The RICH LIFE Project: A cluster randomized pragmatic trial comparing the effectiveness of health system only vs. health system Plus a collaborative/stepped care intervention to reduce hypertension disparities.

Disparities in the control of hypertension and other cardiovascular disease risk factors are well-documented in the United States, even among patients seen regularly in the healthcare system. Few existing approaches explicitly address disparities in hypertension care and control. This paper describes the RICH LIFE Project (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) design. METHODS: RICH LIFE is a two-arm, cluster-randomized trial, comparing the effectiveness of enhanced standard of care, "Standard of Care Plus" (SCP), to a multi-level intervention, "Collaborative Care/Stepped Care" (CC/SC), for improving blood pressure (BP) control and patient activation and reducing disparities in BP control among 1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates; and quarterly webinars in management practices, quality improvement and disparities reduction. Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults). The primary clinical outcome is BP control (<140/90 mm Hg) at 12 months. The primary patient-reported outcome is change from baseline in self-reported patient activation at 12 months. DISCUSSION: This study will provide knowledge about the feasibility of leveraging existing resources in routine primary care and potential benefits of adding supportive community-facing roles to improve hypertension care and reduce disparities. TRIAL REGISTRATION: Clinicaltrials.govNCT02674464.

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.

Technologies in the wild (TiW): human factors implications for patient safety in the cardiovascular operating room.

We describe different sources of hazards from cardiovascular operating room (CVOR) technologies, how hazards propagate in the CVOR and their impact on cognitive processes. Previous studies have examined hazards from poor design of a specific CVOR technology. However, the impact of different CVOR technologies functioning in context is not clearly understood. In addition, the impact of non-design hazards in technology devices is unclear. Our study identified hazards from organisational, physical/environmental elements, in addition to design of technology in a CVOR. We used observations, follow-up interviews and photographs. With qualitative analyses, we categorised the different hazard sources and their potential impact on cognitive processes. Patient safety can be built into technologies by incorporating user needs in design, decision-making and implementation of medical technologies. PRACTITIONER SUMMARY: Effective design and implementation of technology in a safety-critical system requires prospective understanding of technology-related hazards. Our research fills this gap by studying different technologies in context of a CVOR using observations. Qualitative analyses identified different sources for technology-related hazards besides design, and their impact on cognitive processes.

Republished: development and evaluation of a 3-day patient safety curriculum to advance knowledge, self-efficacy and system thinking among medical students.

PURPOSE: To develop a patient safety curriculum and evaluate its impact on medical students' safety knowledge, self-efficacy and system thinking. METHODS: This study reports on curriculum development and evaluation of a 3-day, clinically oriented patient safety intersession that was implemented at the Johns Hopkins School of Medicine in January 2011. Using simulation, skills demonstrations, small group exercises and case studies, this intersession focuses on improving students' teamwork and communication skills and system-based thinking while teaching on the causes of preventable harm and evidence-based strategies for harm prevention. One hundred and twenty students participated in this intersession as part of their required second year curriculum. A pre-post assessment of students' safety knowledge, self-efficacy in safety skills and system-based thinking was conducted. Student satisfaction data were also collected. RESULTS: Students' safety knowledge scores significantly improved (mean +19% points; 95% CI 17.0 to 21.6; p<0.01). Composite system thinking scores increased from a mean pre-intersession score of 60.1 to a post-intersession score of 67.6 (p<0.01). Students had statistically significant increases in self-efficacy for all taught communication and safety skills. Participant satisfaction with the intersession was high. CONCLUSIONS: The patient safety intersession resulted in increased knowledge, system-based thinking, and self-efficacy scores among students. Similar intersessions can be implemented at medical, nursing, pharmacy and other allied health schools separately or jointly as part of required school curricula. Further study of the long-term impact of such education on knowledge, skills, attitudes and behaviours of students is warranted.

Using the Opportunity Estimator tool to improve engagement in a quality and safety intervention.

Teams throughout the United States participating in a program to reduce central line-associated bloodstream infections (CLABSIs) are using the Opportunity Estimator. This web-based tool translates CLABSI-related data into "opportunity estimates" of the patient lives and money that could be saved by reducing these infections.

Review article: high stakes and high risk: a focused qualitative review of hazards during cardiac surgery.

Cardiac surgery is a high-risk procedure performed by a multidisciplinary team using complex tools and technologies. Efforts to improve cardiac surgery safety have been ongoing for more than a decade, yet the literature provides little guidance regarding best practices for identifying errors and improving patient safety. This focused review of the literature was undertaken as part of the FOCUS initiative (Flawless Operative Cardiovascular Unified Systems), a multifaceted effort supported by the Society of Cardiovascular Anesthesiologists Foundation to identify hazards and develop evidence-based protocols to improve cardiac surgery safety. Hazards were defined as anything that posed a potential or real risk to the patient, including errors, near misses, and adverse events. Of the 1438 articles identified for title review, 390 underwent full abstract screening, and 69 underwent full article review, which in turn yielded 55 meeting the inclusion criteria for this review. Two key themes emerged. First, studies were predominantly reactive (responding to an event or report) instead of proactive (using prospective designs such as self-assessments and external reviewers, etc.) and very few tested interventions. Second, minor events were predictive of major problems: multiple, often minor, deviations from normal procedures caused a cascade effect, resulting in major distractions that ultimately led to major events. This review fills an important gap in the literature on cardiac surgery safety, that of systematically identifying and categorizing known hazards according to their primary systemic contributor (or contributors). We conclude with recommendations for improving patient outcomes by building a culture of safety, promoting transparency, standardizing training, increasing teamwork, and monitoring performance. Finally, there is an urgent need for studies that evaluate interventions to mitigate the inherent risks of cardiac surgery.

Using evidence, rigorous measurement, and collaboration to eliminate central catheter-associated bloodstream infections.

Healthcare-associated infections are common, costly, and often lethal. Although there is growing pressure to reduce these infections, one project thus far has unprecedented collaboration among many groups at every level of health care. After this project produced a 66% reduction in central catheter-associated bloodstream infections and a median central catheter-associated bloodstream infection rate of zero across >100 intensive care units in Michigan, the Agency for Healthcare Research and Quality awarded a grant to spread this project to ten additional states. A program, called On the CUSP: Stop BSI, was formulated from the Michigan project, and additional funding from the Agency for Healthcare Research and Quality and private philanthropy has positioned the program for implementation state by state across the United States. Furthermore, the program is being implemented throughout Spain and England and is undergoing pilot testing in several hospitals in Peru. The model in this program balances the tension between being scientifically rigorous and feasible. The three main components of the model include translating evidence into practice at the bedside to prevent central catheter-associated bloodstream infections, improving culture and teamwork, and having a data collection system to monitor central catheter-associated bloodstream infections and other variables. If successful, this program will be the first national quality improvement program in the United States with quantifiable and measurable goals.

Improving the quality of quality improvement projects.

As the stakes grow for evaluating the quality of health care delivery, so too should greater attention be paid to the integrity of the design, conduct, and inferences made from QI projects. QI projects that seek to make inferences, especially public inferences, about the impact of an intervention to improve quality of care should be rigorously designed and evaluated, and limitations and potential biases transparently reported to understand how they may affect the conclusions suggested by the project. Our patients deserve nothing less.

Improving patient safety in intensive care units in Michigan.

PURPOSE: The aim of this study was to describe the design and lessons learned from implementing a large-scale patient safety collaborative and the impact of an intervention on teamwork climate in intensive care units (ICUs) across the state of Michigan. MATERIALS AND METHODS: This study used a collaborative model for improvement involving researchers from the Johns Hopkins University and Michigan Health and Hospital Association. A quality improvement team in each ICU collected and submitted baseline data and implemented quality improvement interventions. Primary outcome measures were improvements in safety culture scores using the Teamwork Climate Scale of the Safety Attitudes Questionnaire (SAQ); 99 ICUs provided baseline SAQ data. Baseline performance for adherence to evidence-based interventions for ventilated patients is also reported. The intervention to improve safety culture was the comprehensive unit-based safety program. The rwg statistic measures the extent to which there is a group consensus. RESULTS: Overall response rate for the baseline SAQ was 72%. Statistical tests confirmed that teamwork climate scores provided a valid measure of teamwork climate consensus among caregivers in an ICU, mean rwg was 0.840 (SD = 0.07). Teamwork climate varied significantly among ICUs at baseline (F98, 5325 = 5.90, P < .001), ranging from 16% to 92% of caregivers in an ICU reporting good teamwork climate. A subset of 72 ICUs repeated the culture assessment in 2005, and a 2-tailed paired samples t test showed that teamwork climate improved from 2004 to 2005, t(71) = -2.921, P < .005. Adherence to using evidence-based interventions ranged from a mean of 25% for maintaining glucose at 110 mg/dL or less to 89% for stress ulcer prophylaxis. CONCLUSION: This study describes the first statewide effort to improve patient safety in ICUs. The use of the comprehensive unit-based safety program was associated with significant improvements in safety culture. This collaborative may serve as a model to implement feasible and methodologically rigorous methods to improve and sustain patient safety on a larger scale.

Controversy and quality improvement: lingering questions about ethics, oversight, and patient safety research.

Six ethical and regulatory issues are relevant to the Michigan ICU safety program and checklist and to evidence-based patient safety initiatives in general.

The team checkup tool: evaluating QI team activities and giving feedback to senior leaders.

This tool can close the gap between hospital executives and frontline QI teams, improve knowledge of team activities, and help teams to identify and remedy barriers to progress.

Developing process-support tools for patient safety: finding the balance between validity and feasibility.

The Johns Hopkins Quality and Safety Research Group, which has developed many process-support tools--three of which are reported in this issue--describes its approach to tool development.

Statewide Collaborative to Reduce Surgical Site Infections: Results of the Hawaii Surgical Unit-Based Safety Program.

BACKGROUND: Surgical site infections (SSIs) after colorectal surgery are common, lead to patient harm, and are costly to the healthcare system. This study's purpose was to evaluate the effectiveness of the AHRQ Safety Program for Surgery in Hawaii. STUDY DESIGN: This pre-post cohort study involved 100% of 15 hospitals in Hawaii from January 2013 through June 2015. The intervention was a statewide implementation of the Comprehensive Unit-Based Safety Program and individualized bundles of interventions to reduce SSIs. Primary end point was colorectal SSIs. Secondary end point was safety culture measured by the AHRQ Hospital Survey on Patient Safety Culture. RESULTS: The most common interventions implemented were reliable chlorhexidine wash, wipe before operation, and surgical preparation; appropriate antibiotic choice, dose, and timing; standardized post-surgical debriefing; and differentiating clean-dirty-clean with anastomosis tray and closing tray. From January 2013 (quarter 1) through June 2015 (quarter 2), the collaborative colorectal SSI rate decreased (from 12.08% to 4.63%; p < 0.01). The SSI rate exhibited a linear decrease during the 10-quarter period (p = 0.005). Safety culture increased in 10 of 12 domains: Overall Perception/Patient Safety (from 49% to 53%); Teamwork Across Units (from 49% to 54%); Management-Support Patient Safety (from 53% to 60%); Nonpunitive Response to Error (from 36% to 40%); Communication Openness (from 50% to 55%); Frequency of Events Reported (from 51% to 60%); Feedback/Communication about Error (from 52% to 59%); Organizational Learning/Continuous Improvement (from 59% to 70%); Supervisor/Manager Expectations and Actions Promoting Safety (from 58% to 64%); and Teamwork Within Units (from 68% to 75%) (all p < 0.05). CONCLUSIONS: Participation in the national AHRQ Safety Program for Surgery in the state of Hawaii was associated with a 61.7% decrease in colorectal SSI rate and an increase in patient safety culture.

Intensive care unit safety incidents for medical versus surgical patients: a prospective multicenter study.

PURPOSE: The aim of this study is to determine if patient safety incidents and the system-related factors contributing to them systematically differ for medical versus surgical patients in intensive care units. MATERIALS AND METHODS: We conducted a multicenter prospective study of 646 incidents involving adult medical patients and 707 incidents involving adult surgical patients that were reported to an anonymous patient safety registry over a 2-year period. We compared incident characteristics, patient harm, and associated system factors for medical versus surgical patients. RESULTS: The proportion of safety incidents reported for medical versus surgical patients differed for only 3 of 11 categories: equipment/devices (14% vs 19%; P = .02), "line, tube, or drain" events (8% vs 13%; P = .001), and computerized physician order entry (13% vs 6%; P < or = .001). The type of patient harm associated with incidents also did not differ. System factors were similar for medical versus surgical patients, with training and teamwork being the most important factors in both groups. CONCLUSIONS: Medical and surgical patients in the intensive care unit experience very similar types of safety incidents with similar associated patient harm and system factors. Common initiatives to improve patient safety for medical and surgical patients should be undertaken with a specific focus on improving training and teamwork among the intensive care team.

Assessing content validity and user perspectives on the Team Check-up Tool: expert survey and user focus groups.

OBJECTIVE: This study assesses content validity and user feedback on the Team Check-up Tool (TCT), an instrument used for measuring dynamic context of quality improvement (QI) teams and their implementation of QI activities. METHODS: We conducted two focus groups and one larger feedback session with TCT users to assess feasibility, importance of areas of inquiry and barriers to use. A panel of eight QI experts evaluated the item-by-item content (content validity) of TCT by rating the relevance of each item to implementation success. We calculated item-level and scale-level content validity using the content validity index (CVI). RESULTS: Scale-level CVI was 0.872. Highly rated items included implementation of recommended interventions, educational activities, team review of performance data, team sharing of performance data with staff and specific barriers to progress. Four items were rated relatively low: presentation of performance data to the hospital/health system board; manner of provision of feedback of data to staff; to what other units the team attempted to spread and turnover of QI team members. Items identified in user focus groups as important included whether there were events distracting staff from the initiative, number of team meetings and turnover of QI team members. Focus groups also identified barriers to the completion of the tool, including lack of feedback and response fatigue during stable activity periods. CONCLUSION: The findings support the conclusion that the TCT measures meaningful areas of context and implementation in team-based QI initiatives, particularly intervention activity tracking, review and sharing of performance data and team progress barriers. We offer a modified instrument with a framework for real-time measurement of important elements of implementation and context of QI teams based on the findings.

Measure accurately, Act rapidly, and Partner with patients: An intuitive and practical three-part framework to guide efforts to improve hypertension control.

Hypertension is the leading cause of cardiovascular disease in the United States and worldwide. It also provides a useful model for team-based chronic disease management. This article describes the M.A.P. checklists: a framework to help practice teams summarize best practices for providing coordinated, evidence-based care to patients with hypertension. Consisting of three domains-Measure Accurately; Act Rapidly; and Partner With Patients, Families, and Communities-the checklists were developed by a team of clinicians, hypertension experts, and quality improvement experts through a multistep process that combined literature review, iterative feedback from a panel of internationally recognized experts, and pilot testing among a convenience sample of primary care practices in two states. In contrast to many guidelines, the M.A.P. checklists specifically target practice teams, instead of individual clinicians, and are designed to be brief, cognitively easy to consume and recall, and accessible to healthcare workers from a range of professional backgrounds.

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.

Creating high reliability in health care organizations.

OBJECTIVE: The objective of this paper was to present a comprehensive approach to help health care organizations reliably deliver effective interventions. CONTEXT: Reliability in healthcare translates into using valid rate-based measures. Yet high reliability organizations have proven that the context in which care is delivered, called organizational culture, also has important influences on patient safety. MODEL FOR IMPROVEMENT: Our model to improve reliability, which also includes interventions to improve culture, focuses on valid rate-based measures. This model includes (1) identifying evidence-based interventions that improve the outcome, (2) selecting interventions with the most impact on outcomes and converting to behaviors, (3) developing measures to evaluate reliability, (4) measuring baseline performance, and (5) ensuring patients receive the evidence-based interventions. The comprehensive unit-based safety program (CUSP) is used to improve culture and guide organizations in learning from mistakes that are important, but cannot be measured as rates. CONCLUSIONS: We present how this model was used in over 100 intensive care units in Michigan to improve culture and eliminate catheter-related blood stream infections--both were accomplished. Our model differs from existing models in that it incorporates efforts to improve a vital component for system redesign--culture, it targets 3 important groups--senior leaders, team leaders, and front line staff, and facilitates change management-engage, educate, execute, and evaluate for planned interventions.

Toward learning from patient safety reporting systems.

PURPOSE: To evaluate the frequency and type of factors involved in incidents reported to a patient safety reporting system and answer specific questions to enhance the value of PSRS data to improve patient safety. MATERIALS AND METHODS: Prospective cohort study of incidents reported from adult and pediatric intensive care units (ICUs) in the United States to the web-based, voluntary, and anonymous Intensive Care Unit Safety Reporting System. Results from July 1, 2002, to June 30, 2004. Main outcome variables were incidents that could or did lead to patient harm. RESULTS: Analysis includes 2075 incidents from 23 ICUs. Median number of reports/ICU/month was 3; 5 hospitals submitted 58% of reports. Harm was reported in 42% of incidents with 18 deaths. Common event types: medication/therapeutics (42%) and incorrect/incomplete care delivery (20%); 48% of line/tube/drain incidents led to physical harm. Deficiencies in training/education contributed to 49% of incidents and teamwork issues 32%; 42% of incidents had 2 or more contributing factors. As the number of contributing factors per incident increased, so did risk of harm. CONCLUSIONS: The Intensive Care Unit Safety Reporting System provides a mechanism for multiple ICUs to identify hazards. Data trends show a correlation between multiple contributing factors and higher rates of harm. Further research is needed to help determine how to use PSRS data to improve patient safety.

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.