few effective therapies. RhoGTPase upregulation in peripheral blood T helper (Th) cells is associated with the phenotype, but the mechanisms that underlie this association are not known. Objectives: To investigate the mechanisms by which upregulation of CDC42 (Cell Division Cycle 42), a RhoGTPase, in Th cells is associated with airway smooth muscle (ASM) biology. Methods: Chemotaxis of obese asthma and healthy-weight asthma Th cells, and their adhesion to obese and healthy-weight nonasthmatic ASM, was investigated. Transcriptomics and proteomics were used to determine the differential effect of obese and healthy-weight asthma Th cell adhesion to obese or healthy-weight ASM biology. Measurements and Main Results: Chemotaxis of obese asthma Th cells with CDC42 upregulation was resistant to CDC42 inhibition. Obese asthma Th cells were more adherent to obese ASM compared with healthy-weight asthma Th cells to healthy-weight ASM. Compared with coculture with healthy-weight ASM, obese asthma Th cell coculture with obese ASM was positively enriched for genes and proteins involved in actin cytoskeleton organization, transmembrane receptor protein kinase signaling, and cell mitosis, and negatively enriched for extracellular matrix organization. Targeted gene evaluation revealed upregulation of IFNG, TNF (tumor necrosis factor), and Cluster of Differentiation 247 (CD247) among Th cell genes, and of Ak strain transforming (AKT), Ras homolog family member A (RHOA), and CD38, with downregulation of PRKCA (Protein kinase C-alpha), among smooth muscle genes. Conclusions: Obese asthma Th cells have uninhibited chemotaxis and are more adherent to obese ASM, which is associated with upregulation of genes and proteins associated with smooth muscle proliferation and reciprocal nonatopic Th cell activation.

Scaling Evidence-Based Interventions to Improve the Cardiovascular Health of People With Serious Mental Illness.

People with serious mental illnesses (SMIs) experience excess mortality, driven in large part by high rates of cardiovascular disease (CVD), with all cardiovascular disease risk factors elevated. Interventions designed to improve the cardiovascular health of people with SMI have been shown to lead to clinically significant improvements in clinical trials; however, the uptake of these interventions into real-life clinical settings remains limited. Implementation strategies, which constitute the "how to" component of changing healthcare practice, are critical to supporting the scale-up of evidence-based interventions that can improve the cardiovascular health of people with SMI. And yet, implementation strategies are often poorly described and rarely justified theoretically in the literature, limiting the ability of researchers and practitioners to tease apart why, what, how, and when implementation strategies lead to improvement. In this Perspective, we describe the implementation strategies that the Johns Hopkins ALACRITY Center for Health and Longevity in Mental Illness is using to scale-up three evidenced-based interventions related to: (1) weight loss; (2) tobacco smoking cessation treatment; and (3) hypertension, dyslipidemia, and diabetes care for people with SMI. Building on concepts from the literature on complex health interventions, we focus on considerations related to the core function of an intervention (i.e., or basic purposes of the change process that the health intervention seeks to facilitate) vs. the form (i.e., implementation strategies or specific activities taken to carry out core functions that are customized to local contexts). By clearly delineating how implementation strategies are operationalized to support the interventions' core functions across these three studies, we aim to build and improve the future evidence base of how to adapt, implement, and evaluate interventions to improve the cardiovascular health of people with SMI.

Reducing Three Infections Across Cardiac Surgery Programs: A Multisite Cross-Unit Collaboration.

Using a pre-post design, this study examined the impact of a multifaceted program to simultaneously improve 3 health care-associated infections and patient safety culture throughout the cardiac surgery service line in 11 hospitals. Interventions included the Comprehensive Unit-based Safety Program to improve safety culture and evidence-based bundles to prevent central line-associated bloodstream infection (CLABSI), surgical site infection (SSI), and ventilator-associated pneumonia (VAP). CLABSIs and SSIs showed a downward trend over 2 years, then the rates returned to levels similar to baseline in the third year. VAP rate changes were difficult to interpret because of the VAP definition change. Patient safety culture domain "hospital management support" showed significant improvement, but feedback and communication about errors and staffing declined. Simultaneous implementation of multiple interventions across units is challenging. The findings highlight the importance of sustainment efforts and suggest future work should anticipate both positive and negative change in safety culture dimensions.

Using a society database to evaluate a patient safety collaborative: the Cardiovascular Surgical Translational Study.

AIM: To assess the utility of using external databases for quality improvement (QI) evaluations in the context of an innovative QI collaborative aimed to reduce three infections and improve patient safety across the cardiac surgery service line. METHODS: We compared changes in each outcome between 15 intervention hospitals (infection reduction protocols plus safety culture intervention) and 52 propensity score-matched hospitals (feedback only). RESULTS: Improvement trends in several outcomes among the intervention hospitals were not statistically different from those in comparison hospitals. CONCLUSION: Using external databases such as those of professional societies may permit comparative effectiveness assessment by providing concurrent comparison groups, additional outcome measures and longer follow-up. This can better inform evaluation of continuous QI in healthcare organizations.

Patient, Provider, and System Factors Contributing to Patient Safety Events During Medical and Surgical Hospitalizations for Persons With Serious Mental Illness.

This study aimed to explore patient-, provider-, and system-level factors that may contribute to elevated risk of patient safety events among persons with serious mental illness (SMI). We conducted a medical record review of medical/surgical admissions in Maryland hospitals from 1994 to 2004 for a community-based sample of adults with SMI (N = 790 hospitalizations). We estimated the prevalence of multiple patient, provider, and system factors that could influence patient safety among persons with SMI. We conducted a case crossover analysis to examine the relationship between these factors and adverse patient safety events. Patients' mental status, level of consciousness, disease severity, and providers' lack of patient monitoring, delay/failure to seek consultation, lack of trainee supervision, and delays in care were positively associated with adverse patient safety events (p < 0.05). Efforts to reduce SMI-related patient safety risks will need to be multifaceted and address both patient- and provider-level factors.

Two-State Collaborative Study of a Multifaceted Intervention to Decrease Ventilator-Associated Events.

OBJECTIVES: Ventilator-associated events are associated with increased mortality, prolonged mechanical ventilation, and longer ICU stay. Given strong national interest in improving ventilated patient care, the National Institute of Health and Agency for Healthcare Research and Quality funded a two-state collaborative to reduce ventilator-associated events. We describe the collaborative's impact on ventilator-associated event rates in 56 ICUs. DESIGN: Longitudinal quasi-experimental study. SETTING: Fifty-six ICUs at 38 hospitals in Maryland and Pennsylvania from October 2012 to March 2015. INTERVENTIONS: We organized a multifaceted intervention to improve adherence with evidence-based practices, unit teamwork, and safety culture. Evidence-based interventions promoted by the collaborative included head-of-bed elevation, use of subglottic secretion drainage endotracheal tubes, oral care, chlorhexidine mouth care, and daily spontaneous awakening and breathing trials. Each unit established a multidisciplinary quality improvement team. We coached teams to establish comprehensive unit-based safety programs through monthly teleconferences. Data were collected on rounds using a common tool and entered into a Web-based portal. MEASUREMENTS AND RESULTS: ICUs reported 69,417 ventilated patient-days of intervention compliance observations and 1,022 unit-months of ventilator-associated event data. Compliance with all evidence-based interventions improved over the course of the collaborative. The quarterly mean ventilator-associated event rate significantly decreased from 7.34 to 4.58 cases per 1,000 ventilator-days after 24 months of implementation (p = 0.007). During the same time period, infection-related ventilator-associated complication and possible and probable ventilator-associated pneumonia rates decreased from 3.15 to 1.56 and 1.41 to 0.31 cases per 1,000 ventilator-days (p = 0.018, p = 0.012), respectively. CONCLUSIONS: A multifaceted intervention was associated with improved compliance with evidence-based interventions and decreases in ventilator-associated event, infection-related ventilator-associated complication, and probable ventilator-associated pneumonia. Our study is the largest to date affirming that best practices can prevent ventilator-associated events.

Reducing preventable harm: observations on minimizing bloodstream infections.

Purpose The purpose of this paper is to provide a practical framework that health care organizations could use to decrease preventable healthcare-acquired harms. Design/methodology/approach An existing theory of how hospitals succeeded in reducing rates of central line-associated bloodstream infections was refined, drawing from the literature and experiences in facilitating improvement efforts in thousands of hospitals in and outside the USA. Findings The following common interventions were implemented by hospitals able to reduce and sustain low infection rates. Hospital and intensive care unit (ICU) leaders demonstrated and vocalized their commitment to the goal of zero preventable harm. Also, leaders created an enabling infrastructure in the way of a coordinating team to support the improvement work to prevent infections. The team of hospital quality improvement and infection prevention staff provided project management, analytics, improvement science support, and expertise on evidence-based infection prevention practices. A third intervention assembled Comprehensive Unit-based Safety Program teams in ICUs to foster local ownership of the improvement work. The coordinating team also linked unit-based safety teams in and across hospital organizations to form clinical communities to share information and disseminate effective solutions. Practical implications This framework is a feasible approach to drive local efforts to reduce bloodstream infections and other preventable healthcare-acquired harms. Originality/value Implementing this framework could decrease the significant morbidity, mortality, and costs associated with preventable harms.

CLABSI Conversations: Lessons From Peer-to-Peer Assessments to Reduce Central Line-Associated Bloodstream Infections.

A national collaborative helped many hospitals dramatically reduce central line-associated bloodstream infections (CLABSIs), but some hospitals struggled to reduce infection rates. This article describes the development of a peer-to-peer assessment process (CLABSI Conversations) and the practical, actionable practices we discovered that helped intensive care unit teams achieve a CLABSI rate of less than 1 infection per 1000 catheter-days for at least 1 year. CLABSI Conversations was designed as a learning-oriented process, in which a team of peers visited hospitals to surface barriers to infection prevention and to share best practices and insights from successful intensive care units. Common practices led to 10 recommendations: executive and board leaders communicate the goal of zero CLABSI throughout the hospital; senior and unit-level leaders hold themselves accountable for CLABSI rates; unit physicians and nurse leaders own the problem; clinical leaders and infection preventionists build infection prevention training and simulation programs; infection preventionists participate in unit-based CLABSI reduction efforts; hospital managers make compliance with best practices easy; clinical leaders standardize the hospital's catheter insertion and maintenance practices and empower nurses to stop any potentially harmful acts; unit leaders and infection preventionists investigate CLABSIs to identify root causes; and unit nurses and staff audit catheter maintenance policies and practices.

Safety Culture in Cardiac Surgical Teams: Data From Five Programs and National Surgical Comparison.

BACKGROUND: Little is known about safety culture in the area of cardiac surgery as compared with other types of surgery. The unique features of cardiac surgical teams may result in different perceptions of patient safety and patient safety culture. METHODS: We measured and described safety culture in five cardiovascular surgical centers using the Hospital Survey on Patient Safety Culture, and compared the data with the Agency for Healthcare Research and Quality (AHRQ) 2010 comparative database in surgery and anesthesiology (all types). We reported mean scores, standard deviations, and percent positive responses for the two single-item measures and 12 patient safety climate dimensions in the Hospital Survey on Patient Safety Culture. RESULTS: In the five cardiac surgical programs, the dimension of teamwork within hospital units had the highest positive score (74% positive responses), and the dimension of nonpunitive response to error had the lowest score (38% positive responses). Surgeons and support staff perceived better safety climate than nurses, perfusionists, and anesthesia practitioners. The cardiac surgery cohort reported more positive safety climate than the AHRQ all-type surgery cohort in four dimensions but lower frequency of reporting mistakes. The cardiac anesthesiology cohort scored lower on two dimensions compared with the AHRQ all-type anesthesiology cohort. CONCLUSIONS: This study identifies patient safety areas for improvement in cardiac surgical teams in comparison with all-type surgical teams. We also found that different professional disciplines in cardiac surgical teams perceive patient safety differently.

Towards expanding the acute care team: Learning how to involve families in care processes.

INTRODUCTION: Effective teamwork is known to be important to improving health care outcomes. Current research often highlights teamwork among health care professionals without consideration of approaches to including family as part of the health care team. In this study, the authors assess family and provider openness to expanding the care team to include family participation and introduce the Family Involvement Menu as a tool to facilitate family engagement. METHOD: They collected 37 family surveys and 37 clinician surveys to understand the perception, comfort level, experience, and interest of family and clinicians in including family in the care of the patient. The majority of family reported being interested and comfortable in participating in care (95% and 92%, respectively). RESULTS: The majority of clinicians considered family already to be part of the health care team (92%) though only 16% reported routinely inviting families to participate in direct patient care all the time. Multiple direct patient care activities were identified as promising opportunities for family engagement. Barriers to family engagement reported included the family being scared (19%), uncomfortable (19%), or unwilling (14%) or nurses not having enough time (14%) to involve families. DISCUSSION: Engaging family has the potential to increase nursing availability for other tasks, enhance relationship building, and is an opportunity to introduce early education for family, better preparing them for transition of care and discharge. The Family Involvement Menu supports family engagement and can be a strategy to include family members as part of the health care team.

Locating Errors Through Networked Surveillance: A Multimethod Approach to Peer Assessment, Hazard Identification, and Prioritization of Patient Safety Efforts in Cardiac Surgery.

OBJECTIVES: The objectives were to develop a scientifically sound and feasible peer-to-peer assessment model that allows health-care organizations to evaluate patient safety in cardiovascular operating rooms and to establish safety priorities for improvement. METHODS: The locating errors through networked surveillance study was conducted to identify hazards in cardiac surgical care. A multidisciplinary team, composed of organizational sociology, organizational psychology, applied social psychology, clinical medicine, human factors engineering, and health services researchers, conducted the study. We used a transdisciplinary approach, which integrated the theories, concepts, and methods from each discipline, to develop comprehensive research methods. Multiple data collection was involved: focused literature review of cardiac surgery-related adverse events, retrospective analysis of cardiovascular events from a national database in the United Kingdom, and prospective peer assessment at 5 sites, involving survey assessments, structured interviews, direct observations, and contextual inquiries. A nominal group methodology, where one single group acts to problem solve and make decisions was used to review the data and develop a list of the top priority hazards. RESULTS: The top 6 priority hazard themes were as follows: safety culture, teamwork and communication, infection prevention, transitions of care, failure to adhere to practices or policies, and operating room layout and equipment. CONCLUSIONS: We integrated the theories and methods of a diverse group of researchers to identify a broad range of hazards and good clinical practices within the cardiovascular surgical operating room. Our findings were the basis for a plan to prioritize improvements in cardiac surgical care. These study methods allowed for the comprehensive assessment of a high-risk clinical setting that may translate to other clinical settings.

Evaluation of a hospital admission prediction model adding coded chief complaint data using neural network methodology.

OBJECTIVE: Our objective was to apply neural network methodology to determine whether adding coded chief complaint (CCC) data to triage information would result in an improved hospital admission prediction model than one without CCC data. PARTICIPANTS AND METHODS: We carried out a retrospective derivation and validation cohort study of all adult emergency department visits to a single center. We downloaded triage, chief complaint, and admission/discharge data on each included visit. Using a CCC algorithm and the Levenberg-Marquardt back-propagation learning method, we derived hospital admission prediction models without and with CCC data and applied these to the validation cohort, reporting the prediction models' characteristics. RESULTS: A total of 74 056 emergency department visits were included in the derivation cohort, 85 144 in the validation cohort with 213 CCC categories. The sensitivity/specificity of the derivation cohort models without and with CCC data were 64.0% [95% confidence interval (CI): 63.7-64.3], 87.7% (95% CI: 87.4-88.0), 59.8% (95% CI: 59.5-60.3%), and 91.7% (95% CI: 91.4-92.0) respectively. The sensitivity/specificity of the derived models without and with CCC data applied to the validation cohort were 60.7% (95% CI: 60.4-61.0), 87.7% (95% CI: 87.4-88.0), 59.8% (95% CI: 59.5-60.3), and 90.6% (95% CI: 90.3-90.9) respectively. The area under the curve in the validation cohort for the derived models without and with CCC data were 0.840 (95% CI: 0.838-0.842) and 0.860 (95% CI: 0.858-0.862). Net reclassification index (0.156; 95% CI: 0.148-0.163) and integrated discrimination improvement (0.060; 95% CI: 0.058-0.061) in the CCC model were significant. CONCLUSION: Neural net methodology application resulted in the derivation and validation of a modestly stronger hospital admission prediction model after the addition of CCC data.

A systematic review of teamwork in the intensive care unit: what do we know about teamwork, team tasks, and improvement strategies?

PURPOSE: Teamwork is essential for ensuring the quality and safety of health care delivery in the intensive care unit (ICU). This article addresses what we know about teamwork, team tasks, and team improvement strategies in the ICU to identify the strengths and limitations of the existing knowledge base to guide future research. METHODS: A keyword search of the PubMed database was conducted in February 2013. Keyword combinations focused on 3 areas: (1) teamwork, (2) the ICU, and (3) training/quality improvement interventions. All studies that investigated teamwork, team tasks, or team interventions within the ICU (ie, intradepartment) were selected for inclusion. RESULTS: Teamwork has been investigated across an array of research contexts and task types. The terminology used to describe team factors varied considerably across studies. The most common team tasks involved strategy and goal formulation. Team training and structured protocols were the most widely implemented quality improvement strategies. CONCLUSIONS: Team research is burgeoning in the ICU, yet low-hanging fruit remains that can further advance the science of teams in the ICU if addressed. Constructs must be defined, and theoretical frameworks should be referenced. The functional characteristics of tasks should also be reported to help determine the extent to which study results might generalize to other contexts of work.

Eliminating central line-associated bloodstream infections: a national patient safety imperative.

BACKGROUND: Several studies demonstrating that central line-associated bloodstream infections (CLABSIs) are preventable prompted a national initiative to reduce the incidence of these infections. METHODS: We conducted a collaborative cohort study to evaluate the impact of the national "On the CUSP: Stop BSI" program on CLABSI rates among participating adult intensive care units (ICUs). The program goal was to achieve a unit-level mean CLABSI rate of less than 1 case per 1,000 catheter-days using standardized definitions from the National Healthcare Safety Network. Multilevel Poisson regression modeling compared infection rates before, during, and up to 18 months after the intervention was implemented. RESULTS: A total of 1,071 ICUs from 44 states, the District of Columbia, and Puerto Rico, reporting 27,153 ICU-months and 4,454,324 catheter-days of data, were included in the analysis. The overall mean CLABSI rate significantly decreased from 1.96 cases per 1,000 catheter-days at baseline to 1.15 at 16-18 months after implementation. CLABSI rates decreased during all observation periods compared with baseline, with adjusted incidence rate ratios steadily decreasing to 0.57 (95% confidence intervals, 0.50-0.65) at 16-18 months after implementation. CONCLUSION: Coincident with the implementation of the national "On the CUSP: Stop BSI" program was a significant and sustained decrease in CLABSIs among a large and diverse cohort of ICUs, demonstrating an overall 43% decrease and suggesting the majority of ICUs in the United States can achieve additional reductions in CLABSI rates.

A multicenter, phased, cluster-randomized controlled trial to reduce central line-associated bloodstream infections in intensive care units*.

OBJECTIVES: To determine the causal effects of an intervention proven effective in pre-post studies in reducing central line-associated bloodstream infections in the intensive care unit. DESIGN: We conducted a multicenter, phased, cluster-randomized controlled trial in which hospitals were randomized into two groups. The intervention group started in March 2007 and the control group started in October 2007; the study period ended September 2008. Baseline data for both groups are from 2006. SETTING: Forty-five intensive care units from 35 hospitals in two Adventist healthcare systems. INTERVENTIONS: A multifaceted intervention involving evidence-based practices to prevent central line-associated bloodstream infections and the Comprehensive Unit-based Safety Program to improve safety, teamwork, and communication. MEASUREMENTS AND RESULTS: We measured central line-associated bloodstream infections per 1,000 central line days and reported quarterly rates. Baseline average central line-associated bloodstream infections per 1,000 central line days was 4.48 and 2.71, for the intervention and control groups (p = .28), respectively. By October to December 2007, the infection rate declined to 1.33 in the intervention group compared to 2.16 in the control group (adjusted incidence rate ratio 0.19; p = .003; 95% confidence interval 0.06-0.57). The intervention group sustained rates <1/1,000 central line days at 19 months (an 81% reduction). The control group also reduced infection rates to <1/1,000 central line days (a 69% reduction) at 12 months. CONCLUSIONS: This study demonstrated a causal relationship between the multifaceted intervention and the reduced central line-associated bloodstream infections. Both groups decreased infection rates after implementation and sustained these results over time, replicating the results found in previous, pre-post studies of this multifaceted intervention and providing further evidence that most central line-associated bloodstream infections are preventable.